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Recalls affecting South Dakota

Data last updated: September 10, 2026 at 1:16 PM UTC

16,341 recalls found
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Just announced

Straight from FDA press releases — not yet formally classified or risk-graded
UnclassifiedUndeclaredAnnounced September 4, 2026

Business Pill, Branch Manager for Men — dietary supplements marketed for male sexual enhancement

Products contain undeclared yohimbine

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Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

Grant-Valkaria, Florida - SUPPLX.com is voluntarily recalling Business Pill and Branch Manager for Men, products marketed as dietary supplements for male sexual enhancement, because FDA laboratory analysis confirmed that both products contain yohimbine that is not declared on the product labels.

Company contact: (321) 341-9501 · SupplxRecall@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaAnnounced September 4, 2026

Foods Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

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Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

Foods Alive Inc of Angola, IN, is recalling its 8-ounce packages of organic moringa leaf powder because they have the potential to be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced September 3, 2026

B. Braun — 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container

Presence of particulate matter identified as iron oxide

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Drugs

Recalling firm: B. Braun Medical Inc.

“On September 3, 2026 firm updated their press release to include additional contaminants.” FOR IMMEDIATE RELEASE – September 3, 2026– Bethlehem, PA, B. Braun Medical Inc (B. Braun) is voluntarily recalling three (3) lots of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container, to the hospital/healthcare facility/user level due to presence of particulate matter identified as iron…

Company contact: recalls@bbraunusa.com

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UnclassifiedBacteria/virusE. coliAnnounced September 3, 2026

Great Value — Organic Triple Berry Blend

Possible E. Coli Contamination

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Food & BeveragesFoodborne Illness

Recalling firm: Frutas y Hortalizas del Sur S.A.

September 02, 2026. Frutas y Hortalizas del Sur S.A., San Carlos, Chile expands its July 3, 2026, recall of frozen organic IQF blueberries to include one lot of Great Value frozen Organic Triple Berry Blend 10 OZ because of potential contamination with Escherichia coli O145:H28 (E. coli O145) .

Company contact: Info.foodsafety@comfrut.com

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UnclassifiedAnnounced September 3, 2026

American Regent, Inc. — Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial

Presence of particulate matter and lack of sterility assurance

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Food & Beverages

Recalling firm: American Regent, Inc.

FOR IMMEDIATE RELEASE – September 3, 2026 – New Albany, OH, American Regent, Inc. is conducting a nationwide voluntary recall of three lots of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vials to the consumer level. Customer complaints were received for leaking and cracked vials, resulting in lack of assurance of sterility.

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UnclassifiedAllergenMilkUndeclaredAnnounced August 31, 2026

Little Temptations — Chocolatey Eyeballs, 7 oz., 10 oz., 10.5 oz., 11 oz., and 16 oz.

Undeclared milk

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Food & BeveragesAllergens

Recalling firm: Crystal Temptations

Crystal Temptations of North Arlington, NJ is recalling Halloween Chocolatey Eyeballs because they contain undeclared MILK allergens. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

View FDA’s announcement (opens in a new tab)
UnclassifiedUndeclaredAnnounced August 31, 2026

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

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Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

FOR IMMEDIATE RELEASE - August 27, 2026 - Davie, Florida – Ana Salazar Modela Tu Cuerpo Inc. is recalling Lipofit Extreme Fat Burner 2.0, Lot 25M12F, expiration date 09/2027, to the consumer level.

Company contact: (954) 305-1004 · yandrydy@gmail.com

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UnclassifiedAnnounced August 31, 2026

Kofinas — Garlic Mediterranean Infused Extra Virgin Olive Oil 500 ml, 250 ml, and 100 ml

Contains garlic essential oil not approved for culinary use

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Food & BeveragesIngredients

Recalling firm: LMSI LLC

Cincinnati, OH (Aug. 29, 2026) - LMSI LLC/ Kofinas Olive Oil is issuing a voluntary recall of its Garlic Mediterranean infused extra virgin olive oil for using a garlic essential oil not approved for culinary use. The flavored oil was bottled in glass bottles in 500 ml, 250 ml, and 100 ml sizes.

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaE. coliAnnounced August 29, 2026

Everything Sprouts — Robust Radish Mix, 5oz Cups

Potential to be contaminated with Shiga toxin-producing Escherichia coli (STEC) or Salmonella.

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Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

Everything Sprouts, LLC, based in Minneapolis, MN is expanding its voluntary recall of sprouts to include certain lots of Robust Radish Sprout Mix because it has the potential to be contaminated with Shiga toxin producing Escherichia coli (STEC) or Salmonella bacteria.

Company contact: everythingsproutsmn@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaAnnounced August 29, 2026

Martina — Mangoes

Potential contamination with Salmonella

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Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

MAMARONECK, NY, AUG. 28, 2026 - Panorama Produce is recalling 302 boxes of size 9 (nine) mangoes because they may be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled June 3, 2021

HeartWare HVAD Pump Implant Kit, REF 1125

Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events and mortality associated with the system when compared to other commercially available left ventricular assist devices, as well as complaints that the internal pump may delay or fail to restart.

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▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
88197
Lot/product code:
GTIN: 00888707000222, 00888707007641, 00888707005685 All serial numbers
Recalling firm:
Heartware, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 3, 2021

HeartWare HVAD Pump Implant Kit, REF 1104

Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events and mortality associated with the system when compared to other commercially available left ventricular assist devices, as well as complaints that the internal pump may delay or fail to restart.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
88197
Lot/product code:
GTIN: 00888707003063, 00888707003070, 00888707006323, 00888707003117, 00888707006392, 00888707006408, 00888707006330, 00888707003100, 00888707003254, 00888707009140, 00888707007290, 00888707006446, 00888707008129, 00888707002608, 00888707008174, 00888707003209, 00888707006347 All serial numbers
Recalling firm:
Heartware, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 3, 2021

HeartWare HVAD Pump Implant Kit, REF 1103

Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events and mortality associated with the system when compared to other commercially available left ventricular assist devices, as well as complaints that the internal pump may delay or fail to restart.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
88197
Lot/product code:
GTIN: 00888707003261 All serial numbers
Recalling firm:
Heartware, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 3, 2021

HeartWare HVAD Pump Implant Kit, REF 1153

Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events and mortality associated with the system when compared to other commercially available left ventricular assist devices, as well as complaints that the internal pump may delay or fail to restart.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
88197
Lot/product code:
GTIN: 00888707000147 All serial numbers
Recalling firm:
Heartware, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 3, 2021

VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior to reaching the Explant battery indicator) when the device's battery exhibits high internal impedance. This latent battery condition puts a device at risk for system resets to occur due to temporary high-power consumption related to telemetry attempts and subsequent reversion to Safety Mode to maintain back-up pacing. Although therapy is still provided when a device is in Safety Mode, replacement is required. - Only dual chamber INGENIO family pacemakers and CRT-Ps built with the Extended Life (EL) battery are included within this advisory population

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
88107
Lot/product code:
a) J274, Serial Numbers: 100000, 100001, 100005, 100008, 100009, 100010, 100016, 100017, 100019, 100021, 100026, 100028, 100031, 100032, 100033, 100034, 100036, 100037, 100038, 100041, 100042, 100044, 100045, 100046, 100047, 100049, 100051, 100052, 100055, 100056, 100057, 100060, 100062, 100075, 100084, 100088, 100095, 100098, 100100, 100101, 100102, 100103, 100106, 100107, 100109, 100112, 100114, 100115, 100116, 100118, 100120, 100121, 395016, 100012, 100013, 100018, 100020, 100029, 100030, 100043, 100054, 100065, 100105, 100117, 394733, 394736, 394741, 394742, 394743, 394745, 394746, 394747, 394748, 394749, 394750, 394751, 394752, 394753, 394754, 394755, 394756, 394757, 394758, 394759, 394762, 394763, 394764, 394765, 394766, 394767, 394768, 394769, 394770, 394771, 394772, 394773, 394774, 394775, 394776, 394777, 394778, 394779, 394780, 394781, 394782, 394783, 394784, 394785, 394786, 394787, 394788, 394789, 394790, 394791, 394792, 394793, 394794, 394795, 394796, 394797, 394798, 394799, 394800, 394801, 394802, 394803, 394804, 394805, 394806, 394807, 394808, 394809, 394810, 394811, 394812, 394813, 394814, 394815, 394816, 394817, 394818, 394819, 394820, 394821, 394825, 394826, 394827, 394828, 394829, 394830, 394831, 394832, 394833, 394834, 394835, 394836, 394837, 394838, 394839, 394840, 394841, 394842, 394843, 394844, 394845, 394846, 394847, 394848, 394849, 394850, 394851, 394852, 394853, 394854, 394855, 394856, 394857, 394858, 394859, 394860, 394861, 394862, 394863, 394864, 394865, 394866, 394867, 394868, 394869, 394870, 394871, 394874, 394875, 394876, 394877, 394878, 394879, 394880, 394882, 394883, 394884, 394885, 394886, 394887, 394888, 394890, 394891, 394892, 394893, 394894, 394895, 394896, 394897, 394898, 394899, 394900, 394901, 394902, 394903, 394905, 394906, 394907, 394908, 394909, 394910, 394911, 394912, 394915, 394916, 394917, 394918, 394919, 394920, 394921, 394922, 394923, 394924, 394925, 394926, 394927, 394928, 394929, 394931, 394932, 394933, 394934, 394935, 394936, 394937, 394938, 394939, 394940, 394941, 394942, 394943, 394944, 394945, 394946, 394947, 394948, 394949, 394950, 394951, 394952, 394953, 394954, 394955, 394956, 394957, 394958, 394959, 394960, 394961, 394962, 394963, 394964, 394965, 394966, 394967, 394968, 394969, 394970, 394971, 394972, 394973, 394974, 394975, 394976, 394977, 394978, 394979, 394980, 394981, 394982, 394983, 394984, 394985, 394986, 394987, 394988, 394989, 394990, 394991, 394992, 394993, 394994, 394995, 394996, 394997, 394998, 394999, 395000, 395001, 395002, 395003, 395004, 395005, 395006, 395007, 395008, 395009, 395010, 395011, 395013, 395014, 395017, 395018, 395019, 395020, 395022, 395023, 395024, 395025, 395026, 395027, 395028, 395029, 395030, 395031, 395032, 395033, 395034, 395035, 395036, 395037, 395038, 395039, 395040, 395041 b) J277, Serial Numbers: 101302, 104161, 100001, 100002, 100003, 100005, 100007, 100009, 100010, 100011, 100012, 100013, 100014, 100015, 100016, 100020, 100021, 100022, 100024, 100025, 100027, 100028, 100029, 100030, 100031, 100033, 100034, 100035, 100037, 100039, 100040, 100041, 100042, 100044, 100045, 100047, 100049, 100051, 100052, 100057, 100061, 100062, 100071, 100108, 100111, 100130, 100143, 100158, 100240, 100248, 100277, 100313, 100330, 100417, 100421, 100427, 100445, 100450, 100452, 100457, 100475, 100486, 100494, 100516, 100553, 100555, 100563, 100576, 100611, 100686, 100736, 100749, 100779, 100780, 100807, 100839, 100864, 100886, 100916, 100923, 100964, 100969, 100983, 100988, 101018, 101042, 101062, 101073, 101093, 101122, 101157, 101302, 101305, 101322, 101420, 101437, 101452, 101502, 101672, 101766, 101793, 101797, 101915, 101929, 102052, 102080, 102137, 102218, 102276, 102310, 102315, 102335, 102368, 102395, 102428, 102475, 102496, 102506, 102526, 102542, 102553, 102554, 102573, 102576, 102589, 102606, 102647, 102653, 102654, 102672, 102703, 102710, 102767, 102793, 102805, 102842, 102853, 102961, 103001, 103029, 103032, 103159, 103221, 103235, 103259, 103391, 103410, 103483, 103506, 103531, 103551, 103743, 103758, 103820, 103838, 103890, 103930, 104056, 104058, 104090, 104161, 104187, 104246, 104358, 104422, 104487, 104502, 104796, 104798, 104802, 104855, 104872, 104957, 104985, 105136, 105167, 105234, 431078, 431204, 431361, 431408, 431427, 431438, 431482, 431505, 431506, 431550, 431599, 431717, 431749, 431962, 432068, 432161, 432171, 432210, 432250, 432425, 432446, 432569, 432590, 432693, 432878, 432907, 432916, 432986, 433029, 433058, 433075, 433247, 433258, 433268, 433288, 433301, 433376, 433436, 433447, 433448, 433450, 433452, 433453, 433454, 433455, 433456, 433457, 433458, 433460, 433462, 433464, 433469, 433479, 433489, 100070, 100072, 100073, 100074, 100075, 100076, 100078, 100079, 100080, 100082, 100083, 100084, 100085, 100086, 100087, 100088, 100089, 100090, 100091, 100092, 100093, 100094, 100095, 100096, 100097, 100098, 100099, 100100, 100101, 100102, 100103, 100104, 100105, 100106, 100107, 100109, 100110, 100112, 10011… (truncated, 132635 characters total — see the official FDA record for the full value)
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 3, 2021

INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273

The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior to reaching the Explant battery indicator) when the device's battery exhibits high internal impedance. This latent battery condition puts a device at risk for system resets to occur due to temporary high-power consumption related to telemetry attempts and subsequent reversion to Safety Mode to maintain back-up pacing. Although therapy is still provided when a device is in Safety Mode, replacement is required. - Only dual chamber INGENIO family pacemakers and CRT-Ps built with the Extended Life (EL) battery are included within this advisory population

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
88107
Lot/product code:
a) V272, Serial Numbers: 100002, 100014, 100017, 100021, 100028, 100037, 100048, 100052, 100053, 100054, 100065, 100067, 100068, 100075, 100077, 100080, 100092, 100093, 100096, 100097, 100098, 100099, 100101, 100104, 100106, 100107, 100108, 100114, 100116, 100118, 100119, 100120, 100124, 100127, 100136, 100152, 100153, 100155, 100159, 100161, 100162, 100165, 100168, 100170, 100171, 100173, 100175, 100176, 100179, 100194, 100195, 100199, 100201, 100202, 100203, 100205, 100206, 100211, 100212, 100216, 100218, 100219, 100221, 100224, 100226, 100227, 100228, 100230, 100232, 100233, 100237, 100238, 100240, 100241, 100242, 100245, 100247, 100249, 100250, 100253, 100256, 100257, 100258, 100261, 100266, 100270, 100272, 100276, 100277, 100280, 100281, 100287, 100289, 100290, 604977, 604982, 604984, 604986, 604987, 604988, 604991, 604992, 604998, 604999, 605002, 605003, 605004, 605005, 605006, 605007, 605009, 605010, 605011, 605013, 605014, 605015, 605017, 605020, 605021, 605022, 605023, 605025, 605026, 605027, 605028, 605029, 605035, 605036, 605037, 605039, 605041, 605047, 605049, 605051, 605052, 605055, 605057, 605058, 605061, 605062, 605063, 605064, 605065, 605070, 605073, 605075, 605076, 605079, 605080, 605082, 605085, 605087, 605088, 605090, 605096, 605098, 605099, 605100, 605103, 605108, 605112, 605115, 605117, 605118, 605120, 605124, 605127, 605128, 605129, 605133, 605135, 605136, 605137, 605140, 605141, 605147, 605149, 605150, 605151, 605152, 605153, 605154, 605155, 605158, 605159, 605161, 605162, 605163, 605164, 605166, 605168, 605170, 605172, 605173, 605174, 605175,   b) V273, Serial Numbers: 100001, 100002, 100006, 100007, 100013, 100014, 100015, 100017, 100019, 100030, 100032, 100033, 100034, 100035, 100036, 100037, 100038, 100042, 100044, 100045, 100046, 100047, 100048, 100049, 100054, 100056, 100057, 100058, 100060, 100062, 100066, 100067, 100069, 100071, 100072, 100076, 100083, 100084, 100086, 100087, 100088, 100089, 100090, 100091, 100093, 100096, 100097, 100100, 100101, 100103, 100104, 100107, 100116, 100117, 100118, 100119, 100120, 100121, 100123, 100126, 100128, 100131, 100134, 100135, 100138, 100139, 100140, 100141, 100142, 100143, 100146, 100148, 100152, 100154, 100155, 100156, 100157, 100159, 100166, 100168, 100174, 100175, 100180, 100182, 100184, 100185, 100187, 100192, 100197, 100199, 100201, 100202, 100206, 100209, 100211, 100212, 100213, 100219, 100227, 100229, 100230, 100232, 100234, 100235, 100237, 100241, 100242, 100244, 100245, 100249, 100250, 100251, 100253, 100254, 100255, 100259, 100263, 100265, 100266, 100270, 100275, 100277, 100284, 100285, 100286, 100288, 100289, 100290, 100294, 100296, 100298, 100299, 100300, 100301, 100302, 100303, 100304, 100306, 100307, 100309, 100311, 100317, 100319, 100320, 100321, 100322, 100323, 100324, 100325, 100326, 100327, 100328, 100333, 100334, 100335, 100336, 100339, 100340, 100341, 100344, 100345, 100347, 100348, 100349, 100350, 100352, 100353, 100355, 100357, 100358, 100361, 100363, 100366, 100367, 100369, 100370, 100375, 100376, 100377, 100378, 100379, 100380, 100381, 100382, 100383, 100385, 100386, 100388, 100390, 100394, 100396, 100397, 100398, 100402, 100404, 100405, 100407, 100408, 100414, 100417, 100419, 100426, 100428, 100429, 100430, 100431, 100432, 100434, 100435, 100436, 100437, 100439, 100442, 100443, 100444, 100445, 100446, 100452, 100455, 100457, 100459, 100460, 100461, 100464, 100465, 100466, 100469, 100476, 100479, 100481, 100484, 100486, 100487, 100488, 100491, 100494, 100496, 100500, 100503, 100504, 100505, 100510, 100511, 100513, 100516, 100517, 100518, 100519, 100520, 100523, 100526, 100528, 100531, 100533, 100535, 100536, 100541, 100542, 100543, 100544, 100547, 100549, 100551, 100555, 100556, 100557, 100559, 100560, 100561, 100562, 100563, 100564, 100566, 100567, 100572, 100573, 100574, 100575, 100578, 100579, 100580, 100583, 100584, 100588, 100589, 100591, 100592, 100593, 100594, 100595, 100596, 100597, 100603, 100604, 100605, 100607, 100608.100611, 100613, 100615, 100617, 100618, 100622, 100627, 100629, 100630, 100632, 100637, 100638, 100641, 100643, 100644, 100645, 100646, 100647, 100653, 100654, 100658, 100659, 100660, 100661, 100664, 100665, 100666, 100667, 100668, 100669, 100670, 100671, 100674, 100675, 100676, 100679, 100680, 100682, 100683, 100684, 100685, 100686, 100687, 100688, 100689, 100690, 100692, 100693, 100694, 100695, 100697, 100700, 100701, 100702, 100706, 100708, 100709, 100712, 100714, 100715, 100716, 100717, 100719, 100721, 100722, 100723, 100725, 100726, 100727, 100730, 100731, 100735, 100736, 100740, 100742, 100744, 100745, 100747, 100748, 100751, 100753, 100755, 100757, 100758, 100759, 100761, 100763, 100764, 100765, 100766, 100767, 100769, 100774, 100776, 100779, 100781, 100782, 100783, 100784, 100787, 100788, 100789, 100791, 100795, 100797, 100798, 100799, 100805, 100806, 100807, 100808, 100810, 100812, 100814, 100815, 100816, 100817, 100818, 100820, 100821, 100822, 100824, 100825, 100826, 100827, 100… (truncated, 13731 characters total — see the official FDA record for the full value)
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 3, 2021

Proponent pacemaker, Models: a) L200 b) L201 c) L209 d) L210 e) L211 f) L221 g) L231

Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in accelerated battery depletion of the battery and associated progression of displayed battery depletion indicators.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
88087
Lot/product code:
a) L200, Serial Numbers: 464370, 464446, 464458, 464460, 464462, 464468, 464470, 464475, 464481, 464482, 464483, 464490, 464498, 464500, 464508, 464512, 464516, 464519, 464526, 464528, 464532, 464563, 464590, 705134, 705580, 705587, 705711, 705751, 706215, 708261, 708589, 708797, 708798, 708802, 708815, 708819, 708820, 708832, 708841, 708843, 708844, 708848, 708851, 708858, 708859, 708874, 708877, 708883, 708886, 708892, 708896, 708907, 708910, 708913, 708914, 708917, 708923, 708928, 708932, 708933, 708935, 708936, 708937, 708938, 708940, 708941, 708943, 708956, 708958, 708963, 708974, 708977, 708981, 708982, 708986, 708987, 709002, 709004, 709006, 709007, 709008, 709013, 709016, 709027, 709033, 709034, 709039, 709042, 709044, 709045, 711776, 711780, 711795, 711804, 711814, 711823, 711839, 711852, 711866, 711868, 711875, 711893, 711894, 711899, 711914, 711917, 711925, 711938, 711947, 711954, 711971, 711997, 712053, 712056, 712084, 712086, 712088, 712093, 712098, 712125, 712129, 712131, 712174, 712177, 712178, 712219, 712232, 712239, 712249, 712257, 712279, 712284, 712286, 712290, 712350, 712352, 712385, 712390, 712410, 712414, 712428, 712436, 712442, 712449, 712470, 712475, 712489, 712491, 712521, 712537, 712571, 712598, 712631, 712848, 713367, 714102, 714105, 714785, 719943, 720012, 720109, 720110, 720119, 720142, 720228, 464359, 464382, 464387, 464388, 464444, 464447, 464452, 464457, 464467, 464471, 464473, 464477, 464486, 464491, 464492, 464501, 464505, 464506, 464511, 464514, 464517, 464521, 464523, 464525, 464527, 464541, 464549, 464552, 464554, 464561, 464568, 464570, 464576, 464694, 705236, 705383, 705409, 705419, 705462, 705468, 705555, 705563, 705576, 705579, 705584, 705591, 705622, 705628, 705702, 705706, 705713, 705728, 705753, 705795, 705812, 706007, 706098, 706200, 706256, 706321, 706328, 706350, 706372, 706379, 706392, 706441, 706698, 706846, 706879, 706918, 706923, 706931, 706947, 706967, 707053, 707069, 707089, 707138, 707173, 708351, 708585, 708595, 708618, 708619, 708620, 708764, 708816, 708824, 708826, 708831, 708853, 708857, 708862, 708867, 708868, 708879, 708880, 708885, 708887, 708889, 708894, 708898, 708905, 708912, 708915, 708916, 708918, 708920, 708922, 708924, 708925, 708929, 708930, 708939, 708942, 708944, 708945, 708946, 708947, 708948, 708949, 708950, 708952, 708959, 708960, 708965, 708966, 708967, 708968, 708969, 708971, 708975, 708976, 708978, 708980, 708983, 708984, 708992, 708997, 709000, 709003, 709009, 709014, 709023, 709024, 709025, 709029, 709037, 709040, 709041, 709043, 711763, 711765, 711768, 711771, 711773, 711777, 711791, 711843, 711863, 711865, 711867, 711869, 711870, 711872, 711879, 711885, 711887, 711890, 711897, 711898, 711910, 711915, 711918, 711922, 711923, 711924, 711926, 711927, 711928, 711929, 711931, 711942, 711946, 711963, 711965, 711970, 711980, 711982, 711987, 712009, 712017, 712026, 712058, 712083, 712107, 712114, 712137, 712145, 712210, 712255, 712256, 712264, 712302, 712312, 712321, 712396, 712397, 712459, 712477, 712534, 712742, 712820, 712829, 712843, 713710, 714062, 714791, 714827, 715058, 719969, 719972, 720019, 720122, 720124, 720132, 720134, 720135, 720141, 720144, 720145, 720147, 720172, 720173, 720183, 720184, 720191, 720198, 720234, 720240, 720242, 720250, 720309. b) L201, Serial Numbers: 100197, 100197, 716267, 716291, 716760, 716845, 716997, 718600, 718990, 742235, 742270, 742333, 742343, 742359, 742372, 742390, 742461, 742514, 742556, 742588, 742625, 742754, 743187, 743229, 743329, 743535, 744054, 746443, 746451, 751482, 100140, 100164, 100165, 100174, 100181, 100186, 100221, 100243, 100282, 100287, 100290, 100401, 100407, 100410, 100707, 100750, 100827, 100838, 100839, 716162, 716208, 716288, 716289, 716290, 716309, 716419, 716421, 716423, 716424, 716426, 716435, 716605, 716629, 716641, 716715, 716750, 716759, 716769, 716779, 716803, 716836, 716868, 716990, 716994, 717000, 717009, 717034, 717040, 717053, 717070, 717077, 717083, 717098, 717099, 717108, 717118, 717124, 717153, 717156, 717166, 717182, 717189, 717197, 717248, 717250, 717274, 717302, 717306, 717310, 717314, 717369, 717378, 717413, 717491, 717504, 717525, 717533, 717570, 717577, 717583, 717593, 717600, 717653, 717700, 717816, 717877, 717878, 717885, 717896, 717906, 717917, 717931, 717963, 717978, 717991, 717994, 717996, 718005, 718021, 718137, 718242, 718418, 718492, 718494, 718504, 718528, 718552, 718558, 718601, 718605, 718608, 718617, 718627, 718630, 718631, 718640, 718659, 718667, 718668, 718672, 718675, 718676, 718680, 718683, 718697, 718705, 718711, 718713, 718716, 718733, 718743, 718747, 718748, 718762, 718775, 718778, 718784, 718794, 718801, 718805, 718806, 718807, 718820, 718831, 718833, 718852, 718860, 718868, 718881, 718882, 718883, 718890, 718892, 718893, 718894, 718896, 718900, 718901, 718908, 718914, 718915, 718931, 718972, 718979, 718989, 719003, 719014, 719016, 719045, 719948, 724869, 725647, 725651, 725749, 725774, 725775, 725787, 725949, 726012, 726021, 72602… (truncated, 181610 characters total — see the official FDA record for the full value)
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 3, 2021

VISIONIST CRT-P pacemaker, Models: a) U225 b) U226 c) U228

Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in accelerated battery depletion of the battery and associated progression of displayed battery depletion indicators.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
88087
Lot/product code:
a) U225, Serial Numbers: 707340, 100094, 100142, 100152, 100160, 100184, 100309, 100364, 100807, 100880, 100908, 100913, 700015, 700197, 700469, 700559, 700563, 700576, 700586, 700598, 700613, 700655, 700681, 700682, 700722, 700725, 700782, 700824, 700895, 700942, 700961, 700998, 701017, 701030, 701045, 701094, 701118, 701127, 701212, 701230, 701264, 701336, 701339, 701343, 701407, 701477, 701504, 702448, 702462, 702471, 702654, 702673, 702685, 702809, 703137, 703696, 703697, 703784, 703827, 703875, 703883, 703998, 707324, 707337, 707338, 707347, 707348, 707398, 707430, 707477, 707502, 707503, 707505, 707510, 707511, 707512, 707522, 707524, 707538, 707546, 707566, 707587, 707590, 707597, 100016, 100021, 100023, 100048, 100053, 100059, 100060, 100061, 100064, 100065, 100070, 100072, 100073, 100075, 100077, 100082, 100087, 100088, 100089, 100090, 100093, 100097, 100098, 100100, 100101, 100103, 100105, 100107, 100108, 100109, 100113, 100114, 100115, 100116, 100117, 100118, 100120, 100121, 100122, 100123, 100125, 100126, 100128, 100129, 100130, 100131, 100134, 100135, 100137, 100138, 100140, 100143, 100144, 100145, 100147, 100151, 100153, 100154, 100155, 100156, 100161, 100168, 100169, 100170, 100172, 100173, 100174, 100176, 100181, 100183, 100185, 100186, 100187, 100190, 100191, 100195, 100196, 100197, 100198, 100233, 100238, 100241, 100252, 100266, 100269, 100271, 100273, 100276, 100278, 100282, 100289, 100293, 100296, 100304, 100312, 100313, 100316, 100388, 100395, 100398, 100424, 100428, 100471, 100543, 100545, 100579, 100581, 100595, 100602, 100604, 100610, 100616, 100627, 100712, 100717, 100720, 100734, 100747, 100787, 100800, 100804, 100806, 100810, 100819, 100827, 100828, 100832, 100834, 100835, 100845, 100849, 100850, 100851, 100852, 100853, 100856, 100858, 100865, 100874, 100879, 100887, 100888, 100889, 100890, 100892, 100894, 100895, 100900, 100901, 100902, 100905, 100906, 100907, 100909, 100915, 100916, 100917, 100919, 100921, 100922, 100923, 100924, 100926, 100928, 100929, 100930, 100931, 100932, 100933, 100934, 100935, 700002, 700006, 700013, 700016, 700021, 700024, 700025, 700027, 700035, 700039, 700040, 700043, 700044, 700047, 700048, 700052, 700056, 700060, 700063, 700064, 700067, 700071, 700075, 700077, 700080, 700082, 700083, 700084, 700085, 700088, 700089, 700092, 700094, 700099, 700100, 700102, 700103, 700104, 700105, 700108, 700109, 700110, 700115, 700121, 700125, 700128, 700132, 700134, 700138, 700142, 700145, 700146, 700148, 700151, 700152, 700153, 700155, 700156, 700157, 700159, 700160, 700165, 700170, 700180, 700188, 700189, 700198, 700202, 700203, 700205, 700206, 700209, 700210, 700211, 700214, 700215, 700216, 700217, 700221, 700222, 700225, 700246, 700249, 700268, 700271, 700274, 700278, 700279, 700281, 700285, 700288, 700291, 700292, 700389, 700425, 700427, 700428, 700429, 700430, 700431, 700432, 700433, 700434, 700435, 700446, 700447, 700448, 700449, 700450, 700451, 700452, 700453, 700454, 700455, 700457, 700458, 700459, 700461, 700462, 700463, 700464, 700465, 700467, 700468, 700470, 700471, 700472, 700473, 700474, 700475, 700476, 700477, 700478, 700479, 700480, 700481, 700482, 700483, 700484, 700485, 700486, 700487, 700490, 700491, 700492, 700493, 700494, 700495, 700496, 700497, 700498, 700499, 700500, 700503, 700504, 700506, 700508, 700510, 700511, 700512, 700513, 700514, 700515, 700516, 700522, 700523, 700524, 700525, 700526, 700527, 700528, 700529, 700530, 700531, 700532, 700533, 700534, 700535, 700536, 700537, 700538, 700540, 700541, 700542, 700543, 700544, 700545, 700546, 700547, 700548, 700549, 700550, 700551, 700553, 700555, 700558, 700560, 700561, 700562, 700564, 700566, 700567, 700568, 700570, 700571, 700572, 700573, 700574, 700575, 700577, 700578, 700579, 700580, 700581, 700583, 700584, 700585, 700587, 700588, 700590, 700591, 700592, 700593, 700594, 700595, 700596, 700597, 700599, 700600, 700603, 700604, 700605, 700606, 700607, 700608, 700609, 700610, 700611, 700612, 700614, 700615, 700616, 700617, 700620, 700622, 700623, 700624, 700625, 700626, 700627, 700628, 700629, 700631, 700632, 700633, 700635, 700636, 700637, 700639, 700640, 700641, 700642, 700643, 700644, 700645, 700647, 700648, 700651, 700652, 700653, 700654, 700658, 700659, 700660, 700661, 700663, 700664, 700665, 700666, 700667, 700668, 700670, 700671, 700672, 700673, 700674, 700676, 700677, 700679, 700680, 700683, 700684, 700686, 700687, 700688, 700689, 700690, 700691, 700693, 700694, 700695, 700696, 700698, 700699, 700704, 700705, 700710, 700711, 700712, 700714, 700715, 700716, 700717, 700718, 700719, 700720, 700723, 700724, 700727, 700728, 700729, 700730, 700731, 700732, 700733, 700734, 700736, 700737, 700739, 700740, 700741, 700742, 700743, 700745, 700748, 700749, 700750, 700751, 700752, 700753, 700754, 700755, 700756, 700757, 700758, 700760, 700761, 700764, 700766, 700767, 700768, 700770, 700772, 700773, 700774, 700775, 700776, 700778, 700779, 700780, 700781, 700783, 700785, 700788, 700789, 700790, 700791… (truncated, 47436 characters total — see the official FDA record for the full value)
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 4, 2021

Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System

GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
88147
Lot/product code:
N/A
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 4, 2021

SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance

GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
88147
Lot/product code:
N/A
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 4, 2021

SIGNA Architect - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.

GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
88147
Lot/product code:
N/A
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 4, 2021

SIGNA Pioneer - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.

GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
88147
Lot/product code:
N/A
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 4, 2021

Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System

GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
88147
Lot/product code:
N/A
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 4, 2021

Discovery MR750 3.0T - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.

GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
88147
Lot/product code:
N/A
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 4, 2021

SIGNA Creator, SIGNA Explorer, Nuclear Magnetic Resonance Imaging System

GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
88147
Lot/product code:
N/A
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 4, 2021

SIGNA Premier - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.

GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
88147
Lot/product code:
Not Available
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 4, 2021

1.5T SIGNA HDxt (HD28) MR System, Nuclear Magnetic Resonance Imaging System

GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
88147
Lot/product code:
N/A
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 4, 2021

SIGNA MR355, SIGNA MR360, Nuclear Magnetic Resonance Imaging System

GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
88147
Lot/product code:
N/A
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 4, 2021

SIGNA Artist, Nuclear Magnetic Resonance Imaging System

GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
88147
Lot/product code:
N/A
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 4, 2021

Discovery MR750w 3.0T - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.

GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
88147
Lot/product code:
N/A
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 4, 2021

SIGNA MR380, Nuclear Magnetic Resonance Imaging System

GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
88147
Lot/product code:
N/A
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 4, 2021

SIGNA Voyager, Nuclear Magnetic Resonance Imaging System

GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
88147
Lot/product code:
N/A
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 9, 2021

Chantix (varenicline) tablets, 0.5mg*, 56 Tablets, Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc., NY, NY 10017, Made in Ireland. NDC 0069-0468-56

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

ALL 50 STATES
▸Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0699-2021
Lot/product code:
Lots 00019213, Exp 31 Jan 2022 & EC6994, Exp May 31, 2023
Recalling firm:
Pfizer Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 9, 2021

Chantix (varenicline) tablets, 1 mg, 56 Tablets, Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc., NY, NY 10017, Made in Ireland. NDC 0069-0469-56

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit

ALL 50 STATES
▸Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0701-2021
Lot/product code:
Lots EC9843, Exp 31, Mar 2023; EA6080, Exp. 31, Mar 2023.
Recalling firm:
Pfizer Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 9, 2021

Chantix (varenicline)Tablets, Contains: 1 Starting Week (0.5 mg* x 11 tablets), 3 Continuing Weeks (1 mg x 42 tablets), Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017, Made in Ireland, NDC 0069-0471-03.

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit

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A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0700-2021
Lot/product code:
Lots 00020231, Exp 30 Sept 2021; 00020232, Exp 30 Nov 2021; 00020357, Exp 31 Dec 2021; 00020358, Exp 31, Jan 2022; 00020716, Exp 31, Jan 2022 ; ET1600, Exp 31, Jan 2023; ET1607, Exp 31, Jan 2023 & ET1609, Exp 31, Jan 2023.
Recalling firm:
Pfizer Inc.
View official FDA record (opens in a new tab)