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FDA food · drug · device recalls, merged

Before you eat it, take it, or plug it in — check.

Big Nope pulls three separate FDA recall feeds into one list per state, so you’re not searching three government databases to get one answer.

Just announced

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

Business Pill, Branch Manager for Mendietary supplements marketed for male sexual enhancement

Products contain undeclared yohimbine

Full report
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/virusAnnounced September 4, 2026

Foods AliveMoringa Leaf Powder

Potential to be contaminated with Salmonella

Full report
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. Braun0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container

Presence of particulate matter identified as iron oxide

Full report
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

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

Great ValueOrganic Triple Berry Blend

Possible E. Coli Contamination

Full report
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

View FDA’s announcement (opens in a new tab)
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

Full report
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.

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

LipofitLipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

Full report
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

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

KofinasGarlic Mediterranean Infused Extra Virgin Olive Oil 500 ml, 250 ml, and 100 ml

Contains garlic essential oil not approved for culinary use

Full report
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)
UnclassifiedAllergenUndeclaredAnnounced August 31, 2026

Little TemptationsChocolatey Eyeballs, 7 oz., 10 oz., 10.5 oz., 11 oz., and 16 oz.

Undeclared milk

Full report
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)
UnclassifiedBacteria/virusAnnounced August 29, 2026

Everything SproutsRobust Radish Mix, 5oz Cups

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

Full report
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/virusAnnounced August 29, 2026

MartinaMangoes

Potential contamination with Salmonella

Full report
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)

Recalls nationwide

Data last updated: September 7, 2026 at 12:15 AM UTC

19,224 recalls found
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled April 29, 2015

HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure.

Complaints with the HVAD Discolored and Cracked Driveline Outer Sheath.

Full report

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

Recall #:
71241
Lot/product code:
Catalog #'s US: 1101 and 1103 / OUS: 1100, 1101, 1102, 1104, 1104JP and 1205. Serial #: ALL HeartWare HVAD systems currently in use.
Recalling firm:
HeartWare Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 29, 2015

HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure.

Complaints with the HVAD Abnormal Power Source Switching.

Full report

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

Recall #:
71240
Lot/product code:
Catalog #'s US: 1101 and 1103 / OUS: 1100,1101,1102,1104,1104JP and 1205. Serial #: ALL HeartWare HVAD systems currently in use.
Recalling firm:
HeartWare Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 29, 2015

HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100,1101,1102,1104,1104JP and 1205. For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure.

Complaints with the HVAD Internal Controller Alarm Battery failures.

ALL 50 STATES
Full report

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

Recall #:
71239
Lot/product code:
Serial #: ALL HeartWare HVAD systems currently in use.
Recalling firm:
HeartWare Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 29, 2015

HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100, 1101,1102,1104,1104JP and 1205. Product Usage: For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure.

HeartWare has received complaints relating to damage or bent connection pins within the power supply ports of the VAD controller.

ALL 50 STATES
Full report

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

Recall #:
71164
Lot/product code:
Serial #: ALL HeartWare HVAD systems currently in use.
Recalling firm:
HeartWare Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 29, 2015

HeartWare Ventricular Assist System (HVAD). Catalog #: 1101, 1103, 1100, 1101, 1102, 1104, 1104JP, and 1205. Intended for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage heart failure.

Complaints with the HVAD Retraction of Pins within the driveline connector.

ALL 50 STATES
Full report

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

Recall #:
71242
Lot/product code:
Serial #: ALL HeartWare HVAD systems currently in use.
Recalling firm:
HeartWare Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 29, 2015

HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline cable once an electrical break has been identified. These repairs are limited to the portion of the driveline that is outside the patient boundary (exit side).

Failures of the splice repair kit if exposed to excessive force.

ALL 50 STATES
Full report

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

Recall #:
71099
Lot/product code:
Catalog #: ASY00116: HVAD Pump Driveline Splice Kit Lot #'s 532770, 567949, 480786, 483769, 490692, 539664, and 598189 and Catalog #: ASY00281: HVAD Pump Driveline Splicekit; Large OD Sheath Lot #'s 654090, 672401, 678800, 690423, 833963, 873159, and 880816
Recalling firm:
HeartWare Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 20, 2015

NaturaLyte Liquid Bicarbonate Concentrate (Dialysate Concentrate for Hemodialysis (liquid), 6.4 Liter Bottle Catalog Number: 08-4000-LB This concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.

Bacterial contamination.

ALL 50 STATES
Full report

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

Recall #:
71160
Lot/product code:
Affected lots begin with: 14DMLB, 14EMLB, 14HMLB, 14JMLB, 14KMLB, 14LMBL, 14NMLB, 14PMLB, and 14SMLB.
Recalling firm:
Fresenius Medical Care Holdings, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 9, 2015

Olympus Scientific Solutions Americas Analytical X-ray System. Delta, Delta Element, Delta Plus, DPO-4000-XX-U-EN-EN-PM-SP12, DPO-6000-XX-U-EN-EN-AP-SP10. Mobile X-ray System.

Higher than published scatter around the probe head when testing some samples. At the point the customer would interact directly with the instrument (Trigger position), most readings were lower. However, measurements around the probe head were higher particularly on samples know to be highly scattering (plastics, soils) with minimal increases on high density samples (steel, aluminum).

ALL 50 STATES
Full report

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

Recall #:
71649
Lot/product code:
Delta, Delta Element, Delta Plus, DPO-4000-XX-U-EN-EN-PM-SP12, DPO-6000-XX-U-EN-EN-AP-SP10.
Recalling firm:
Olympus Scientific Solutions Americas
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 30, 2015

KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3795-01 --- Also labeled under NOVAPLUS label NDC 0409-3795-49

Crystallization; identified as calcium salt of Ketorolac

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-1241-2015
Lot/product code:
31077DK, 31078DK, 31338DK, 31339DK, 31340DK, EXP 01JUL2015; 32068DK, 32069DK, EXP 01AUG2915; 33270DK, EXP 01SEP2015; 34084DK, 34085DK, 34161DK, 34162DK, 34298DK, 34299DK, 34300DK, EXP 01OCT2015; 35011DK, 35081DK, 35082DK, 35116DK, EXP 01NOV2015; 38139DK, 38140DK, 36144DK, EXP 01FEB2016; 39256DK, 39257DK, EXP 01MAR2016; 42210DK, 42227DK, EXP01JUN2016; 43017DK, 43116DK, 43117DK, 43292DK, 43293DK, EXP 01JUL2016; 45034DK, 45035DK, 45118DK, 45120DK, EXP 01SEP2016; 46310DK, 46311DK, EXP 01OCT2016 AND NOVAPLUS LOTS 32106DK, 32220DK, 32221DK, EXP 01AUG2015; 33235DK, 33236DK, EXP 01SEP2015; 34163DK, 34164DK, EXP 01OCT2015; 39263DK, 39264DK, EXP 01MAR2016
Recalling firm:
Hospira Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 30, 2015

KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3796-01 ---- ALSO labeled under NOVAPLUS label NDC 0409-3796-49

Crystallization; identified as calcium salt of Ketorolac

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-1242-2015
Lot/product code:
31075DK, 31076DK, EXP01JUL2015; 32345DK, 32368DK, EXP 01AUG2015; 33152DK, EXP 01SEP2015; 34538DK, EXP 01OCT2015; 37227DK, EXP 01JAN2016, 41525DK, 42255DK, EXP 01MAY2016; 46042DK, 46045DK, 46048DK, 46304DK, 46305DK, 46432DK, 46433DK, EXP 01OCT2016 AND NOVAPLUS LOT 31074DK, EXP 01JUL2015
Recalling firm:
Hospira Inc.
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled July 2, 2015

Zero Xtreme High Performance Fat Burner capsules, 30-count bottle, Distributed by Xtreme Z Distributors, Inc., Miami, FL 33180

Marketed Without an Approved NDA/ANDA: FDA sampling and analysis confirmed the presence of sibutramine and desmethylsibutramine.

ALL 50 STATES
Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
D-1165-2016
Lot/product code:
Lot 1220062085, Exp. 09/16
Recalling firm:
XTREME Z DISTRIBUTORS INC
View official FDA record (opens in a new tab)
Class IHigh risk
DrugUndeclaredRecalled July 13, 2015

Akttive High Performance Fat Burner Gold dietary supplement capsules, 30-count bottle, Distributed by Life and More, L.L.C., Doral, Florida

Marketed Without An Approved NDA/ANDA: Dietary supplements contains not listed on the label sibutramine, desmethylsibutramine and phenolphthalein based on FDA sampling.

ALL 50 STATES
Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
D-0664-2016
Lot/product code:
Lot # 000815004400; Exp 12/17
Recalling firm:
Life and More LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 16, 2015

Naturalyte Liquid Bicarbonate Concentrate 6.4 liter bottle A Dialysate Concentrate for Hemodialysis (liquid) Product Code: 08-4000-LB

Expansion of recall to lots manufactured in 2015 due to the potential for bacterial contamination.

ALL 50 STATES
Full report

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

Recall #:
71724
Lot/product code:
Lots begin with: 15AMLB, 15BMLB, 15CMLB.
Recalling firm:
Fresenius Medical Care Holdings, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 17, 2015

LYFO Disk

LYFO Disk Catalog #0983L is to contain Candida tropicalis. However, lot number 983-40-3 under Catalog #0983L, labeled as Candida tropicalis, is actually Yersinia entercolitica. This labeling error may cause a user's quality control to fail, resulting in testing needing to be repeated and delayed test results.

ALL 50 STATES
Full report

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

Recall #:
89513
Lot/product code:
Catalog Number 0983L, UDI: 10845357023930, Lot Number (Expiration Date): 983-40-3 (02/11/2016)
Recalling firm:
Microbiologics Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled August 25, 2015

1% Lidocaine HCl Injection, USP, 10 mg/mL, 30 mL Vial, Single-dose Preservative Free, Rx only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-4279-02

Presence of Particulate Matter: particulate matter identified as iron oxide, was found embedded in the neck of glass vials.

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-1815-2015
Lot/product code:
Lot #: 44-359-DK, Exp 08/01/2016
Recalling firm:
Hospira, Inc.
View official FDA record (opens in a new tab)
Class IHigh risk
DrugUndeclaredRecalled August 27, 2015

MIRACLE DIET 30 capsules, 30-count bottle, Manufactured Exclusively For: The One Minute Miracle Inc., UPC 7 538073516768.

Marketed Without An Approved NDA/ANDA: Miracle Diet 30 was found to contain not listed on the label phenolphthalein, a drug product once contained in over-the-counter laxatives but was taken off the U.S. market due to safety concerns, making this product an unapproved drug.

ALL 50 STATES
Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
D-0230-2016
Lot/product code:
All lots through Expiration Date 04/15/2018
Recalling firm:
The One Minute Miracle Inc
View official FDA record (opens in a new tab)
Class IHigh risk
DrugUndeclaredRecalled August 27, 2015

MIRACLE ROCK 48 capsules, packaged in 2 x 2-count blisters, 4-count capsules per carton, Manufactured Exclusively For: The One Minute Miracle Inc., UPC 0911312397354.

Marketed Without An Approved NDA/ANDA: Miracle Rock 48 was found to contain not listed on the label thiosildenafil, an analogue of an FDA approved drug for male erectile dysfunchtion making this product an unapproved drug.

ALL 50 STATES
Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
D-0229-2016
Lot/product code:
All lots through Expiration Date 06/01/2018
Recalling firm:
The One Minute Miracle Inc
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled September 29, 2015

Amidate (Etomidate Injection, USP), 40 mg/20 mL (2 mg/mL), LifeShield, 20 mL, Glass Abboject Syringe with male luer lock adapter, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-8060-29

Failed Impurities/Degradation Specifications: not meeting quality requirements(OOS) results for degradation product of etomidate was confirmed during stability testing.

ALL 50 STATES
Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0054-2016
Lot/product code:
Lot 34-531-DK, Exp 10/01/2015
Recalling firm:
Hospira Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 1, 2015

The "Pacifier Activated Lullaby" (PAL) System composed of three major components: 1) the PAL Player Module (aka Player Unit), 2) the PAL Pacifier Sensor, and 3) power supply. The system is designed to encourage and reinforce effective non-nutritive sucking of premature infants.

PAL unit has undergone significant technological changes since the previous 510(k) and labeling is not consistent with the cleared indications of the 510(k).

ALL 50 STATES
Full report

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

Recall #:
72436
Lot/product code:
Serial Numbers A1221, A1226 (Ship Date 07/2015);   Serial Numbers A1061, A1250, A1251 (Ship Date 05/2015);   Serial Number A1246 (Ship Date 04/2015);   Serial Numbers A1245, A1244, A1042, A1243 (Ship Date 02/2015);   Serial Number A1225 (Ship Date 01/2015);   Serial Numbers A1241, A1242 (Ship Date 12/2014);   Serial Number A1036 (Ship Date 11/2014);   Serial Numbers A1229, A1247, A1224 (Ship Date 10/2014);   Serial Numbers A1239, A1234, A1236, A1237, A1238, A1233, A1228, A1231, A1232, A1235 (Ship Date 09/2014);   Serial Number A1227 (Ship Date 08/2014);   Serial Number A1223 (Ship Date 07/2014);   Serial Numbers A1218, A1220 (Ship Date 06/2014);   Serial Numbers A1217, A1216, A1248 (Ship Date 04/2014);   Serial Numbers A1214, A1064 (Ship Date 03/2014);   Serial Numbers A1087, A1213 (Ship Date 01/2014);   Serial Numbers A1201, A1203, A1204, A1205, A1206, A1209, A1210, A1211, A1212, A1094, A1200, A1207, A1091, A1092, A1093, A1201 (Ship Date 12/2013;   Serial Numbers A1075, A1076, A1077, A1078, A1079, A1080, A1081, A1082, A1083, A1070, A1072, A1073, A1084, A1086, A1087, A1088, A1089, A1090, A1085 (Ship Date 11/2013);   Serial Numbers A1022, A1044 (Ship Date 10/2013);   Serial Number A1059 (Ship Date 09/2013);   Serial Numbers A1021, A1060, A1062, A1063, A1065, A1066, A1067, A1069 (Ship Date 08/2013);   Serial Numbers A1037, A1005, A1015, A1024, A1230, A1050, A1051, A1052, A1053, A1054, A1055, A1058, A1016, A1019, A1064, A1249 (Ship Date 07/2013);   Serial Numbers A1006, A1020, A1004, A1023, A1021 (Ship Date 05/2013);   Serial Numbers A1025, A1046, A1032 (Ship Date 04/2013);   Serial Numbers A1038, A1049, A1029, A1026, A1035, A1039, A1036, A1031, A1030, A1028, A1027, A1034 (Ship Date 03/2013);   Serial Number P11 (Ship Date 02/2013);   Serial Number P-7 (Ship Date 11/2012);   Serial Numbers A1013, P-8 (Ship Date 09/2012);   Serial Numbers A1043, P-6, A1041, P-9 (Ship Date 07/2012);
Recalling firm:
Powers Medical Devices, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled October 15, 2015

Repaskin 50 (octocrylene 7%, titanium dioxide 2%) Body Lotion Sunscreen gel cream, Broad Spectrum SPF 50, 6.8 fl oz (200 mL) tube, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0013-1, UPC 8 429979 415707

CGMP Deviations; product does not comply with manufacturing quality rules requirements

Full report

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

Recall #:
D-0844-2016
Lot/product code:
Lot code 41464901, exp 05/17
Recalling firm:
Sesderma, SL
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled October 15, 2015

Dryses Aluminum Chlorohydrate Deodorant for Men Roll-on, 2.5 fl oz (75 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0019-1 UPC 8 470002 075221

CGMP Deviations; product does not comply with manufacturing quality rules requirements

Full report

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

Recall #:
D-0846-2016
Lot/product code:
Lot code 40414701, exp 09/19; Lot code 33524701, exp 10/18; Lot code 40144101, exp 10/18
Recalling firm:
Sesderma, SL
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled October 15, 2015

Repaskin 50 (octocrylene 7%, titanium oxide 2%) Facial Sunscreen gel cream, Broad Spectrum SPF 50, 1.7 fl oz (50 mL) tube, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0011-1

CGMP Deviations; product does not comply with manufacturing quality rules requirements

Full report

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

Recall #:
D-0848-2016
Lot/product code:
Lot code 51594901, exp 06/18,
Recalling firm:
Sesderma, SL
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled October 15, 2015

Screenses Color Sunscreen Tinted facial make-up compact, Broad Spectrum SPF 50, Brown, 0.35 oz (10 g), Manufactured by Sesderma S.L., Valencia, Spain, UPC 8 429979 252166

CGMP Deviations; product does not comply with manufacturing quality rules requirements

Full report

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

Recall #:
D-0850-2016
Lot/product code:
Lot code H-04, exp 07/2019
Recalling firm:
Sesderma, SL
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled October 15, 2015

Repaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate 3%, octinoxate 3% Avobenzone 3%) Body Lotion Sunscreen gel cream, Broad Spectrum SPF 30, 6.8 fl oz (200 mL) tube, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0012-1 UPC8 429979 415691

CGMP Deviations; product does not comply with manufacturing quality rules requirements

Full report

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

Recall #:
D-0845-2016
Lot/product code:
Lot code 41274901, exp 2/19.
Recalling firm:
Sesderma, SL
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled October 15, 2015

Screenses Color Sunscreen, Tinted facial make-up compact, Broad Spectrum SPF 50 Light, 0.35 oz (10 g), Manufactured by Sesderma S.L., Valencia, Spain, UPC 8 429979 252159

CGMP Deviations; product does not comply with manufacturing quality rules requirements

Full report

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

Recall #:
D-0851-2016
Lot/product code:
Lot code H04.2, exp 11/2019
Recalling firm:
Sesderma, SL
View official FDA record (opens in a new tab)