UnclassifiedBacteria/virusAnnounced September 4, 2026
Foods Alive — Moringa Leaf Powder
Potential to be contaminated with Salmonella
Read FDA’s announcement (opens in a new tab)Recalls affecting South Dakota
Data last updated: September 6, 2026 at 10:21 PM UTC
16,210 recalls foundJust announced
Straight from FDA press releases — not yet formally classified or risk-gradedUnclassifiedAnnounced September 4, 2026
Business Pill, Branch Manager for Men — dietary supplements marketed for male sexual enhancement
Products contain undeclared yohimbine
Read FDA’s announcement (opens in a new tab)UnclassifiedBacteria/virusAnnounced September 3, 2026
Great Value — Organic Triple Berry Blend
Possible E. Coli Contamination
Read 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
Read 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
Read FDA’s announcement (opens in a new tab)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
Read FDA’s announcement (opens in a new tab)UnclassifiedAnnounced August 31, 2026
Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement
Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)
Read FDA’s announcement (opens in a new tab)UnclassifiedAllergenAnnounced August 31, 2026
Little Temptations — Chocolatey Eyeballs, 7 oz., 10 oz., 10.5 oz., 11 oz., and 16 oz.
Undeclared milk
Read FDA’s announcement (opens in a new tab)UnclassifiedBacteria/virusAnnounced August 29, 2026
Everything Sprouts — Robust Radish Mix, 5oz Cups
Potential to be contaminated with Shiga toxin-producing Escherichia coli (STEC) or Salmonella.
Read FDA’s announcement (opens in a new tab)UnclassifiedBacteria/virusAnnounced August 29, 2026
Martina — Mangoes
Potential contamination with Salmonella
Read FDA’s announcement (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.
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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.
Class IIILow risk
DrugRecalled February 2, 2016
Normosol-M and 5% Dextrose (multiple electrolytes and 5% dextrose) Injection Type 1, USP, 1000 mL Single-Dose Container bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7965-09, Barcode (01) 0 030409 796509 0.
Labeling: Incorrect or Missing Lot and/or Exp Date: Confirmed customer report of an incorrect expiration date printed on the primary container labeled "01AUG1017" rather than "01AUG2017".
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A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.
- Recall #:
- D-0727-2016
- Lot/product code:
- Lot #: 56-853-FW, Exp 01AUG2017
- Recalling firm:
- Hospira Inc.
Class IIILow risk
DrugRecalled March 15, 2016
Quelicin (Succinylcholine Chloride) Injection, USP 200 mg. (20 mg/mL), 10 mL Multiple-dose vial, packaged in 25 Unit vials per carton, Rx only, HOSPIRA, INC., LAKE FOREST, IL 60045 USA, NDC 0409-6629-02
Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for the lot number and/or expiration date to be faded or missing from the primary label on the glass vial.
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▸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-0836-2016
- Lot/product code:
- Lot 52-045-EV, Exp 07/1/2016
- Recalling firm:
- Hospira Inc.
Class IIILow risk
DrugRecalled March 23, 2016
Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20 mL Single-dose vial, packaged in 25 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2168-02, barcode (01) 2 030409 216802 5.
Failed pH Specifications: Confirmed high not meeting quality requirements (OOS) results for pH.
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▸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-0854-2016
- Lot/product code:
- Lot #: 42-335-DK, Exp 1JUN2016; 48-128-DK, 48-129-DK, 48-261-DK, 48-262-DK, 48-351-DK, Exp 1DEC2016; 52-361-DK, Exp 1APR2017; note that the lot number may be followed by numbers from 01 to 99.
- Recalling firm:
- Hospira Inc.
Class IIILow risk
DrugRecalled May 26, 2016
Remeven Cream, (50% Urea in a Cream Base), a) 5.0 oz (142 g) and b) 9.0 oz (255 g) tubes, Rx only, Manufactured by Sonar Products Inc, Carlstadt, NJ. Distributed by Stratus Pharmaceuticals Inc., Miami, FL.
Crystallization; Complaints that cream appears to have crystallized
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▸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-1464-2016
- Lot/product code:
- a) Lot (Exp): 8020 (02/17), 8096 (07/18), 8125 (08/18), 8169 (10/18). NDC 58980-680-50 b) Lot (Exp): 8020 (02/17), 8125 (08/18), 8170 (10/18). NDC 58980-680-90
- Recalling firm:
- Stratus Pharmaceuticals Inc
Class IIILow risk
DrugRecalled August 30, 2016
Ramipril Capsules, USP, 1.25 mg, 30-count bottle, Rx only, Manufactured by: Arrow Pharm (Malta) Ltd., Birzebbugia, BBG3000, Malta; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 16252-570-30.
Labeling: Incorrect or Missing Lot And/or Exp Date: Bottles labeled with the incorrect expiration date of 03/18 rather than 09/17.
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A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.
- Recall #:
- D-0118-2017
- Lot/product code:
- Lot #: 1136091A, Incorrectly Labeled Exp: 03/18
- Recalling firm:
- Actavis Laboratories, FL, Inc.
Class IIILow risk
DrugRecalled September 27, 2016
Gildess 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0,02 mg, USP), 21 count, (a) 3 blisters (NDC 0603-7607-48) and (b) 6 blisters (NDC 0603-7607-15), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL 35811
Weaker than it should be Drug; Ethinyl Estradiol
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-0120-2017
- Lot/product code:
- Lot Numbers (a) 4101059, 4101062, 4190536, 4265205, 4359294, 4501265, 4572326, 4651818, 4731571, 4798704 (b) 4187113, 4187114, 4187115, 4190273, 4190274, 4190280, 4265203, 4265204, 4359296, 4367922, 4379814, 4403535, 4403536, 4501267, 4506357, 4563352, 4563353, 4572327, 4572328, 4627845, 4731572, 4731573, 4798705, 4936585
- Recalling firm:
- Par Pharmaceutical, Inc.
Class IIILow risk
DrugRecalled September 27, 2016
Gildess 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP), 21 count, (a) 3 blisters (NDC 0603-7606-48) and (b) 6 blisters (NDC 0603-7606-15), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL 35811
Weaker than it should be Drug; Ethinyl Estradiol
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A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.
- Recall #:
- D-0119-2017
- Lot/product code:
- Lot Numbers (a) 4169949, 4297235, 4359298, 4501268, 4614353 (b) 4101064, 4196576, 4228443, 4265206, 4265207, 4267685, 4365281, 4365284, 4365289, 4501276, 4563354, 4563355, 4614354, 4731574, 4731575, 4793332, 4798708, 4798709
- Recalling firm:
- Par Pharmaceutical, Inc.
Class IIILow risk
DrugRecalled September 27, 2016
Gildess FE 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP and ferrous fumarate tablets, USP 75 mg), 6 blisters (28 count), NDC 0603-7608-17, Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL 35811
Weaker than it should be Drug; Ethinyl Estradiol
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-0122-2017
- Lot/product code:
- Lot Numbers: 4169952, 4169953, 4169954, 4185520, 4187127, 4190281, 4228446, 4258626, 4258627, 4279364, 4279365, 4279366, 4279369, 4359310, 4365283, 4365285, 4365286, 4365287, 4365288, 4379816, 4379817, 4479997, 4501273, 4501274, 4501275, 4563362, 4563363, 4563364, 4614359, 4614360, 4614361
- Recalling firm:
- Par Pharmaceutical, Inc.
Class IIILow risk
DrugRecalled September 27, 2016
Gildess 24 FE 1.5/30 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP and ferrous fumarate tablets, USP 75 mg), 28 count, (a) 3 blisters (NDC 0603-7610-49), and (b) 6 blisters (NDC 0603-7610-17), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL 35811
Weaker than it should be Drug; Ethinyl Estradiol
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-0123-2017
- Lot/product code:
- Lot Numbers (a) 4082018, 4082019, 4359320, 4461688, 4501285, 4501286 (b) 4028921, 4258629, 4359321, 4461689, 4501287, 4581736
- Recalling firm:
- Par Pharmaceutical, Inc.
Class IIILow risk
DrugRecalled September 27, 2016
Gildess FE 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP and ferrous fumarate tablets, USP 75 mg), 28 count, 6 blisters (NDC 0603-7609-17), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL 35811
Weaker than it should be Drug; Ethinyl Estradiol
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-0121-2017
- Lot/product code:
- Lot Numbers: 4101072, 4101073, 4101074, 4149704, 4152054, 4152056, 4152057, 4159857, 4169950, 4169951, 4187122, 4187123, 4187124, 4187125, 4190275, 4190276, 4190278, 4190279, 4265208, 4265209, 4265210, 4265211, 4265212, 4265213, 4265214, 4265215, 4265216, 4266535, 4266536, 4266537, 4266538, 4266539, 4267686, 4267687, 4267688, 4267689, 4329888, 4334997, 4334998, 4334999, 4359303, 4359304, 4359305, 4359306, 4359307, 4359308, 4362141, 4362142, 4362143, 4362144, 4362145, 4365282, 4367923, 4367924, 4367925, 4367926, 4367927, 4367928, 4367929, 4467392, 4467393, 4467394, 4467395, 4482870, 4487638, 4501269, 4501270, 4506358, 4563356, 4563357, 4563358, 4563359, 4563360, 4563361, 4572329, 4572331, 4572332, 4572333, 4583326, 4614355, 4614356, 4614357, 4615487, 4696445, 4696446, 4698118, 4731576, 4731577, 4731578, 4731579, 4731580, 4798710, 4798711, 4798712, 4798713
- Recalling firm:
- Par Pharmaceutical, Inc.
Class IIILow risk
DrugRecalled September 23, 2019
Ranitidine Tablets USP,150 mg, 8-count bottles, Distributed by: Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37073 Made in India NDC 55910-092-79
CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled because some bottles were empty.
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A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.
- Recall #:
- D-0166-2020
- Lot/product code:
- Lot #: NBSB19001DA3, Exp. date 02/2021
- Recalling firm:
- AuroMedics Pharma LLC
Class IIILow risk
DrugRecalled September 28, 2021
Butalbital, APAP, Caf 50/325/40 Tablets, packaged in a) 12-count bottles, NDC: 63629-8392-09, barcode 083929152151; b) 60-count bottles, NDC: 63629-8392-03, barcode 083923152614; c) 90-count bottles, NDC:63629-8392-04, barcode 083924152614, Lannett Company Inc; Rx only, Packaged by Bryant Ranch Prepack, Burbank, CA 91504.
Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label
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A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.
- Recall #:
- D-0256-2022
- Lot/product code:
- a) Lots: 152838, 152156, 152151, 151708, 151693, 151375, 151131, 151114, Exp: 7/31/2022, b) Lots: 152245, 151822, 151708, 151160, 151131, Exp: 7/31/2022, c) Lot #: 152614, Exp: 7/31/2022.
- Recalling firm:
- Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
Class IIILow risk
DrugRecalled September 28, 2021
Butalbital, APAP, Caf 50/325/40 Tablet, packaged in a) 12-count bottles, NDC: 71335-1767-09, barcode 083929164865; b) 20-count bottles, NDC: 71335-1767-01, barcode 083921157837; c) 30-count bottles, NDC: 71335-1767-02, barcode 083922165687, d) 60-count bottles, NDC: 71335-1767-03, barcode 083923153776, e) 90-count bottles, NDC: 71335-1767-04, barcode 083924152889, f) 120-count bottles, NDC: 71335-1767-07, barcode 083927153735. Westminster Pharmaceuticals LLC, Rx only, Packaged by Bryant Ranch Prepack, Burbank, CA 91504 USA
Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label
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▸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-0257-2022
- Lot/product code:
- a) Lots: 164865, Exp: 2/28/2021; 162113, Exp: 8/31/2022; 160419, Exp: 2/28/2023; 160004, 155752, 154380, 153776, 152889, Exp: 8/31/2022, b) Lots: 157837, 154997, Exp: 8/31/2022, c) Lots: 165687, 160419, 160330, Exp: 2/28/2023; 159973, 159943, 159352, 159345, 158841, 155752, 152347, Exp: 8/31/2022; 152245, 152156, 152197, 151338, 151160, Exp: 7/31/2022, d) Lots: 162641, Exp: 2/28/2023; 154380, 153776, 152889, Exp: 8/31/2022, e)Lots: 158841, 152889, Exp: 8/31/2022, f) Lots: 153776, 153735, 152347, Exp: 8/31/2022
- Recalling firm:
- Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
Class IIILow risk
DrugRecalled June 29, 2022
Aspirin and Extended-Release Dipyridamole Capsules, 25mg/200 mg, 60-count bottle, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-405-60.
Failed Tablet/Capsule Specification : Capsule breakage
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▸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-1282-2022
- Lot/product code:
- Lot#: 17201639, Exp 08/2022; 17201759, Exp 09/2022; 17202067, Exp 10/2022; 17210696, Exp 02/2023; 17210092, Exp 11/2022; 17210145, Exp 12/2022; 17210732, Exp 02/2023; 17211062, Exp 04/2023; 17211441, Exp 05/2023; 17211670, Exp 06/2023; 17211810, Exp 07/2023; 17211862, 17212020, 17212068, Exp 08/2023; 17212438, Exp 10/2023; 17220172, 17220251, Exp 12/2023.
- Recalling firm:
- Glenmark Pharmaceuticals Inc., USA
Class IIILow risk
DrugRecalled July 11, 2022
Tacrolimus Ointment, 0.1%, For Dermatological Use Only, Not for Ophthalmic Use, Rx Only, a) 30 g tube, NDC 68462-534-35, b) 60 g tube, NDC 68462-534-65, c) 100 g tube, NDC 68462-534-94, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India.
Defective Container: Tube split from side seam
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▸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-1304-2022
- Lot/product code:
- Lot #s: a) 15200058, 15200066, 15200067, Exp 06/2022; 15200075, Exp 07/2022; 15200094, Exp 08/2022; 15200119, 15200120, 15200122, Exp 09/2022; 15200131, 15200132, Exp 10/2022; 15200133, 15200134, 15200136, 15200139, Exp 11/2022; 15210033, 15210035, 15210036, 15210038 Exp 01/2023; 15210092, 15210094, 15210097, 15210099, Exp 03/2023; 15210100, 15210101, 15210104, Exp 04/2023; 15210122, Exp 05/2023; 15210148, 15210149, 15210153, 15210155, 15210157, 15210158, Exp 06/2023; 15210173, 15210174, 15210176, 15210177, 15210178, 15210179, Exp 07/2023; 15210184, 15210186, Exp 08/2023; 15210214, Exp 09/2023; 15210225, 15210226, 15210228, 15210230, 15210231, Exp 10/2023; 15220001, 15220002, Exp 12/2023. b) 15200092, Exp 08/2022; 15200114, 15200115, Exp 09/2022; 15200123, 15200124, Exp 10/2022; 15200142, 15200144, Exp 11/2022; 15210014, 15210015, 15210021, Exp 12/2022; 15210031, Exp 01/2023; 15210055, Exp 02/2023; 15210073, 15210075, Exp 03/2023; 15210117, 15210118, Exp 04/2023; 15210144, 15210147, 15210160, 15210162, Exp 06/2023; 15210171, Exp 07/2023; 15210187, 15210190, 15210191, 15210193, Exp 08/2023; 15210212, Exp 09/2023; 15210244, 15210247, Exp 11/2023; 15220007, Exp 12/2023; 15220019, 15220028, Exp 01/2024; 15220032, 15220034, 15220053, Exp 02/2024; 15220062, 15220064, 15220072, Exp 03/2024. c) 15200065, Exp 06/2022; 15200108, 15200109, Exp 09/2022; 15200125, Exp 10/2022; 15200148, 15200149, 15200150, Exp 11/2022; 15210007, 15210009, 15210012, 15210018, Exp 12/2022; 15210049, Exp 02/2023; 15210076, 15210077, 15210089, Exp 03/2023; 15210112, 15210114, Exp 04/2023; 15210124, 15210125, 15210127, Exp 05/2023; 15210169, 15210170, Exp 07/2023; 15210196, 15210199, Exp 08/2023; 15210204, 15210206, 15210207, 15210210, Exp 09/2023; 15210248, Exp 11/2023; 15220004, 15220013, 15220014, 15220015, Exp 12/2023; 15220025, 15220026, Exp 01/2024.
- Recalling firm:
- Glenmark Pharmaceuticals Inc., USA
Class IIILow risk
DrugRecalled August 8, 2022
Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials, Rx Only, Sterile, Manufactured for: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-189-24
Failed Impurities/Degradation Specifications: Identification of an unknown impurity at the 12-month stability point.
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-1471-2022
- Lot/product code:
- Lot #: 9N72, EXP 09/30/2022
- Recalling firm:
- Akorn, Inc
Class IIILow risk
DrugRecalled September 14, 2022
Phytonadione Injectable Emulsion USP, 10 mg/mL, 25x 1 mL single dose ampules per carton, Rx only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, NDC 43598-405-16
Failed Stability Specifications: not meeting quality requirements results reported at 12-month stability testing for aluminum content.
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-0007-2023
- Lot/product code:
- Lot # ACB101, Exp 03/2023
- Recalling firm:
- Dr. Reddy's Laboratories, Inc.
Class IIILow risk
DrugRecalled September 26, 2022
Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose vial, Rx Only, Distributed by: AuroMedics Pharma LLC E. Windsor, NJ 08520, Made in India, NDC 55150-188-10
Presence of Particulate Matter: Piece of metal found in a vial
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-1551-2022
- Lot/product code:
- Lot: CTA210006, Exp. 02/2024
- Recalling firm:
- AuroMedics Pharma LLC
Class IIILow risk
DrugRecalled January 30, 2023
Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, 2 mL bottle, Sterile, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. NDC: 17478-215-02
Failed Stability Specifications: not meeting quality requirements test results for viscosity was identified at the 12M stability timepoint.
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-0265-2023
- Lot/product code:
- Lot: 081031A, Exp 2/28/2023
- Recalling firm:
- Akorn, Inc.
Class IIILow risk
DrugRecalled February 21, 2023
Evamist (estradiol transdermal spray), 1.53 mg of estradiol per spray, 0.27 fl oz (8.1 mL) per metered-dose pump, Rx Only, Manufactured by DPT Laboratories, Ltd San Antonio, TX 78215, Manufactured for: Perrigo, Allegan, Minnapolis, MN 55427, NDC: 0574-2067-27
Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Standard Deviation did not meet the requirement at the 18-month stability time point.
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-0464-2023
- Lot/product code:
- Lot# SCDR, Exp 02/2024
- Recalling firm:
- Padagis US LLC
Class IIILow risk
DrugRecalled March 8, 2023
MEKTOVI (binimetinib) tablets, 15 mg, 180-count bottle, Rx only, Distributed by: Array BioPharma Inc., a wholly owned subsidiary of Pfizer Inc., Boulder, CO 80301. NDC: 70255-010-02
Labeling: Incorrect or Missing Lot and/or Exp Date: The carton and bottle labels state an expiry date of March 2026; the correct expiration date is February 2025.
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-0532-2023
- Lot/product code:
- Lot W054586A, EXP 03/2026
- Recalling firm:
- Pfizer Inc.
Class IIILow risk
DrugRecalled March 16, 2023
Epinephrine Professional EMS, Epinephrine Convenience Kit, Epinephrine 1 mg/mL, Rx Only, Focus Health Group, Manufactured for: Focus Health Group, 5802 Kingston Pike, Knoxville, TN 37919. Incorrect NDC (kit): 24357-011-13
Labeling; Incorrect NDC number on outer carton of product.
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-0535-2023
- Lot/product code:
- Lot numbers: 57943EMS, exp 5/31/2023; 56276EMS, exp 4/30/2024
- Recalling firm:
- Focus Health Group Inc
Class IIILow risk
DrugRecalled April 20, 2023
Lidocaine Patch 5%, 1 patch (63629-8755-20) packaged in 30-count patches per carton (63629-8755-1), Rx only, each patch contains: 700 mg (50mg per gram adhesive) in an aqueous base, Manufactured by: Actavis Laboratories UT, Inc., Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504 USA
Labeling: Typographical error on the upper left-hand side of the box and individual patch label that has the incorrect dosage form stating, each tablet contains instead of each adhesive patch contains.
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-0556-2023
- Lot/product code:
- Lot: 204603, Exp: 09/30/2024; Lots:208608, 208749, 208445, 209101, 208609, 208295, 209106, 209102, 209212, 208975, 209211, 209706, 209779, 209624, 209839, 209548, Exp: 12/31/2024; Lots: 204604, 204601, 204550, 204599, 204871, 204555, 205616, Exp: 11/30/2024; Lots: 205612, 204832, 205127, 204996, 205615, 205324, 205494, 205611, 206232, Exp: 10/31/2024.
- Recalling firm:
- Bryant Ranch Prepack, Inc.
Class IIILow risk
DrugRecalled June 13, 2023
Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-772-13
Failed Impurities/Degradation Specifications: not meeting quality requirements results obtained for conductivity.
ALL 50 STATES
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A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.
- Recall #:
- D-0875-2023
- Lot/product code:
- Lot: 44286 Exp. 02/2025
- Recalling firm:
- AVKARE LLC