Browse Drug Recalls

136 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 136 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 136 FDA drug recalls.

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DateProductReasonClassFirm
Mar 2, 2021 Acetaminophen, Extra Strength, Aspirin Free, 500 MG Tablets, 100-count bottle... Labeling: Label Mix-up; The bottle of over-the-counter Acetaminophen 500mg Extra Strength, 100 co... Class I A-S Medication Solutions LLC.
Feb 1, 2021 Scott¿ Moisturizing Foam Hand Sanitizer, 1.2 Liters (40.5 fl oz), Distributed... Labeling; Label Mix-up; some bottles containing Foam Skin Cleanser soap are incorrectly labeled a... Class II Kimberly-Clark Corporation
Jan 28, 2021 Glycopyrrolate Injection, USP 0.4 mg/2 mL (0.2 mg/mL) 25 x 2 mL Single Dose V... Labeling; Label Mix-up; correctly labeled 2 mL vials were packaged into blister strips labeled fo... Class III Accord Healthcare, Inc.
Jan 27, 2021 Cisatracurium Besylate Injection, USP, 10mg per 5mL (2 mg per mL), Single-Dos... Labeling: Label mix-up: Carton of Cisatracurium Besylate Injection, USP was observed to contain t... Class I Meitheal Pharmaceuticals Inc
Jan 27, 2021 Spironolactone Tablets, USP, 25 mg, packaged in: a) 30-count bottles (NDC 636... Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 25 mg may contain spironolact... Class I Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
Jan 27, 2021 Spironolactone Tablets, USP, 50 mg, packaged in 30-count bottles, Rx only, Ma... Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 50 mg may contain spironolact... Class II Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
Jan 15, 2021 Benzphetamine tablets, 50mg, CIII, repackaged in 30-count bottles, Distribute... Labeling: Label Mix-up: Bottle labeled as Benzonatate 100 mg capsules contained Benzphetamine 50 ... Class III Calvin Scott & Company, Inc.
Jan 15, 2021 Benzonatate capsules, 100mg, repackaged in 30-count bottles, Distributed by C... Labeling: Label Mix-up: Bottle labeled as Benzonatate 100 mg capsules contained Benzphetamine 50 ... Class I Calvin Scott & Company, Inc.
Jan 6, 2021 Sulfur Ointment 10%, Pomada de Azufre, 2.6 OZ (73.7g) jar; Manufactured by/ F... Labeling: Label Mix-Up. THe English label with Drug Facts panel for Camphor was incorrectly place... Class II DLC Laboratories, Inc
Dec 7, 2020 Sildenafil Tablets USP 100 mg, Rx Only, 100-count Bottle, Manufactured for: A... Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during b... Class II AVKARE Inc.
Dec 7, 2020 TraZODONE Hydrochloride Tablets USP 100 mg, Rx Only, 1000-count Bottle, Manuf... Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during b... Class I AVKARE Inc.
Nov 20, 2020 Scandonest 3% Plain (Mepivacaine Hydrochloride 3% without Vasoconstrictor), p... Labeling: Label mix-up Class III Novocol Pharmaceutical of Canada, Inc.
Aug 17, 2020 Amiodarone Hydrochloride Injection, USP, 450 mg/9 mL (50 mg/mL), 9 mL Single-... Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contai... Class I Mylan Institutional LLC
Aug 17, 2020 Tranexamic Acid Injection, USP, 1000 mg/10 mL (100 mg/mL), 10 mL Single-Dose ... Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contai... Class I Mylan Institutional LLC
Apr 20, 2020 Lisinopril Tablets USP, 20 mg, 1000-count bottle, Rx Only, Manufactured for: ... Product Mix-Up: a complaint received indicating mix-up of 10 mg Lisinopril tablets inside of 2 se... Class II Lupin Pharmaceuticals Inc.
Apr 1, 2020 Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx only, Manufactured for: L... Presence of Foreign Tablet/ Capsule: Product complaint received indicating mix-up of one lisinopr... Class II Lupin Pharmaceuticals Inc.
Mar 2, 2020 Carbidopa and Levodopa Tablets, USP 25 mg/250mg, 100 ct bottle, Rx Only, Mayn... Product Mix-Up: A foreign tablet was found in bottle. Class II Mayne Pharma Inc
Nov 15, 2019 Colostat, Homeopathic Remedy, 1 fl. oz. (30 mL) per bottle, 20% Ethanol, Dist... Labeling mix-up - Indications on product label are incorrect. Class III Grato Holdings, Inc.
Nov 15, 2019 Timolol Maleate Sterile Opthalmic Solution,USP 0.25%, 5 mL, Rx Only, For Topi... Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had... Class III Rising Pharmaceuticals, Inc.
Nov 15, 2019 Timolol Maleate USP, 0.5%, 5 mL, Sterile Opthalmic Solution, Rx Only, For T... Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had... Class III Rising Pharmaceuticals, Inc.
Sep 27, 2019 Testosterone Cypionate Injection, USP, 2000 mg/10 mL, 1 mL Vial, Single-Dose,... Labeling:Label Mix-up: Shipper Carton labelled Testosterone Cypionate Injection, USP, 200mg/mL, 1... Class III Arbor Pharmaceuticals Inc.
Sep 6, 2019 Quinacrine Dihydrochloride (98.25%), bulk API product, packaged in a) 500 g N... Label Mix-Up: Product labeled as Quinacrine Dihydrochloride; however, after testing, identified a... Class I Darmerica, LLC
Jun 7, 2019 Myorisan (isotretinoin capsules, USP), 40 mg, packaged in cartons of 30 Capsu... Labeling: Label mix-up: Product secondary carton erroneously states 40mg instead of 30 mg, primar... Class III Akorn Inc
May 13, 2019 Amitiza (lubiprostone) capsules, 24 mcg, 60-count bottle, Rx only, Manufactur... Labeling: Label mix-up. Amitiza 8 mcg capsules are being recalled because 24 mcg capsules were fo... Class II MALLINCKRODT PHARMACEUTICALS
May 13, 2019 Amitiza (lubiprostone) capsules, 8 mcg, 60-count bottle, Rx only, Manufacture... Labeling: Label mix-up. Amitiza 8 mcg capsules are being recalled because 24 mcg capsules were fo... Class II MALLINCKRODT PHARMACEUTICALS
Apr 25, 2019 Carvedilol Tablets, USP, 6.25 mg, 500 count bottles, Rx Only Manufactured by:... Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg act... Class II Zydus Pharmaceuticals USA Inc
Apr 25, 2019 Acyclovir Tablets, USP, 400 mg, 100 count bottles, Rx Only Manufactured by: C... Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg act... Class II Zydus Pharmaceuticals USA Inc
Apr 19, 2019 FENTANYL Transdermal System, 12 mcg/h, five (12 mcg/h) systems per carton, Rx... Product Mix-Up: Customer complaint that their carton labeled as Fentanyl Transdermal Systems, 12 ... Class I Alvogen, Inc
Jan 16, 2019 NORepinephrine 4 mg added to 5% Dextrose 250 mL Bag (PF), 4 mg / 250 mL, 250 ... Labeling: Label mix-up Class II KRS Global Biotechnology, Inc
Jan 16, 2019 NORepinephrine 16 mg added to 0.9% Sodium Chloride (PF), 16 mg / 250 mL, 250 ... Labeling: Label mix-up Class II KRS Global Biotechnology, Inc
Jan 16, 2019 Docusate Sodium, 100mg softgels, packaged in 10 x 10 unit dose blister cards,... Labeling: Label mix-up: Secondary carton may be labeled as Gabapentin 300mg instead of Docusate S... Class II Rx Pak Division of McKesson Corporation
Nov 9, 2018 Medi-Stat Foam, Antimicrobial Hand Soap, Chloroxylenol 0.5%, 1250 mL (42.3 fl... Labeling: Label mix-up - the label on the product may not match the formula in the bottle. Class II Ecolab Inc
Nov 9, 2018 Equi-Soft Foam, Antimicrobial Hand Soap, 0.55% Benzalkonium Chloride, 25 fl o... Labeling: Label mix-up - the label on the product may not match the formula in the bottle. Class II Ecolab Inc
Aug 21, 2018 Hydrochlorothiazide Tablets USP, 12.5 mg, 100-count bottle, Rx Only, Manufact... Product Mix-Up: customer complaint that a sealed bottle labeled as Hydrochlorothiazide Tablets US... Class I Accord Healthcare, Inc.
Aug 15, 2018 Montelukast Sodium Tablets 10 mg, 30-count bottle, Rx Only, By: Hetero Hetero... Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 ... Class I Hetero Labs Limited Unit V
Apr 20, 2018 Diclofenac Sodium and Misoprostol Delayed Release Tablets 75 mg/0.2 mg, 60-co... Labeling: Label Mix-Up: bottle labeled as Diclofenac Sodium and Misoprostol 75 mg/0.2 mg containe... Class II Exela Pharma Sciences LLC
Mar 15, 2018 All Alka-Seltzer Plus¿ packages with a full front panel instant Redeemable Co... Labeling: Label Mix-Up: Bayer is recalling all Alka-Seltzer Plus packages, with a green or orange... Class I Bayer HealthCare Pharmaceuticals, Inc.
Mar 5, 2018 Brilliant Blue G for Intraocular Injection 0.5mL vial 0.25 mg/mL Compounded ... Labeling: Label Mix-Up: Brilliant Blue G was labeled with an inaccurate auxiliary label which con... Class III Pine Pharmaceuticals, LLC
Feb 23, 2018 Coppertone Kids Sunscreen Spray (avobenzone 3%, Homosalate 10%, Octisalate 5%... Labeling: Label mix-up Class II Bayer HealthCare Pharmaceuticals, Inc.
Feb 21, 2018 Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 10... Labeling: Label mix-up - A complaint was received of one bag of Fluconazole Injection, Iso-Osmoti... Class II Renaissance Lakewood, LLC
Jan 17, 2018 Senna Laxative (sennosides) tablets, 8.6 mg, 100-count bottles, Manufactured ... Labeling: Label Mix-Up: Customer complaint received that a bottle labeled as Senna Laxative conta... Class I Magno Humphries Laboratories, Inc
Jan 4, 2018 Clopidogrel Tablets, USP 75 mg, 30-count bottles, Rx only, Packaged for: In... LABELING: LABEL MIX-UP. Simvastatin tablets, USP 10 mg were found in bottles labeled as Clopidogr... Class I International Laboratories, LLC
Dec 4, 2017 Gabapentin Tablets, USP, 800 mg, 500-count, Rx only, Made in India, PONDRUGS/... Labeling: Label Mix-Up.some bottles labeled as Gabapentin 800 mg contain Gabapentin 600 mg Class II Solco Healtcare US LLC
Oct 27, 2017 Midazolam Injection, USP, Preservative Free, 2 mg / 2 mL (1 mg / mL), 24 X 2m... Labeling: Label MIX-UP. Blister Packages, Labeled as Midazolam injection, USP, 2 mg / 2 ml, Cont... Class I Fresenius Kabi USA, LLC
Aug 7, 2017 Pravastatin Sodium Tablets, USP, 40 mg, 30-count bottle, Rx only, Packaged fo... Labeling: Label mix-up, the product labeled as Pravastatin sodium tablets 40 mg was filled with B... Class I International Laboratories, Inc.
Aug 4, 2017 Povidone Iodine, USP Prep Solution, 10%, packaged in 1 gallon bottle, OTC, Ma... Labeling: Label mix-up. Finished product Povidone iodine 7.5% was labeled as Povidone iodine 10% ... Class II Degasa Sa De Cv
Jul 5, 2017 Carbamazepine Oral Suspension, USP. 100 mg/5 mL, 5 mL Unit Dose Cups, Rx Only... Labeling Error: Label mix-up. Products' unit dose cups are correctly labeled, but the product ca... Class II Precision Dose Inc.
Jun 5, 2017 EliquisTablets 5mg, 60 count bottle, Rx Only, Marketed by: Bristol-Meyers Squ... Labeling: Label Mix-up: One bottle of Eliquis 5 mg tablet was found to contain lower-strength Eli... Class I Bristol-myers Squibb Company
Jun 5, 2017 Walgreens Daytime and Nighttime Cold & Flu, packaged in combo pack of two pla... Labeling: Label Mix-Up - This product is being recalled due to an incorrect product sleeve on the... Class III L. Perrigo Company
Sep 8, 2016 Lansoprazole Delayed-Release Capsules, USP, 30 mg, packaged in 100-count cart... Labeling: Label mix-up. The inner packaging was properly labeled Omeprazole DR 40mg Capsules, but... Class III Mckesson Packaging Services

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.