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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.