Browse Drug Recalls

1,680 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,680 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 1,680 FDA drug recalls — Class III.

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Date	Product	Reason	Class	Firm
Mar 18, 2021	Sp-4, 100 mL solution bottles, Rx only, Washington Homeopathic Products, Inc....	An error occurred where the product was manufactured with Potassium Chloride instead of Potassium...	Class III	Washington Homeopathic Products, Inc.
Mar 18, 2021	Macula Pellets Homeopathic Medicine, 1 Oz bottles, Rx only, Manufactured for:...	An error occurred where the product was manufactured with Potassium Chloride instead of Potassium...	Class III	Washington Homeopathic Products, Inc.
Mar 18, 2021	LCL-2-0191, 5 gallon carboys, Rx only, Manufactured for: LaCore Labs, LLC, by...	An error occurred where the product was manufactured with Potassium Chloride instead of Potassium...	Class III	Washington Homeopathic Products, Inc.
Mar 9, 2021	Tremfya (guselkumab) Injection, 100 mg/mL, one single-dose prefilled syringe ...	Temperature Abuse	Class III	Cardinal Health Inc.
Mar 4, 2021	Romidepsin Injecton, 27.5 mg/5.5 mL (5 mg/mL) Rx Only, 5.5 ml vial, Teva Phar...	Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities...	Class III	Teva Pharmaceuticals USA
Mar 2, 2021	Menopur 75 IU, (menotropins for injection), packaged as a) 5 single dose vial...	Failed pH specifications: Out of Specification pH results for 0.9% Sodium Chloride, USP	Class III	Ferring Pharmaceuticals Inc
Feb 22, 2021	Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouche...	Subpotent	Class III	SUN PHARMACEUTICAL INDUSTRIES INC
Feb 19, 2021	Methylprednisolone Tablets USP, 4 MG, packaged in a 21-count blister pack, Rx...	Labeling: Illegible label: Customer complaint received of mis-alignment print of the printed dosi...	Class III	Jubilant Cadista Pharmaceuticals, Inc.
Feb 19, 2021	Atorvastatin Calcium Tablets, 40mg, packaged in a) 90-count bottles, NDC 5511...	Failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and...	Class III	Dr. Reddy's Laboratories, Inc.
Feb 17, 2021	Methacholine Challenge 5-Syringe Test Kits, Sterile Inhalation Solution, Pres...	Temperature Abuse; labeled with the incorrect room temperature (15-25 ¿C) storage conditions rath...	Class III	Edge Pharma, LLC
Feb 5, 2021	Pantoprazole Sodium for Injection 40mg/vial For I.V. infusion only Distribute...	Failed Impurity/Degradation Specifications	Class III	SUN PHARMACEUTICAL INDUSTRIES INC
Feb 2, 2021	Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 gr...	Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.	Class III	Teligent Pharma, Inc.
Feb 2, 2021	Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 g...	Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.	Class III	Teligent Pharma, Inc.
Feb 2, 2021	Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 50 gr...	Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.	Class III	Teligent Pharma, Inc.
Jan 29, 2021	Auryxia (ferric citrate) tablets, 210 mg*, 200 tablets bottle, RX ONLY, Manuf...	Failed Dissolution Specifications	Class III	Akebia Therapeutics dba Keryx Biopharmaceutials...
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 21, 2021	Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, 60 mL (usable volume afte...	Failed Impurities/Degradation Specifications; Out-of-specification test results observed for Impu...	Class III	Lupin Pharmaceuticals Inc.
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 11, 2021	Testosterone Cypionate Injection, USP CIII 200mg/ml FOR INTRAMUSCULAR USE ONL...	Incorrect Labeling: Incorrect lot number on secondary packaging	Class III	SUN PHARMACEUTICAL INDUSTRIES INC
Jan 7, 2021	Phytonadione Tablets 5mg, 30-count bottle, Rx Only, Manufactured For: Oceansi...	Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability t...	Class III	Bausch Health Companies, Inc.
Jan 7, 2021	Mephyton (phytonadione) Tablets 5mg, 100-count bottle, Rx Only, Manufactured ...	Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability t...	Class III	Bausch Health Companies, Inc.
Dec 23, 2020	Oxycodone Hydrochloride Oral Solution, USP 5 mg/5mL unit dose cups, Rx Only, ...	Presence of Foreign Substance: Particulate matter was found in multiple lots of product.	Class III	Genus Lifesciences Inc.
Dec 22, 2020	NDC 64380-721-06 TACROLIMUS CAPSULES, USP 1mg 100 Capsules Rx Only Manufactur...	Failed Moisture Limits	Class III	Strides Pharma Inc.
Dec 22, 2020	Epinephrine/Lidocaine HCl, Sterile Ophthalmic Solution for Injection, 0.8 mL ...	Labeling: Incorrect or Missing Lot and/or Exp Date	Class III	Edge Pharma, LLC
Dec 18, 2020	Benzhydrocodone and Acetaminophen Tablets, CII, 6.12mg/ 325mg, 100 Tablets, R...	Failed Impurities/Degradation Specifications; out of specification results obtained for N-Oxide i...	Class III	KVK-Tech, Inc.
Dec 17, 2020	Morphine Sulfate 3 mg/3 mL in 0.9% Sodium Chloride (1mg/mL) CII, Rx Only, 3 m...	Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra...	Class III	SCA Pharmaceuticals
Dec 16, 2020	Succinylcholine Chloride PF Inj. 200 mg/10 mL, 10 mL single use syringes, Rx ...	Labeling: Incorrect or Missing lot and/or expiration date: The lot number and BUD were printed in...	Class III	US Compounding Inc
Nov 25, 2020	Neostigmine Methylsulfate PF Inj. 5 mg/5 mL, 5 mL Single Use Syringes, Hospit...	Labelling: Missing label.	Class III	US Compounding Inc
Nov 20, 2020	Fentanyl, 250 mcg/ 5mL, Injection for IV or IM use, Rx only, SCA Pharmaceutic...	Subpotency: Out-of-specification stability test result for low potency was obtained.	Class III	SCA Pharmaceuticals
Nov 20, 2020	Scandonest 3% Plain (Mepivacaine Hydrochloride 3% without Vasoconstrictor), p...	Labeling: Label mix-up	Class III	Novocol Pharmaceutical of Canada, Inc.
Nov 17, 2020	DOXOrubicin Hydrochloride Injection, USP, 10 mg / 5 mL (2 mg / mL), 5 mL fill...	Cross Contamination with Other Products: trace amounts of octreotide found during testing	Class III	Fresenius Kabi USA, LLC
Nov 11, 2020	Levocetirizine Dihydrochloride Tablets, USP, 5 mg 30-count bottle, Rx Only, ...	Failed Impurities/Degradation Specifications: One lot of Levocetirizine dihydrochloride tablets 5...	Class III	InvaTech Pharma Solutions, LLC
Nov 11, 2020	Testosterone Gel 1%, 2.5 grams per unit dose, packaged in 2.5 gram Unit-Dose ...	Superpotent Drug: High out-of-specification assay results were obtained during stability testing.	Class III	Teva Pharmaceuticals USA
Nov 5, 2020	Clobetasol Propionate Ointment USP 0.05%, Net Wt. 50 grams, Rx Only, Teligent...	Superpotent and Subpotent; low and high assay results	Class III	Teligent Pharma, Inc.
Nov 3, 2020	Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL (60 grams) bottle, Rx Only,...	Subpotent Drug: One lot of Triamcinolone Acetonide Lotion, 0.025% 60 mL.does not meet assay results.	Class III	Teligent Pharma, Inc.
Oct 26, 2020	Olanzapine Orally Disintegrating Tablets, 5 mg, 30 count (3x10 unit dose) bli...	Subpotent	Class III	Jubilant Cadista Pharmaceuticals, Inc.
Oct 23, 2020	Felodipine Extended Release Tablets, USP 10 mg,100-count bottle, Rx only, Dis...	Failed impurities/ degradation specifications: Out of specification impurity results were observe...	Class III	Heritage Pharmaceuticals Inc
Oct 22, 2020	Fluent Children's Fever + Pain IBUPROFEN Oral Suspension USP 100 mg per 5 mL ...	Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension is missing dosing cups.	Class III	Aurobindo Pharma USA Inc.
Oct 9, 2020	Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet...	Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-m...	Class III	ANI Pharmaceuticals, Inc.
Oct 9, 2020	Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet...	Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-m...	Class III	ANI Pharmaceuticals, Inc.
Oct 9, 2020	Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet...	Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-m...	Class III	ANI Pharmaceuticals, Inc.
Oct 9, 2020	Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet...	Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-m...	Class III	ANI Pharmaceuticals, Inc.
Oct 9, 2020	Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet...	Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-m...	Class III	ANI Pharmaceuticals, Inc.
Oct 9, 2020	Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet...	Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-m...	Class III	ANI Pharmaceuticals, Inc.
Oct 6, 2020	Desflurane, USP Liquid for Inhalation, 240 mL, Rx Only, Manufactured by: Sha...	DEFECTIVE CONTAINER: Desflurane Liquid for Inhalation 240 mL may be leaking.	Class III	eVenus Pharmaceutical Laboratories
Oct 2, 2020	Candesartan Cilexetil and Hydrochlorothiazide Tablets, USP 32 mg/12.5 mg, pac...	Out-of-specification organic impurity results obtained during routine stability testing.	Class III	Mylan Pharmaceuticals Inc.
Sep 28, 2020	Fluocinonide Ointment USP 0.05%, packaged in: a) 15 gm tube, NDC 52565-0040-1...	Failed Impurities/Degradation - Out-of-specification results for Fluocinolone Acetonide impurity.	Class III	Teligent Pharma, Inc.
Sep 25, 2020	NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL Contains: Alcohol 0.5% v/v...	Failed Impurties/Degradation Specifications: out of specification results for an impurity for one...	Class III	VistaPharm, Inc.
Sep 24, 2020	Cystaran (cysteamine ophthalmic solution) 0.44%, For Ophthalmic Use Only, 15 ...	Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine...	Class III	Leadiant Biosciences, Inc.
Sep 24, 2020	Metformin Hydrochloride Tablets USP, 1000 mg, 60-count bottles, Rx Only, Man...	Presence of Foreign Tablets/Capsules: Metformin 1000mg with different imprint was found in bottles.	Class III	Legacy Pharmaceutical Packaging LLC

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.