Browse Drug Recalls

1,045 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,045 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 1,045 FDA drug recalls.

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DateProductReasonClassFirm
Apr 26, 2023 Tropicamide Ophthalmic Solution, USP 0.1%, 15 mL bottles, Rx only, Distribute... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Levofloxacin Ophthalmic Solution, 0.5%, 5 mL bottles, Rx Only, Manufactured b... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Clobetasol Propionate Cream, USP, 0.05%, packaged in a) 15g tubes, b) 30g tub... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Levofloxacin Injection 500mg/20 mL (25 mg/mL), For Intravenous Infusion, pack... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Feb 23, 2023 Clear Eyes, Once Daily, Eye Allergy Itch Relief, olopatadine hydrochloride op... Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained fo... Class II Teva Pharmaceuticals USA Inc
Feb 21, 2023 Evamist (estradiol transdermal spray), 1.53 mg of estradiol per spray, 0.27 f... Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Stan... Class III Padagis US LLC
Feb 15, 2023 Buprenorphine Transdermal System, CIII 10 mcg/hour, 4 Transdermal Systems One... Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydro... Class III AVEVA Drug Delivery Systems, Inc.
Feb 15, 2023 Buprenorphine Transdermal System, CIII 20 mcg/hour, 4 Transdermal Systems One... Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydro... Class III AVEVA Drug Delivery Systems, Inc.
Feb 2, 2023 Dermoplast FIRST AID ANTIBACTERIAL SPRAY (Benzethonium chloride 0.2% First ai... Subpotent Drug: Low assay observed in one of the two active ingredients during stability testing. Class III Advantice Health, Llc
Jan 30, 2023 Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The ... Failed Stability Specifications: Out of specification test results for viscosity was identified a... Class III Akorn, Inc.
Jan 20, 2023 Clobetasol propionate Cream USP, 0.05%, 45 g tube, Rx only, Manufactured for:... Subpotent Drug: Low assay result observed during long-term stability testing. Class III Lupin Pharmaceuticals Inc.
Jan 13, 2023 Diltiazem Hydrochloride Extended-Release Capsules, USP, 360 mg; Rx only; 90-c... Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and fai... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jan 4, 2023 SINUVA (mometasone furoate) sinus implant, 1350 mcg, 1 implant per pouch, Rx ... Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dis... Class III Intersect ENT, Inc.
Dec 27, 2022 Prochlorperazine Maleate Tablets, USP 5mg, 100 tablets, RX Only, Jubilant Cad... Subpotent Drug: Out of specification for assay at the 18-month stability timepoint. Class III Jubilant Cadista Pharmaceuticals, Inc.
Dec 21, 2022 Timolol Maleate Ophthalmic Solution, USP 0.5%, 2.5 mL, Rx Only, Mfg by: Apote... Failed Stability Specifications: Out of specification for weight loss at the 18-month stability t... Class III Apotex Corp.
Dec 12, 2022 Rifampin Capsules USP, 300 mg, 30-count bottle; Rx Only, Manufactured for: Lu... Failed Impurities/Degradation Specifications: Failure observed in related substance testing durin... Class II Lupin Pharmaceuticals Inc.
Nov 2, 2022 Moxifloxacin Ophthalmic Solution, 0.5%, 3 mL, Rx Only, Packaged and Distribut... cGMP deviation: discontinue of stability support for product. Class II Direct Rx
Oct 13, 2022 Fyarro (sirolimus protein-bound particles for injectable suspension (albumin-... Failed Stability Specifications Class III Aadi Bioscience
Sep 16, 2022 Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx... CGMP deviations: Out of specification results obtained during routine stability testing for ethan... Class II Novartis Pharmaceuticals Corporation
Sep 14, 2022 Phytonadione Injectable Emulsion USP, 10 mg/mL, 25x 1 mL single dose ampules ... Failed Stability Specifications: Out of specification results reported at 12-month stability test... Class III Dr. Reddy's Laboratories, Inc.
Aug 8, 2022 Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials,... Identification of an unknown impurity at the 12-month stability point. Further investigation has ... Class III Akorn, Inc
Jul 22, 2022 Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Rom... Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for... Class III Teva Pharmaceuticals USA Inc
Jul 7, 2022 Aripiprazole Tablets, USP 20 mg, packaged in a) 1,000-count bottle (NDC 6050... Failed dissolution specifications: OOS for dissolution at the 12-month stability time point. Class II Apotex Corp.
Jun 29, 2022 Testosterone Gel 1% (25mg testosterone/2.5g of gel) 2.5 g per unit dose, Rx O... Superpotent Drug: Out of specification assay result was obtained during stability testing. Class II Teva Pharmaceuticals USA Inc
Jun 27, 2022 Divalproex Sodium Delayed-Release Tablets, USP 500mg, Rx Only, 100 Tablets, D... Failed Dissolution Specifications: Failure occurred during routine stability testing of dissoluti... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jun 10, 2022 Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufac... Failed Dissolution Specifications: Out of specification test results observed in dissolution test... Class II Lupin Pharmaceuticals Inc.
Jun 9, 2022 Clonidine Transdermal System, USP 0.3 mg/day, 4 Patches (NDC 51862-455-01) pe... Defective Delivery System: Out of specification for release liner removal force results at the 3... Class II Mayne Pharma Inc
May 18, 2022 Alprostadil Injection USP 500 mcg/mL, 1 mL Single Dose Vial, 5 vials per Cart... Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtaine... Class III Teva Pharmaceuticals USA Inc
May 11, 2022 Anagrelide Capsules USP, 0.5 mg, 100-count bottles, Rx Only, Manufactured in... Failed Dissolution Specifications- Low Out-Of-Specification results obtained during stability tes... Class I Teva Pharmaceuticals USA Inc
Apr 27, 2022 GaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solut... Failed Stability Specification Class II Lupin Pharmaceuticals Inc.
Apr 21, 2022 Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented) (Potency expresse... CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Te... Class II McKesson Corporation dba McKesson Drug Company
Apr 21, 2022 Lidocaine Prilocaine Cream USP, 2.5%/2.5% Net Wt. 30 gram tube, Rx Only, Dist... CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Te... Class II McKesson Corporation dba McKesson Drug Company
Apr 21, 2022 Halobetasol Propionate Ointment 0.05% Net Wt., 50 gram tube, Rx Only, Manufac... CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Te... Class II McKesson Corporation dba McKesson Drug Company
Apr 21, 2022 Erythromycin Topical Gel USP, 2%, Net Wt 60 g tube, Rx only, Manufactured by:... CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Te... Class II McKesson Corporation dba McKesson Drug Company
Apr 21, 2022 Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL bottle, Rx ... CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Te... Class II McKesson Corporation dba McKesson Drug Company
Apr 7, 2022 Rifampin for Injection, USP, 600 mg/vial, One Vial per carton, Rx only, Manuf... Failed Impurities/Degradation Specifications: High out of specification results obtained for rela... Class II Mylan Pharmaceuticals Inc
Apr 1, 2022 Travoprost Ophthalmic Solution, USP, 0.004%, 2.5 mL bottle, Rx only, Manufact... Subpotent Drug and Failed Impurities/Degradation Specifications: low out-of-specification results... Class II Mylan Pharmaceuticals Inc
Mar 28, 2022 Preferred Pharmaceuticals, Inc. The Physician's Solution., Lansoprazole Delay... Out of specification results observed in dissolution during long term stability testing. Class II Preferred Pharmaceuticals, Inc.
Mar 24, 2022 Diclofenac Sodium Topical Solution 1.5% w/w, Generic for Pennsaid, 150 ml bot... CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Te... Class II Preferred Pharmaceuticals, Inc.
Mar 24, 2022 Econazole Nitrate Cream, 1%, Generic for Spectazole, 30 gm tube, Rx Only, Pre... CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Te... Class II Preferred Pharmaceuticals, Inc.
Mar 23, 2022 Lansoprazole Delayed-Release Capsules, USP, 15 mg, a) 30-count bottle, (NDC 5... Failed Dissolution Specifications; during long term stability testing. Class II Dr. Reddy's Laboratories, Inc.
Mar 23, 2022 Clobetasol Propionate Lotion 0.05%, Generic for Temovate, 118 mL bottle, Rx O... CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Te... Class II Preferred Pharmaceuticals, Inc.
Mar 23, 2022 Lansoprazole Delayed-Release Capsules, USP, 30 mg, 90-count bottle, Rx Only, ... Failed Dissolution Specifications; during long term stability testing. Class II Dr. Reddy's Laboratories, Inc.
Mar 18, 2022 NETSPOT (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate... Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability stud... Class III Advanced Accelerator Applications USA, Inc.
Mar 15, 2022 Gentamicin Sulfate Cream USP, 0.1%, packaged in 30 grams tubes, Rx Only, Manu... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Mar 15, 2022 Econazole Nitrate Cream, 1%, packaged in a) 15 grams tubes, NDC 52565-022-15;... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Mar 15, 2022 Fluocinonide Topical Solution USP, 0.05%, packaged in a) 20 mL bottles, NDC 5... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Mar 15, 2022 Fluocinonide Gel USP, 0.05%, packaged in a) 15 g tubes, NDC 52565-054-15; b) ... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Mar 15, 2022 Diflorasone Diacetate Ointment USP, 0.05%, Net Wt 60 g tubes, Rx only, Manufa... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Mar 15, 2022 Fluocinonide Cream USP, 0.1%, 120 grams tube, Rx Only, Manufactured by: Telig... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.

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.