Browse Drug Recalls

18,008 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 18,008 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 18,008 FDA drug recalls.

DateProductReasonClassFirm
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 MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup, packag... CGMP Deviations: Failure to properly investigate failed microbial testing. Class II Plastikon Healthcare LLC
Mar 24, 2022 Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 ... CGMP Deviations: Failure to properly investigate failed microbial testing. Class II Plastikon Healthcare LLC
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 24, 2022 Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 ... Microbial Contamination of Non-Sterile Products Class I Plastikon Healthcare LLC
Mar 24, 2022 Acetaminophen Oral Solution, USP 650mg/ 20.3 mL cup, packaged in 10 cups per ... CGMP Deviations: Failure to properly investigate failed microbial testing. Class II Plastikon Healthcare LLC
Mar 24, 2022 MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup, packag... Microbial Contamination of Non-Sterile Products Class I Plastikon Healthcare LLC
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 23, 2022 TESTOSTERONE CYPIONATE *GS* Oil 200 MG/ML Injectable, Packaged in a multi dos... Lack of sterility assurance. Class II Drug Depot, Inc., dba APS Pharmacy
Mar 23, 2022 TESTOSTERONE CYPIONATE/ANASTROZOLE *GS* OIL 200MG/1MG/ML Injectable, Package... Lack of sterility assurance. Class II Drug Depot, Inc., dba APS Pharmacy
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 (CA) GONADORELIN (4ML) 0.2 MG/ML INJECTABLE, Packaged in a multi dose 10ML vi... Lack of sterility assurance. Class II Drug Depot, Inc., dba APS Pharmacy
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 TESTOSTERONE CYPIONATE *GS* (2 mL) 80 MG/ML Injectable, Packaged in a multi ... Lack of sterility assurance. Class II Drug Depot, Inc., dba APS Pharmacy
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 23, 2022 TESTOSTERONE CYPIONATE/PROPIONATE *SES* Oil (10 ML) 160MG/20MG/ML Injectable,... Lack of sterility assurance. Class II Drug Depot, Inc., dba APS Pharmacy
Mar 23, 2022 TESTOSTERONE CYPIONATE/ DHEA *GS* 200/10MG/ML Injectable, Packaged in a multi... Lack of sterility assurance. Class II Drug Depot, Inc., dba APS Pharmacy
Mar 23, 2022 GONADORELIN (5ML) 0.2 MG/ML INJECTABLE, Packaged in a multi dose 10ML vial, F... Lack of sterility assurance. Class II Drug Depot, Inc., dba APS Pharmacy
Mar 23, 2022 TESTOSTERONE CYPIONATE/ ANASTROZOLE *GS* OIL (10ML) 200MG/0.5MG/ML; Packaged ... Lack of sterility assurance. Class II Drug Depot, Inc., dba APS Pharmacy
Mar 21, 2022 The Natural Dentist Healthy Breath Antiseptic Rinse, Cool Mint, 16.9 FL OZ (5... Labeling; Label mix-up and Wrong Bar Code; back label incorrectly states active ingredient as Pep... Class II Revive Personal Products Company
Mar 21, 2022 SYMJEPI (epinephrine injection, USP) 0.15 mg (0.15 mg/0.3 mL), Two Pre-Filled... Defective Delivery System: Potential clogging of the needle preventing the dispensing of epinephr... Class I Adamis Pharmaceuticals Corporation
Mar 21, 2022 Accuretic (quinapril HCl/hydrochlorothiazide) tablets, 20 mg/12.5 mg*, 90 Tab... CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the accepta... Class II Pfizer Inc.
Mar 21, 2022 SYMJEPI (epinephrine injection, USP) 0.3 mg, (0.3 mg/0.3 mL), Two Pre-Filled ... Defective Delivery System: Potential clogging of the needle preventing the dispensing of epinephr... Class I Adamis Pharmaceuticals Corporation
Mar 21, 2022 quinapril and hydrochlorothiazide tablets, 20 mg/25 mg*, 90 Tablets bottles, ... CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the accepta... Class II Pfizer Inc.
Mar 21, 2022 quinapril HCl/hydrochlorothiazide tablets, 20 mg/12.5 mg*, 90 Tablets bottles... CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the accepta... Class II Pfizer Inc.
Mar 21, 2022 Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Table... CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit. Class II Sandoz, Inc
Mar 21, 2022 Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/12.5 mg, 90 tabl... CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the accepta... Class II Pfizer Inc.
Mar 21, 2022 Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/25 mg, 90 tablet... CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the accepta... Class II Pfizer Inc.
Mar 21, 2022 Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 10 mg/12.5 mg*, 90 Tab... CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the accepta... Class II Pfizer Inc.
Mar 21, 2022 Accuretic (quinapril HCl/hydrochlorothiazide) Tablets 10 mg/12.5 mg 90 tablet... CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the accepta... Class II Pfizer Inc.
Mar 21, 2022 quinapril HCl/hydrochlorothiazide tablets, 20 mg/25 mg*, 90 Tablets, Rx Only,... CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the accepta... Class II Pfizer 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 17, 2022 Glycopyrrolate Tablets, USP, 1 mg, 100-count bottle, Rx Only, Distributed by:... Presence of Foreign Substance: Complaint for pieces of glass discovered in a sealed bottle which ... Class II Aurolife Pharma, LLC
Mar 16, 2022 Enalapril Maleate Tablets, USP; 20 mg; 90 tablets, NDC 60429-186-90; manufact... CGMP Deviations Class II Golden State Medical Supply Inc.
Mar 16, 2022 Enalapril Maleate Tablets, USP; 5 mg; 90 tablets, NDC 60429-184-90; manufactu... CGMP Deviations Class II Golden State Medical Supply Inc.
Mar 16, 2022 Atorvstatin Calcium Tablets, USP 80 mg*, 90 Tablets, Rx Only, Mrd. By: Dr. Re... Failed Impurities/Degradation Specifications: Out of Specification results for related substance. Class III Dr. Reddy's Laboratories, Inc.
Mar 16, 2022 Enalapril Maleate Tablets, USP; 10 mg; 90 tablets, NDC 60429-185-90; manufact... CGMP Deviations Class II Golden State Medical Supply Inc.
Mar 16, 2022 Enalapril Maleate Tablets, USP; 2.5 mg; 90 tablets, NDC 60429-183-90; manufac... CGMP Deviations Class II Golden State Medical Supply Inc.
Mar 15, 2022 Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL (60 grams) bottle, Rx only,... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Mar 15, 2022 Clobetasol Propionate Cream USP, 0.05% (Emollient), packaged in a) 15 grams t... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Mar 15, 2022 Triamcinolone Acetonide Ointment USP, 0.5%, Net Wt. 15 grams tube, Rx Only, T... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Mar 15, 2022 Desoximetasone Ointment USP, 0.25%, packaged in a) 100 grams tubes, NDC 52565... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Mar 15, 2022 Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottle, ... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Mar 15, 2022 Lidocaine Cream, 4%, packaged in a) Net Wt. 15 grams tubes, NDC 52565-122-15;... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Mar 15, 2022 Halobetasol Propionate Ointment, 0.05%, packaged as a) 15 g tubes, NDC 52565-... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Mar 15, 2022 Triamcinolone Acetonide Cream USP, 0.1%, packaged in a) 15 grams tubes, NDC 5... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Mar 15, 2022 Gentamicin Sulfate Cream USP, 0.1%, packaged in a) 15 g tubes, NDC 52565-085-... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Mar 15, 2022 Hydrocortisone Butyrate Lotion, 0.1%, 4 fl oz (118 mL) bottle, Rx only, Manuf... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Mar 15, 2022 Lidocaine Ointment USP, 5%, Net Wt 35.44 g (1 1/4 Oz) tube, Rx Only, Manufact... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Mar 15, 2022 Desonide Ointment, 0.05%, packaged in a) 15 g tubes, NDC 52565-038-15; b) 60 ... 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.