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 15, 2022 Clobetasol Propionate Cream USP, 0.05%, packaged in a) 15 grams tube, NDC 525... 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%, Net Wt. 50 grams tube, 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 Triamcinolone Acetonide Ointment USP, 0.1%, packaged in a) 15 grams tubes, ND... 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, Teligent... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Mar 15, 2022 Gentamicin Sulfate Ointment USP 0.1%, packaged as a) 15 grams tube, NDC 52565... 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%, Net Wt. 30 grams tube, Distributed by: RUGBY LABORATORIES... 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 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 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 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 Halobetasol Propionate Ointment, 0.05%, Net Wt. 50 grams tube, 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 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 Hydrocortisone Butyrate Lotion, 0.1%, packaged in a) 2 fl oz (59 mL) bottles,... 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 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 Desoximetasone Ointment USP, 0.05%, 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 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.
Mar 15, 2022 Nystatin and Triamcinolone Acetonide Ointment, USP, 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 Desoximetasone Ointment USP, 0.05%, Net Wt. 100 grams tubes, Rx only, Manufac... 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, Dist... 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%, packaged in 60 grams tube, Rx only, M... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Mar 15, 2022 Clobetasol Propionate Ointment USP, 0.05%, packaged in a) 15 grams tube, NDC ... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Mar 15, 2022 Clobetasol Propionate Gel, 0.05%, packaged in a) 15 grams tube, NDC 52565-082... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Mar 15, 2022 Clobetasol Propionate Lotion, 0.05%, packaged in a) 2 fl. oz. (59 mL) bottles... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Mar 15, 2022 Betamethasone Dipropionate Lotion USP, 0.05%* (Augmented), packaged in a) 30 ... 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) bottles,... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Mar 14, 2022 Norepinephrine Bitartrate Injection 4mg per 250 mL in 0.9% Sodium Chloride, 4... Defective container Class II Athenex Pharma Solutions, LLC
Mar 14, 2022 PAPAVERINE HYDROCHLORIDE Injection, USP, 60 mg/2mL (30 mg/mL), packaged as a)... Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that ... Class II Vitae Enim Vitae Scientific, Inc.
Mar 14, 2022 TETRACAINE 1% Tetracaine HCI Injection, USP, 20mg/2mL (10mg/mL), 10 x 2ml Sin... Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that ... Class II Vitae Enim Vitae Scientific, Inc.
Mar 14, 2022 Phenylephrine HCl Injection 40 mg per 250 mL in 0.9% Sodium Chloride, 40 mg, ... Defective container Class II Athenex Pharma Solutions, LLC
Mar 14, 2022 Phenylephrine HCl Injection 50 mg per 250 mL in 0.9% Sodium Chloride, 50 mg, ... Defective container Class II Athenex Pharma Solutions, LLC
Mar 14, 2022 Phenylephrine HCl Injection in 0.9% Sodium Chloride, 20 mg, 250 mL excel bag,... Defective container Class II Athenex Pharma Solutions, LLC
Mar 14, 2022 PHENOBARBITAL Sodium Injection, USP, 130 mg/mL, packaged as a) 25 x 1 mL Vial... Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that ... Class II Vitae Enim Vitae Scientific, Inc.
Mar 14, 2022 Epinephrine Injection 8 mg per 250 mL in 0.9% Sodium Chloride, 8mg, 250 mL ex... Defective container Class II Athenex Pharma Solutions, LLC
Mar 14, 2022 PHENOBARBITAL Sodium Injection, USP, 65mg/mL, packaged as a) 25 x 1 mL Vials ... Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that ... Class II Vitae Enim Vitae Scientific, Inc.
Mar 14, 2022 Norepinephrine Bitartrate Injection 16 mg per 250 mL added to 0.9% Sodium Chl... Defective container Class II Athenex Pharma Solutions, LLC
Mar 14, 2022 Norepinephrine Bitartrate Injection 8 mg per 250 mL in 0.9% Sodium Chloride, ... Defective container Class II Athenex Pharma Solutions, LLC
Mar 11, 2022 Sucralfate Oral Suspension, USP 1g/10mL, packaged in a) 40 case of 10 mL unit... Labeling: Label Mix-Up Class II DASH Pharmaceuticals LLC
Mar 10, 2022 Risedronate Sodium Tablets, USP, 5 mg, Rx Only, 30-count bottle, Manufactured... FAILED CONTENT UNIFORMITY SPECIFICATIONS Class III Macleods Pharma Usa Inc
Mar 10, 2022 ROCK TOWN - DISTILLERY - HAND SANITIZER, Alcohol Antiseptic 70%, Topical Solu... CGMP Deviations: FDA analysis found product to contain acetal and acetaldehyde above specificatio... Class II Rock Town Distillery, Inc.
Mar 8, 2022 Hydroxocobalamin B12 1mg/mL, Multi-Dose 30 mL vial, Each ML contains: 0.82% S... Sub Potent Class III Olympia Compounding Pharmacy dba Olympia Pharmacy
Mar 8, 2022 Meclizine Hydrochloride Tablets USP, 12.5 mg, packaged in a case of 24 bottle... Labeling: Label mix-up: Incorrect label placed on product. Shipper cases labeled Meclizine Hydroc... Class I Jubilant Cadista Pharmaceuticals, Inc.
Mar 8, 2022 Sermorelin Acetate Lyophilized powder for reconstitution, Multi-Dose 9 mg per... Sub Potent Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Mar 8, 2022 Sincalide Lyophilized powder for reconstitution Each ML contains: Mannitol 17... Super Potent and Failed Reconstitution Time Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Mar 8, 2022 T-105, Papaverine 30 mg/mL Phentolamine 1 mg/mL PGE 10 mcg/mL packaged as a) ... Super Potent Class III Olympia Compounding Pharmacy dba Olympia Pharmacy
Mar 8, 2022 NAD+ Nicotinamide Adenine Dinucleotide, Lyophilized powder for reconstitution... Product found to be Sub Potent or Exceeded reconstitution time Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Mar 8, 2022 Formula F9, Papaverine 0.9 mg/mL, Phentolamine 0.1 mg/mL, PGE 20 mcg/mL, Atro... Sub Potent Class III Olympia Compounding Pharmacy dba Olympia Pharmacy
Mar 8, 2022 SB-4, Papaverine 30mg/mL, Phentolamine 3mg/mL, Alprostadil 40mcg/mL, packaged... Sub Potent Class III Olympia Compounding Pharmacy dba Olympia Pharmacy
Mar 7, 2022 Biotin 5mg/mL, 5mL-vial, Refrigerate, Tailor Made Compounding Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Hydroxocobalamin Preservative Free 5mg/mL, 1mL-vial, Refrigerate, Tailor Made... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Hydroxocobalamin 25mg/mL, 10mL-vial, Room Temperature, Tailor Made Compounding Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding

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.