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