Browse Drug Recalls
3,394 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 3,394 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 3,394 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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%, 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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%, 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% (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 | 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. |
| 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 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 | 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 | 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 | 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 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 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 | 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 | 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 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 4, 2022 | Alprazolam C-IV 1 mg 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical ... | CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufactu... | Class II | Direct Rx |
| Mar 4, 2022 | Alprazolam C-IV 2 mg, 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical... | CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufactu... | Class II | Direct Rx |
| Mar 3, 2022 | HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, Net contents: 1 U.S. Gallon/... | CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufac... | Class II | Tennessee Technical Coatings, Corp. |
| Mar 2, 2022 | Alprazolam Tablets, USP 1mg, 180-count bottles, Rx only, Manufactured by ULTR... | CGMP Deviation: Potential cross-contamination with other drug substance during the manufacturing ... | Class II | Golden State Medical Supply Inc. |
| Feb 22, 2022 | Alprazolam Tablets, USP 1mg, Generic for Xanax, Pkg Size: a) 30 tablets per b... | CGMP deviations | Class II | Preferred Pharmaceuticals, Inc. |
| Feb 18, 2022 | All Over-The-Counter (OTC) drug products sold by Family Dollar retail stores ... | CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center. | Class II | Dollar Tree Distribution, Inc. |
| Feb 16, 2022 | Olanzapine Tablets, USP 10 mg, 30-count bottles, Rx only, Manufactured for: M... | cGmp Deviations | Class II | Macleods Pharma Usa Inc |
| Feb 15, 2022 | Alprazolam Tablets, USP 2.0 mg, packaged in a) 100-count bottles (NDC 67253-9... | cGMP Deviations | Class II | ANI Pharmaceuticals, Inc. |
| Feb 15, 2022 | Alprazolam Tablets, USP 0.5 mg, packaged in a) 100-count bottles (NDC 67253-9... | cGMP Deviations | Class II | ANI Pharmaceuticals, Inc. |
| Feb 15, 2022 | Alprazolam Tablets, USP 0.25 mg, packaged in a) 100-count bottles (NDC 67253-... | cGMP Deviations | Class II | ANI Pharmaceuticals, Inc. |
| Feb 15, 2022 | Amlodipine and Olmesartan Medoxomil Tablets, 10 mg /20 mg, 30-count bottles, ... | cGMP deviations | Class II | Macleods Pharma Usa Inc |
| Feb 15, 2022 | Alprazolam Tablets, USP 1.0 mg, packaged in a) 100-count bottles (NDC 67253-9... | cGMP Deviations | Class II | ANI Pharmaceuticals, Inc. |
| Feb 15, 2022 | Pyrazinamide Tablets, USP 500 mg, 100-count bottles, Rx only, Manufactured by... | cGMP Deviations | Class II | ANI Pharmaceuticals, Inc. |
| Feb 4, 2022 | Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swab, 3.15% w/v an... | cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufa... | Class II | Professional Disposables International, 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.