Browse Drug Recalls
1,032 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,032 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 1,032 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| 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 | 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 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 | 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 | 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 | 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 | 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 | 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%, 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 | 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 | 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. |
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.