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 |
|---|---|---|---|---|
| May 27, 2026 | Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, Di... | Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolutio... | Class II | Lannett Company Inc. |
| May 18, 2026 | PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Ste... | Failed Stability Specifications | Class III | AbbVie Inc. |
| May 14, 2026 | Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distribu... | Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, ex... | Class III | AVEVA Drug Delivery Systems, Inc. |
| Apr 29, 2026 | Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by... | CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 pp... | Class II | Ajanta Pharma Ltd. |
| Apr 29, 2026 | Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by... | CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 pp... | Class II | Ajanta Pharma Ltd. |
| Apr 29, 2026 | Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 2724... | CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 pp... | Class II | Ajanta Pharma Ltd. |
| Apr 9, 2026 | Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit d... | Failed Capsule Specifications: Out of specification results obtained during routine stability tes... | Class II | The Harvard Drug Group LLC |
| Apr 1, 2026 | Blemish Spot Treatment (Salicylic Acid) 1%, .5 fl oz (15 ml) bottles, Skin Sc... | Failed Stability Specifications | Class II | Island Kinetics, Inc. d.b.a. CoValence Laborato... |
| Mar 25, 2026 | Fluocinonide, USP, 0.05% Cream, 15g tube, Rx only, Mfd by: Taro Pharmaceutica... | Failed Viscosity Specifications: Out of Specification results, above the specification limit, in... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Mar 25, 2026 | Fluocinonide, USP, 0.05% Cream, 60g tube, Rx only, Mfd by: Taro Pharmaceutica... | Failed Viscosity Specifications: Out of Specification results, above the specification limit, in... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Mar 25, 2026 | Fluocinonide, USP, 0.05% Cream, 30g tube, Rx only, Mfd by: Taro Pharmaceutica... | Failed Viscosity Specifications: Out of Specification results, above the specification limit, in... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Mar 19, 2026 | traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manu... | Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was f... | Class II | Amneal Pharmaceuticals, LLC |
| Mar 3, 2026 | Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx ... | Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-... | Class II | Rising Pharma Holding, Inc. |
| Feb 18, 2026 | Nilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, Manufac... | Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condit... | Class III | Cipla USA, Inc. |
| Feb 18, 2026 | MAXIMUM, ZONE 1, 4% Lidocaine Cream, 1/2 oz bottles, Distributed By: Dermal S... | Stability Data Does Not Support Expiry Date. | Class II | HTO Nevada Inc. dba Kirkman |
| Feb 18, 2026 | MAXIMUM, ZONE 2, 4% Lidocaine Cream, (Lidocaine 4% and Epinephrine 0.01%), 1... | Stability Data Does Not Support Expiry Date. | Class II | HTO Nevada Inc. dba Kirkman |
| Feb 18, 2026 | FIVE-STAR, VASOCAINE Spray, (Lidocaine HCl 4%, Racepinephrine HCl 0.01%), 4oz... | Stability Data Does Not Support Expiry Date. | Class II | HTO Nevada Inc. dba Kirkman |
| Feb 18, 2026 | Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufac... | Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condit... | Class III | Cipla USA, Inc. |
| Feb 4, 2026 | Dexamethasone Sodium Phosphate Injection, USP, 100 mg/ 10 mL, (10 mg/mL), 10x... | Failed Impurities/Degradation Specifications - OOS impurities result observed during long term st... | Class II | SOMERSET THERAPEUTICS LLC |
| Nov 26, 2025 | Cisatracurium Besylate Injection USP, 10 mg/5 mL* (2mg/mL), 10 x 5 mL Single-... | Subpotent product:out of specification assay results observed during long term stability testing. | Class III | SOMERSET THERAPEUTICS LLC |
| Nov 26, 2025 | Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL), 10 x 20 mL Single... | Subpotent product:out of specification assay results observed during long term stability testing. | Class III | SOMERSET THERAPEUTICS LLC |
| Nov 26, 2025 | Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL), 10 x 10 mL Mult... | Subpotent product:out of specification assay results observed during long term stability testing. | Class III | SOMERSET THERAPEUTICS LLC |
| Nov 11, 2025 | Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Labor... | Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lo... | Class III | Dr. Reddy's Laboratories, Inc. |
| Oct 31, 2025 | Phytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carto... | Failed Stability Specifications: Observed OOS results: eg results for colour index | Class II | Cipla Limited |
| Oct 28, 2025 | Lisdexamfetamine Dimesylate Capsules, 30 mg, CII, 100-count bottle, Rx only, ... | Failed Dissolution Specifications: An out of specification results observed in dissolution test d... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Oct 28, 2025 | Lisdexamfetamine Dimesylate Capsules, 40 mg, CII, 100-count bottle, Rx only, ... | Failed Dissolution Specifications: An out of specification results observed in dissolution test d... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Oct 28, 2025 | Lisdexamfetamine Dimesylate Capsules, 10 mg, CII, 100-count bottle, Rx only, ... | Failed Dissolution Specifications: An out of specification results observed in dissolution test d... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Oct 28, 2025 | Lisdexamfetamine Dimesylate Capsules, 20 mg, CII, 100-count bottle, Rx only, ... | Failed Dissolution Specifications: An out of specification results observed in dissolution test d... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Oct 28, 2025 | Lisdexamfetamine Dimesylate Capsules, 70 mg, CII, 100-count bottle, Rx only, ... | Failed Dissolution Specifications: An out of specification results observed in dissolution test d... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Oct 28, 2025 | Lisdexamfetamine Dimesylate Capsules, 50 mg, CII, 100-count bottle, Rx only, ... | Failed Dissolution Specifications: An out of specification results observed in dissolution test d... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Oct 28, 2025 | Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottle, Rx only, ... | Failed Dissolution Specifications: An out of specification results observed in dissolution test d... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Oct 24, 2025 | Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack ... | Failed stability specifications: Out of specification for hardness test | Class II | Cipla USA, Inc. |
| Oct 24, 2025 | Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack ... | Failed stability specifications: Out of specification for hardness test | Class II | Cipla USA, Inc. |
| Oct 10, 2025 | Gabapentin Capsules, USP, 100 mg, 100 Capsules (10 x 10 blister packs), Rx on... | Failed Impurities/Degradation Specifications: an out of specification result obtained during rout... | Class II | The Harvard Drug Group LLC |
| Oct 10, 2025 | Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only,... | Failed Impurities/Degradation Specifications: an out of specification result obtained during rout... | Class II | The Harvard Drug Group LLC |
| Sep 29, 2025 | Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only, Distribu... | Failed dissolution specifications: Stability testing found that the lot did not meet dissolution ... | Class II | Acella Pharmaceuticals, LLC |
| Sep 26, 2025 | Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 25 x 10 mL ... | Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative co... | Class II | Dr. Reddy's Laboratories, Inc. |
| Sep 16, 2025 | Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, ... | Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the... | Class II | ACCORD HEALTHCARE, INC. |
| Aug 8, 2025 | Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manuf... | Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by ... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Jul 24, 2025 | Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET C... | Failed Stability Specifications: Out of specification results was observed in Induction Port duri... | Class III | Cipla USA, Inc. |
| Jul 9, 2025 | Epinephrine Lidocaine HCL, 0.25mg/mL and 7.5 mg/mL, 20x1 mL Vials per carton,... | Sub-Potent Drug: Subpotent assay results during stability testing. | Class II | Imprimis NJOF, LLC |
| Jul 9, 2025 | Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution... | Sub-Potent Drug: Subpotent assay results during stability testing. | Class III | Imprimis NJOF, LLC |
| Jun 24, 2025 | Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Packaged in a) 100... | Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the ... | Class II | Granules Pharmaceuticals Inc. |
| Jun 16, 2025 | Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottles, Rx only,... | Failed Dissolution Specifications: An out of specification results observed in dissolution test d... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| May 29, 2025 | Gentamicin Injection, USP, (PEDIATRIC), 20 mg per 2 mL (10 mg per mL*), 2 mL ... | Failed Stability Specifications: Out of specification results for the Color Absorbance test duri... | Class II | Eugia US LLC |
| May 23, 2025 | Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 100 mL (when mixed), Rx... | Failed Impurities/Degradation Specifications An out-of-specification result was observed in the r... | Class II | Ascend Laboratories, LLC |
| May 23, 2025 | Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx... | Failed Impurities/Degradation Specifications An out-of-specification result was observed in the r... | Class II | Ascend Laboratories, LLC |
| May 19, 2025 | Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manuf... | Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances t... | Class III | Glenmark Pharmaceuticals Inc., USA |
| May 13, 2025 | Esomeprazole Magnesium for Delayed-Release Oral Suspension, 40 mg, 30-count S... | Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any ... | Class II | Zydus Pharmaceuticals (USA) Inc |
| May 13, 2025 | Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg, 30-count s... | Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any ... | Class II | Zydus Pharmaceuticals (USA) 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.