Browse Drug Recalls

1,045 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,045 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 1,045 FDA drug recalls.

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DateProductReasonClassFirm
Jul 16, 2026 Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack further p... Failed impurity/degradation specification: an OOS result observed in Related substance test analy... Class III Ascend Laboratories, LLC
Jul 16, 2026 Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further pa... Failed impurity/degradation specification: an OOS result observed in Related substance test analy... Class III Ascend Laboratories, LLC
Jul 16, 2026 Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further pac... Failed impurity/degradation specification: an OOS result observed in Related substance test analy... Class III Ascend Laboratories, LLC
Jun 30, 2026 Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manuf... Failed Impurities/Degradation Specifications: OOS result was observed during the related substanc... Class III Ascend Laboratories, LLC
Jun 30, 2026 Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only, Manuf... Failed Impurities/Degradation Specifications: OOS result was observed during the related substanc... Class III Ascend Laboratories, LLC
Jun 23, 2026 Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g ... Subpotent Drug: Low out of specification assay results performed during long-term stability testing. Class II Padagis US LLC
Jun 23, 2026 Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg p... CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long... Class II Lupin Pharmaceuticals Inc.
May 29, 2026 GSMS Incorporated, NIACIN EXTENDED-RELEASE TABLETS, USP, 1,000 MG, 90 tablets... Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was o... Class II Golden State Medical Supply Inc.
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 8, 2026 TERPENICOL Antifungal Cream (Undecylenic Acid 13%), 1.0 oz (28 g) bottles, Ma... CGMP Deviations; the firm discontinued required stability testing for products on the market stil... Class II Blaine Labs Inc
Apr 8, 2026 vite20 Antifungal Cream, (10% Undecylenic Acid), 0.54 OZ (15 g) bottle, Manuf... CGMP Deviations; the firm discontinued required stability testing for products on the market stil... Class II Blaine Labs Inc
Apr 8, 2026 TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%), 1.25 FL OZ (37.5 mL)... CGMP Deviations; the firm discontinued required stability testing for products on the market stil... Class II Blaine Labs Inc
Apr 8, 2026 Fungal Fusion ERADICATION Solution, Antifungal & Antimicrobial Kit. Contains,... CGMP Deviations; the firm discontinued required stability testing for products on the market stil... Class II Blaine Labs Inc
Apr 8, 2026 TERPENICOL Antifungal Solution, (Undecylenic (10-Undecenoic) acid 25%), 1.0 F... CGMP Deviations; the firm discontinued required stability testing for products on the market stil... Class II Blaine Labs Inc
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.

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.