Browse Drug Recalls

522 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 522 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 522 FDA drug recalls in 2026.

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DateProductReasonClassFirm
May 22, 2026 Xyvona (levorphanol tartrate tablets), 3mg, 100 Tablets, Rx only, Forte BioPh... Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by F... Class II SUN PHARMACEUTICAL INDUSTRIES INC
May 22, 2026 Xyvona (levorphanol tartrate tablets), 2mg, 100 Tablets, Rx only, Forte BioPh... Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by F... Class II SUN PHARMACEUTICAL INDUSTRIES INC
May 22, 2026 Zep, Alcohol Sanitizer Spray, Ethanol 70%, Net Contents 55 Gallons 208 Liters... Microbial contamination of sterile products Class II Zep Inc
May 21, 2026 Pearson Quality Topical Anesthetic Gel (20% Benzocaine), Mint Flavor, Net Con... Defective container:may contain bottles with incomplete seals Class II Keystone Industries
May 21, 2026 safco SensiCaine-Ultra (20% Benzocaine), Topical Anesthetic Gel, Strawberry F... Defective container:may contain bottles with incomplete seals Class II Keystone Industries
May 21, 2026 Dental City TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, Strawberry Flavor, 1 OZ ... Defective container:may contain bottles with incomplete seals Class II Keystone Industries
May 21, 2026 Burkhart topical anesthetic gel, benzocaine 20 %, Strawberry Flavor, 1 oz (30... Defective container:may contain bottles with incomplete seals Class II Keystone Industries
May 21, 2026 Quala Dental Products, Topical Anesthetic Gel, 20 % Benzocaine, Strawberry Fl... Defective container:may contain bottles with incomplete seals Class II Keystone Industries
May 21, 2026 PureLife, TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, 1 oz (30mL), Strawberry Fl... Defective container:may contain bottles with incomplete seals Class II Keystone Industries
May 21, 2026 DHP Topical Anesthetic Gel, Benzocaine 20%, Strawberry Flavor, 1 oz. (30 g), ... Defective container:may contain bottles with incomplete seals Class II Keystone Industries
May 19, 2026 Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS : 50-41-9), Net ... cGMP deviations Class II Shimoga Chemicals
May 18, 2026 PReye Vitamin See Antioxidant Preservative Free Eye Drops, Distributed by: PR... Lack of Assurance of Sterility Class II PReye LLC
May 18, 2026 Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride, syringe, IntegraDose Compou... Subpotent Drug Class II IntegraDose Compounding Services LLC
May 18, 2026 Lidocaine HCl Injection, USP 2%, 40 mg/2 mL (20 mg/mL), 2 mL per Single-Dose ... Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan Class III Eugia US LLC
May 18, 2026 PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Ste... Failed Stability Specifications Class III AbbVie Inc.
May 15, 2026 VistaPharm, KERR INSTA-CHAR IN AN SORBITOL BASE WITH CHERRY FLAVOR, 50 Grams ... Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023 Class II PAI Holdings LLC
May 15, 2026 VistaPharm, KERR INSTA-CHAR IN AN AQUEOUS BASE WITH CHERRY FLAVOR, 25 Grams A... Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023 Class II PAI Holdings LLC
May 15, 2026 VistaPharm, KERR INSTA-CHAR IN AN SORBITOL BASE WITH CHERRY FLAVOR, 25 Grams ... Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023 Class II PAI Holdings LLC
May 15, 2026 VistaPharm, KERR INSTA-CHAR IN AN AQUEOUS BASE WITH CHERRY FLAVOR, 50 Grams A... Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023 Class II PAI Holdings LLC
May 14, 2026 Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius... Failed Impurities/Degradations Specifications Class III Fresenius Kabi USA, LLC
May 14, 2026 Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem ... CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-dulox... Class II Asclemed USA 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.
May 12, 2026 DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL singl... Presence of Particulate matter: Particulate matter identified as glass. Class I SUN PHARMACEUTICAL INDUSTRIES INC
May 12, 2026 Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distribut... Lack of Assurance of Sterility Class II Spectra Medical Devices, Llc
May 12, 2026 Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx on... Defective Container; packets were found to be either empty or partially full. Class II ANI Pharmaceuticals, Inc.
May 12, 2026 fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Wate... Subpotent Drug Class II IntegraDose Compounding Services LLC
May 11, 2026 Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, War... Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labe... Class II Haleon US Holdings LLC
May 8, 2026 cimzia (certolizumab pegol), 2x200mg/mL PREFILLED SYRINGES (2 single-dose), R... Lack of Assurance of Sterility Class II UCB Biosciences Inc.
May 5, 2026 Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bott... Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications Class II Ascend Laboratories, LLC
May 4, 2026 Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials,... Failed Impurities/Degradation Specifications Class III Sagent Pharmaceuticals
May 1, 2026 Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid, Con... Presence of a Foreign Substance; black particles observed in liquid Class II Safecor Health, LLC
May 1, 2026 Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per c... Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. Class III Amerisource Health Services LLC
May 1, 2026 Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per ca... Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. Class III Amerisource Health Services LLC
Apr 30, 2026 Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are ... Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg ... Class II Safecor Health, LLC
Apr 29, 2026 Erythromycin Tablets, USP, 250 mg, 30 tablets per bottle, Rx only, Manufactur... CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable in... Class II Zydus Pharmaceuticals (USA) Inc
Apr 29, 2026 Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only, Manufactur... CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable in... Class II Zydus Pharmaceuticals (USA) 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 28, 2026 Lactated Ringer's Injection USP, 1000 mL container, Rx only, B. Braun Medical... Presence of Particulate Matter. Class I B BRAUN MEDICAL INC
Apr 27, 2026 Primidone Tablets, USP, 250 mg, 100-count bottle, RX only, Manufactured by: L... Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. Class III Golden State Medical Supply Inc.
Apr 27, 2026 Primidone Tablets, USP, 50 mg, 50-count bottle, RX only, Manufactured by: Lan... Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. Class III Golden State Medical Supply Inc.
Apr 27, 2026 Ascend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablets, USP,... Failed Dissolution Specifications Class II Ascend Laboratories, LLC
Apr 27, 2026 Oasis Tears PF, Preservative-Free Lubricant Eye Drops, 10mL/0.34 Fl OZ Bottle... Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution foll... Class II Oasis Medical, Inc.
Apr 24, 2026 Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lann... Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. Class III Lannett Company Inc.
Apr 24, 2026 MG217 Multi-Symptom Treatment Cream & Skin Protectant (colloidal oatmeal 2%),... Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus. Class I Wisconsin Pharmacal Company
Apr 24, 2026 Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin... Presence of particulate matter: a white thread-like structure in the cartridge Class II Lupin Pharmaceuticals Inc.
Apr 24, 2026 Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, ... Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food ... Class II Teva Pharmaceuticals USA, Inc
Apr 23, 2026 Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only, Manufactu... Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impu... Class II JB Chemicals and Pharmaceuticals Ltd
Apr 23, 2026 iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made... Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by th... Class II Thea 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.