Browse Drug Recalls

14,380 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14,380 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 14,380 FDA drug recalls, Class II.

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DateProductReasonClassFirm
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 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 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 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 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
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 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 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.
Apr 23, 2026 Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (1... Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by th... Class II Thea Pharma, Inc.
Apr 22, 2026 BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl ... Lack of assurance of Sterility: potential product contamination Class II CareFusion 213, LLC
Apr 22, 2026 BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl ... Lack of assurance of Sterility: potential product contamination Class II CareFusion 213, LLC
Apr 21, 2026 Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr... CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit Class II Breckenridge Pharmaceutical, Inc.
Apr 21, 2026 Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in F... Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact pr... Class II Alcon Research LLC
Apr 21, 2026 GenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz), Distributed by: ... Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact pr... Class II Alcon Research LLC
Apr 20, 2026 NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles,... Chemical contamination; presence of lead and lithium above specification Class II Acella Pharmaceuticals, LLC
Apr 20, 2026 Optase Dry Eye Intense Drops (Glycerin 0.2%), packaged in 0.33 fl oz, Sterile... Lack of Assurance of Sterility Class II SCOPE HEALTH
Apr 17, 2026 FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nas... Lack of Assurance of Sterility Class II Harrow Eye LLC
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 TRIFLUENT PHARMA TRIDERGEL Wound Care Gel, (Benzalkonium Chloride 0.1%), 1.0 ... CGMP Deviations: product manufactured in the same facility under the same conditions as the produ... 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 Revitaderm Wound Care, First Aid Antiseptic Gel, Benzalkonium Chloride 0.1%) ... CGMP Deviations; product manufactured in the same facility under the same conditions as the produ... 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 8, 2026 Desmopressin Nasal Spray, USP, 10 mcg/0.1 mL, 5 mL bottle (50 doses), Rx only... Defective container: defect in a batch of bottle caps, specifically involving dislodged or missin... Class II Apotex Corp.
Apr 7, 2026 Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Sing... This recall is being conducted due to out of specification assay results in a limited number of b... Class II Hikma 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.