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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.