Browse Drug Recalls
14,449 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 14,449 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 14,449 FDA drug recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Apr 6, 2026 | DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchan... | Lack of Assurance of Sterility: Potential leaks from perforations in bags. | Class II | Fresenius Medical Care Holdings, Inc. |
| Apr 6, 2026 | DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchan... | Lack of Assurance of Sterility: Potential leaks from perforations in bags. | Class II | Fresenius Medical Care Holdings, Inc. |
| Apr 6, 2026 | Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton,... | Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin | Class II | Teva Pharmaceuticals USA, Inc |
| Apr 2, 2026 | Lidocaine HCl Injection, USP, 2%, 100 mg/5mL (20 mg/mL), 5 mL Single-Dose Via... | Lack of Assurance of Sterility | Class II | Huons Co., Ltd. |
| Apr 2, 2026 | Lidocaine HCl injection, USP, 1% 50mg/5mL (10 mg/mL), 5 mL Single Dose Vials,... | Lack of Assurance of Sterility | Class II | Huons Co., Ltd. |
| Apr 2, 2026 | Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP (15 mg/2 mL)... | Lack of Assurance of Sterility | Class II | Huons Co., Ltd. |
| Apr 2, 2026 | 0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose, Pre... | Lack of Assurance of Sterility | Class II | Huons Co., Ltd. |
| Apr 2, 2026 | Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package... | Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is re... | Class II | B BRAUN MEDICAL INC |
| Apr 2, 2026 | 0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Bra... | Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is re... | Class II | B BRAUN MEDICAL INC |
| Apr 2, 2026 | LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medica... | Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is re... | Class II | B BRAUN MEDICAL INC |
| Apr 2, 2026 | DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B. Braun Medical... | Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is re... | Class II | B BRAUN MEDICAL INC |
| Apr 1, 2026 | fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 50 mcg/5mL)(10 ... | cGMP deviations. | Class II | Wells Pharma of Houston LLC |
| Apr 1, 2026 | Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag, wells phar... | cGMP deviations. | Class II | Wells Pharma of Houston LLC |
| Apr 1, 2026 | fentaNYL Citrate Injectable Solution, Narcotic, CII, 1250 mcg/25mL (50 mcg pe... | cGMP deviations. | Class II | Wells Pharma of Houston LLC |
| Apr 1, 2026 | fentaNYL Citrate Injectable Solution, NARCOTIC, Cii, 1000 mcg/100 mL (10 mcg ... | cGMP deviations. | Class II | Wells Pharma of Houston LLC |
| Apr 1, 2026 | fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500... | cGMP deviations. | Class II | Wells Pharma of Houston LLC |
| Apr 1, 2026 | fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL (... | cGMP deviations. | Class II | Wells Pharma of Houston LLC |
| Apr 1, 2026 | Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1... | cGMP deviations. | Class II | Wells Pharma of Houston 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... |
| Apr 1, 2026 | EPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL), Rx only, INTERNATIONAL MED... | Lack of Assurance of Sterility | Class II | International Medication Systems Ltd. |
| Mar 27, 2026 | Prazosin Hydrochloride Capsules, USP, 5mg, 100-count bottle, Rx Only, Manufac... | cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin im... | Class II | Appco Pharma LLC |
| Mar 27, 2026 | Prazosin Hydrochloride Capsules, USP, 2mg, 100-count bottle, Rx Only, Manufa... | cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin im... | Class II | Appco Pharma LLC |
| Mar 27, 2026 | Prazosin Hydrochloride Capsules, USP, 1mg, 100-count bottle, Rx Only, Manufac... | cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin im... | Class II | Appco Pharma LLC |
| Mar 26, 2026 | Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, ... | Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than no... | Class II | Hetero Labs Limited (Unit V) |
| 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 25, 2026 | Artificial Tears Lubricant Eye Drops (glycerin 0.2%, hypromellose 0.2%, polye... | Lack of Assurance of Sterility | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 24, 2026 | Memantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x ... | Failed Dissolution Specifications | Class II | The Harvard Drug Group LLC |
| Mar 24, 2026 | GE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL (64.7%), Rx Only, Dist... | Presence of particulate matter | Class II | GE Healthcare Ireland Limited |
| Mar 24, 2026 | GE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%), Rx Only, Dist... | Presence of particulate matter | Class II | GE Healthcare Ireland Limited |
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.