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
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
Mar 20, 2026 Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by... CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit. Class II Leading Pharma, LLC
Mar 20, 2026 QC Quality Choice, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, C... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey L... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Me... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 caring mill, Menthol Cough Suppressant Oral Anesthetic, Cough Drops, Cherry, ... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Va... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 exchange select, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Men... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 QC Quality Choice, Pectin Oral Demulcent, Throat Soothing Drops, Creamy Straw... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 QC Quality Choice, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, S... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Ho... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 Discount Drug Mart Food Market, Cough Drops, Menthol- Cough Suppressant Anest... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Su... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 exchange select, Menthol -Cough Suppressant Oral Anesthetic, Honey Lemon Flav... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 Discount Drug Mart Food Market, Cough Drops, Menthol -Cough Suppressant Anest... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Sugar F... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey L... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 Vancomycin HCL, 1 gram added to 250 mL, 0.9% Sodium Chloride Injection USP, F... Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port Class II Fagron Compounding Services
Mar 20, 2026 norepinephrine Bitartrate,16mg per 250mL 0.9% Sodium Chloride Injection USP, ... Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port Class II Fagron Compounding Services
Mar 20, 2026 norepinephrine Bitartrate, 32mg per 250mL 0.9% Sodium Chloride Injection USP,... Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port Class II Fagron Compounding Services

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.