Browse Drug Recalls

17,582 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 17,582 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 17,582 FDA drug recalls.

Date	Product	Reason	Class	Firm
Sep 21, 2023	fentaNYL 1.5 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride / Total...	Lack of assurance of sterility:	Class II	Central Admixture Pharmacy Services Inc
Sep 21, 2023	ketamine in 0.9% sodium chloride, 50 mg/5mL (10mg/mL), 5 mL syringe, Rx only,...	Lack of assurance of sterility:	Class II	Central Admixture Pharmacy Services Inc
Sep 21, 2023	fentaNYL 2 mcg/mL and bupivacaine 0.0625% PF in 0.9% sodium chloride, Total V...	Lack of assurance of sterility:	Class II	Central Admixture Pharmacy Services Inc
Sep 21, 2023	succinylcholine, 200 mg/10 mL, (20 mg/mL), 10 mL syringe, Rx only, CAPS, Inc....	Lack of assurance of sterility:	Class II	Central Admixture Pharmacy Services Inc
Sep 21, 2023	HYDROmorphone in 0.9% sodium chloride, 15 mg/30 mL, (0.5 mg/mL), 30 mL Syring...	Lack of assurance of sterility:	Class II	Central Admixture Pharmacy Services Inc
Sep 21, 2023	Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 6...	Failed Dissolution Specifications	Class II	Zydus Pharmaceuticals (USA) Inc
Sep 21, 2023	midazolam in dextrose 5%, 50 mg/50 mL, (1 mg/mL), 50 mL Syringe, Rx only, Cen...	Lack of assurance of sterility:	Class II	Central Admixture Pharmacy Services Inc
Sep 21, 2023	fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL syringe, Rx ...	Lack of assurance of sterility:	Class II	Central Admixture Pharmacy Services Inc
Sep 21, 2023	fentaNYL in dextrose 5%, 300 mcg/30 mL, (10 mcg/mL), 30 mL syringe, Rx only, ...	Lack of assurance of sterility:	Class II	Central Admixture Pharmacy Services Inc
Sep 21, 2023	fentaNYL, 100 mcg/2 mL, (50 mcg/mL), 3 mL Syringe, Rx only, Repackaged by CAP...	Lack of assurance of sterility:	Class II	Central Admixture Pharmacy Services Inc
Sep 20, 2023	MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile O...	Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0%...	Class III	Imprimis NJOF, LLC
Sep 20, 2023	Betaxolol Tablets, USP 10 mg, Rx Only, 100 count bottles, Mfd by: KVK Tech In...	Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP...	Class I	KVK-Tech, Inc.
Sep 12, 2023	Eligard (leuprolide acetate) for injectable suspension, 7.5 mg every month, S...	Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.	Class III	Tolmar, Inc.
Sep 8, 2023	TheraBreath for Kids! Oral Rinse, sodium fluoride 0.05% (0.02% w/v fluoride i...	Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis	Class I	Church & Dwight Inc
Sep 8, 2023	SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL b...	Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.	Class I	Novartis Pharmaceuticals Corp.
Sep 7, 2023	Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouche...	Subpotent: Out of Specification result observed for low assay	Class III	SUN PHARMACEUTICAL INDUSTRIES INC
Sep 5, 2023	Kroger Mint Burst ANTISEPTIC MOUTH RINSE ANTIGINGIVITIS/ANTIPLAQUE (Eucalypto...	Incorrect/Undeclared Excipients.	Class III	Vi-Jon, LLC
Sep 5, 2023	Pantoprazole Sodium for Injection 40mg per vial, Single dose vials NDC 71839-...	Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.	Class II	BE PHARMACEUTICALS AG
Sep 1, 2023	TRP Natural Eyes, Stye Relief, Sterile Eye Ointment, Homeopathic 0.14 oz (4 g...	Lack of Assurance of Sterility	Class II	AMMAN PHARMACEUTICAL INDUSTRIES
Sep 1, 2023	TRP Natural Eyes, Pink Eye Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ ...	Lack of Assurance of Sterility	Class II	AMMAN PHARMACEUTICAL INDUSTRIES
Sep 1, 2023	TRP Natural Eyes, Blur Relief, Sterile Eye Drops, Homeopathic 0.5 FL OZ (15 m...	Lack of Assurance of Sterility	Class II	AMMAN PHARMACEUTICAL INDUSTRIES
Sep 1, 2023	TRP Natural Eyes, Pink Eye Relief PF, Sterile Eye drops, Homeopathic 0.33 FL ...	Lack of Assurance of Sterility	Class II	AMMAN PHARMACEUTICAL INDUSTRIES
Sep 1, 2023	TRP Natural Eyes, Dryness Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL O...	Lack of Assurance of Sterility	Class II	AMMAN PHARMACEUTICAL INDUSTRIES
Sep 1, 2023	TRP Natural Eyes, Twitching Relief, Sterile Eye Ointment, Homeopathic 0.33 FL...	Lack of Assurance of Sterility	Class II	AMMAN PHARMACEUTICAL INDUSTRIES
Sep 1, 2023	TRP Natural Eyes, Dryness Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (...	Lack of Assurance of Sterility	Class II	AMMAN PHARMACEUTICAL INDUSTRIES
Sep 1, 2023	TRP Natural Eyes, Eye Lid Relief, Sterile Eye ointment, Homeopathic 0.14 oz (...	Lack of Assurance of Sterility	Class II	AMMAN PHARMACEUTICAL INDUSTRIES
Sep 1, 2023	TRP Natural Eyes, Floaters Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ ...	Lack of Assurance of Sterility	Class II	AMMAN PHARMACEUTICAL INDUSTRIES
Sep 1, 2023	TRP Natural Eyes, Red Eye Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ (...	Lack of Assurance of Sterility	Class II	AMMAN PHARMACEUTICAL INDUSTRIES
Sep 1, 2023	MAJOR LubriFresh P.M. Nighttime Ointment, Lubricant Eye Ointment, Sterile, 0....	Lack of Assurance of Sterility	Class II	AMMAN PHARMACEUTICAL INDUSTRIES
Sep 1, 2023	TRP Natural Eyes, Aging Eye Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ...	Lack of Assurance of Sterility	Class II	AMMAN PHARMACEUTICAL INDUSTRIES
Sep 1, 2023	TRP Natural Eyes, Eye Lid Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL O...	Lack of Assurance of Sterility	Class II	AMMAN PHARMACEUTICAL INDUSTRIES
Sep 1, 2023	TRP Natural Eyes, Allergy Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL O...	Lack of Assurance of Sterility	Class II	AMMAN PHARMACEUTICAL INDUSTRIES
Sep 1, 2023	HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100 Tablets (10 x 10) per cart...	Failed Impurities/Degradation Specifications: Out of Specification results in the repackaged prod...	Class III	Amerisource Health Services LLC
Sep 1, 2023	octiq Lubricating Eye Drops, Dextran 70.01%, Hypromellose 0.3%, 0.5 FL OZ Eac...	Lack of Assurance of Sterility	Class II	AMMAN PHARMACEUTICAL INDUSTRIES
Sep 1, 2023	TRP Natural Eyes, Red Eye Relief PF, Sterile Eye drops, Homeopathic 0.33 FL O...	Lack of Assurance of Sterility	Class II	AMMAN PHARMACEUTICAL INDUSTRIES
Sep 1, 2023	TRP Natural Eyes, Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL...	Lack of Assurance of Sterility	Class II	AMMAN PHARMACEUTICAL INDUSTRIES
Aug 30, 2023	Sucralfate Oral Suspension 1g per 10mL, FOR ORAL ADMINISTRATION ONLY (414 mL ...	Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results	Class II	VistaPharm LLC
Aug 29, 2023	Clearasil Rapid Rescue Deep Treatment Pads (Salicylic Acid 2%), packaged in 9...	Labeling: Label Error on Declared Strength: The incorrect label on the back of the product packag...	Class III	RB Health (US) LLC
Aug 26, 2023	Dr. Berne's MSM DROPS 15% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr...	CGMP Deviations	Class II	Dr. Berne's Whole Health Products
Aug 26, 2023	Dr. Berne's MSM DROPS 5% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr....	CGMP Deviations	Class II	Dr. Berne's Whole Health Products
Aug 26, 2023	Dr. Berne's Organic Castor Oil Eye Drops, Net WT 30 mL/1 fl oz bottle, Distri...	CGMP Deviations	Class II	Dr. Berne's Whole Health Products
Aug 26, 2023	Dr. Berne's MSM MIST 15% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr....	CGMP Deviations	Class II	Dr. Berne's Whole Health Products
Aug 26, 2023	Dr. Berne's MSM DROPS 5% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr....	Non-Sterility	Class I	Dr. Berne's Whole Health Products
Aug 25, 2023	BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isoprop...	Stability data does not support expiry: Shelf-life of the impacted lots of BD ChloraPrep" Clear 1...	Class II	CareFusion 213, LLC
Aug 25, 2023	Digoxin Tablets, USP 0.125mg, 100-count bottles, Rx Only, Manufactured for/D...	Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets,...	Class I	Marlex Pharmaceuticals, Inc.
Aug 25, 2023	WEFUN Capsules 825 mg, 1x10 blister pack per carton, Manufactured by WEFUN Br...	Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenaf...	Class I	Hua Da Trading, Inc. dba Wefun Inc.
Aug 25, 2023	Digoxin Tablets, USP 0.25mg, 100-count bottles, Rx Only, Manufactured for/Di...	Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets,...	Class II	Marlex Pharmaceuticals, Inc.
Aug 24, 2023	Doxil (doxorubicin hydrochloride liposome injection) 50 mg in 25 mL (2 mg/mL)...	CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions dur...	Class II	Baxter Healthcare Corporation
Aug 23, 2023	Clindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Rx only, Manufa...	Defective Container: slow leakage under the cap	Class III	Contract Pharmaceuticals Limited Canada
Aug 22, 2023	Florbetaben F-18 (Neuraceq¿) Injection Solution 1.4 to 135 mCi/mL, 50 mL in 1...	Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity T...	Class II	Sofie Co dba Sofie

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.