Browse Drug Recalls

6,250 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,250 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 6,250 FDA drug recalls.

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Date	Product	Reason	Class	Firm
Apr 18, 2017	TRI MIX 45.45/27.27/0.45 5ML MDV MCG/MG/MG/ML INJ, Injection, 45.45mcg/27.27m...	Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due ...	Class II	Key Pharmacy and Compounding Center
Apr 18, 2017	TRI MIX 40/30/2 5ML MDV MCG/MG/MG/ML INJ, Injection, 40mcg/30mg/2mg/mL, Rx on...	Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due ...	Class II	Key Pharmacy and Compounding Center
Apr 18, 2017	FOLINIC ACID MDV INJ, Injection, 10 mg/mL, Rx only, packaged in 2mL and 10 mL...	Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due ...	Class II	Key Pharmacy and Compounding Center
Apr 18, 2017	HYDROXO-B12 PBF MDV 10MG/ML INJ, Injection, 10mg/mL, Rx only, packaged in a 5...	Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due ...	Class II	Key Pharmacy and Compounding Center
Apr 18, 2017	SODIUM BICARB 50ML MDV 8.4% (2 MOSMOL/ML) INJ, Injection, 8.40%, Rx only, 5...	Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due ...	Class II	Key Pharmacy and Compounding Center
Apr 18, 2017	PGE1/CPZ 5ML MDV 20MCG/1MG/ML INJ, Injection, 20mcg/1mg/mL, Rx only, 5 mL Gla...	Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due ...	Class II	Key Pharmacy and Compounding Center
Apr 18, 2017	METHYL-B12 5ML MDV (CALIF) 1MG/ML INJ, Injection, 1mg/mL, Rx only, 5 mL Glass...	Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due ...	Class II	Key Pharmacy and Compounding Center
Apr 18, 2017	TRI MIX 13/30/0.8 5ML MDV MCG/MG/MG/ML INJ, Injection, 13mcg/30mg/0.8mg/mL, R...	Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due ...	Class II	Key Pharmacy and Compounding Center
Apr 18, 2017	TRI MIX 10/30/0.5 5ML MDV MCG/MG/MG/ML INJ, Injection,10mcg/30mg/0.5mg/mL, ...	Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due ...	Class II	Key Pharmacy and Compounding Center
Apr 18, 2017	CO-Q-10 OIL 20ML MDV (CALIF) 25MG/ML INJ, Injection, 25mg/mL, Rx only, 20mL...	Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due ...	Class II	Key Pharmacy and Compounding Center
Apr 18, 2017	TRI MIX 6/18/0.6 5ML MDV MCG/MG/MG/ML INJ, Injection, 6mcg/18mg/0.6mg/mL, Rx ...	Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due ...	Class II	Key Pharmacy and Compounding Center
Apr 18, 2017	PGE1 5ML MDV INJ, Injection, 40mcg/mL, Rx only, 5mL glass/Multiple Dose vial...	Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due ...	Class II	Key Pharmacy and Compounding Center
Apr 18, 2017	VIT C/GSH 1.25%-1.25% OPHTH, Ophthalmic, 1.25%, Rx only, 15 mL Plastic/ Multi...	Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due ...	Class II	Key Pharmacy and Compounding Center
Apr 18, 2017	SODIUM CHLORIDE INH PF GV 0.9% SOLN, Inhalation Solution, 0.90%, Rx only, 5mL...	Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due ...	Class II	Key Pharmacy and Compounding Center
Apr 6, 2017	Cyanocobalamin 1 mg/mL/ Methionine 25 mg/mL/ Inositol 50 mg/mL/ Choline 50 mg...	Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste...	Class II	Isomeric Pharmacy Solution, LLC
Apr 6, 2017	Triamcinolone Diacetate 40 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Onl...	Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste...	Class II	Isomeric Pharmacy Solution, LLC
Apr 6, 2017	Testosterone Cypionate 200 mg/mL, Testosterone Propionate 20 mg/mL, 30 mL Mul...	Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste...	Class II	Isomeric Pharmacy Solution, LLC
Apr 6, 2017	Triamcinolone Acetonide 40 mg/mL, Lidocaine HCl 10 mg/mL , 10 mL Multi-Dose V...	Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste...	Class II	Isomeric Pharmacy Solution, LLC
Apr 6, 2017	Methylprednisolone Acetate 40 mg/mL, Lidocaine HCl 10 mg/mL, 10 mL Multi-Dose...	Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste...	Class II	Isomeric Pharmacy Solution, LLC
Apr 6, 2017	Phenylephrine 2.5%, Tropicamide 1%, 15 mL Multi-Dose Ophthalmic (spelled Opth...	Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste...	Class II	Isomeric Pharmacy Solution, LLC
Apr 6, 2017	Methylprednisolone Acetate 80 mg/mL, Lidocaine HCl 10 mg/mL, 10 mL Multi-Dose...	Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste...	Class II	Isomeric Pharmacy Solution, LLC
Mar 17, 2017	LATANOPROST OPHTHALMIC SOLUTION, 0.005%, 125 ug/2.5 mL, packaged in 2.5 mL b...	Lack of assurance of sterility: product was found to be empty, under-filled, or leaking.	Class II	Akorn, Inc.
Mar 10, 2017	Fluconazole Injection, USP, 400 mg in 200 mL, Rx only, Manufactured for: Clar...	Lack of Assurance of Sterility: there is potential of a leak from the primary container which may...	Class II	Claris Lifesciences Inc
Mar 10, 2017	Levofloxacin Injection in 5% Dextrose, 750 mg in 150 mL 5% Dextrose, Rx only...	Lack of Assurance of Sterility: there is potential of a leak from the primary container which may...	Class II	Claris Lifesciences Inc
Mar 10, 2017	Ciprofloxacin in Dextrose (5%) Injection, USP, 400 mg in 200 mL 5% Dextrose, ...	Lack of Assurance of Sterility: there is potential of a leak from the primary container which may...	Class II	Claris Lifesciences Inc
Mar 10, 2017	Metronidazole Injection, USP, 500 mg/100 mL, Rx only, Manufactured for: Clari...	Lack of Assurance of Sterility: there is potential of a leak from the primary container which may...	Class II	Claris Lifesciences Inc
Feb 22, 2017	Edex (alprostadil for injection) 10mcg, packaged in a 2 pack carton, Rx only,...	Lack of Assurance of Sterility: Defective container resulting in the lack of sterility assurance....	Class II	Endo Pharmaceuticals, Inc.
Feb 16, 2017	Optic Splash (naphazoline hydrochloride) Eye Drops, packaged in 0.5 FL OZ (15...	Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring enviro...	Class II	Sato Pharmaceutical Inc.
Feb 16, 2017	DORAMA-NEO (naphazoline hydrochloride) Eye wash, packaged in 0.5 FL OZ (15mL)...	Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring enviro...	Class II	Sato Pharmaceutical Inc.
Feb 16, 2017	SATO CLEAR (naphazoline hydrochloride) Redness Reliever Eye Drops, packaged i...	Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring enviro...	Class II	Sato Pharmaceutical Inc.
Feb 10, 2017	REVERSE DML LOTION (Ketoconazole 2%, Metronidazole 2%, sulfacetamide sodium 1...	Lack of Assurance of Sterility: There are also CGMP Deviations.	Class II	Synergy Rx
Feb 10, 2017	LP CREAM (Lidocaine 15%/Prilocaine 5%), Rx only, Synergy RX, 4901 Morena Blvd...	Lack of Assurance of Sterility: There are also CGMP Deviations.	Class II	Synergy Rx
Feb 10, 2017	CUSTOM LIGHTENING/BRIGHTENING CREAM, Rx only, Synergy RX, 4901 Morena Blvd # ...	Lack of Assurance of Sterility: There are also CGMP Deviations.	Class II	Synergy Rx
Feb 10, 2017	TRI-BLEACHING CREAM (Retinoic Acid 0.1%, Hydroquinone 4%, Fluocinolone 0.01%)...	Lack of Assurance of Sterility: There are also CGMP Deviations.	Class II	Synergy Rx
Feb 10, 2017	HYDROCORTISONE 2.5% WITH ALOE VERA CREAM, Rx only, Synergy RX, 4901 Morena Bl...	Lack of Assurance of Sterility: There are also CGMP Deviations.	Class II	Synergy Rx
Feb 10, 2017	CLOBETASOL 0.05% IN OLEA BASE, CLOBETASOL 0.05% IN OROBASE, CLOBETASOL 0.05% ...	Lack of Assurance of Sterility: There are also CGMP Deviations.	Class II	Synergy Rx
Feb 10, 2017	INTIMATE BLEACHING CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San D...	Lack of Assurance of Sterility: There are also CGMP Deviations.	Class II	Synergy Rx
Feb 10, 2017	HYDROQUINONE 28% SOLUTION, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San ...	Lack of Assurance of Sterility: There are also CGMP Deviations.	Class II	Synergy Rx
Feb 10, 2017	KOJIC ACID 8%/AZELAIC ACID 15% CREAM, Rx only, Synergy RX, 4901 Morena Blvd #...	Lack of Assurance of Sterility: There are also CGMP Deviations.	Class II	Synergy Rx
Feb 10, 2017	ULTRA LITE CREAM (Hydroquinone 8%), Rx only, Synergy RX, 4901 Morena Blvd # 5...	Lack of Assurance of Sterility: There are also CGMP Deviations.	Class II	Synergy Rx
Feb 10, 2017	CLARIFYING CREAM (Retinoic acid 0.025%, Salicylic Acid 1%, Green tea powder, ...	Lack of Assurance of Sterility: There are also CGMP Deviations.	Class II	Synergy Rx
Feb 10, 2017	HYDROQUINONE CREAM in all strengths including 4%, 5%,6%, 7%, 8%, HYDROQUINON...	Lack of Assurance of Sterility: There are also CGMP Deviations.	Class II	Synergy Rx
Feb 10, 2017	GENTLE SUPREME BLEACHING CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A...	Lack of Assurance of Sterility: There are also CGMP Deviations.	Class II	Synergy Rx
Feb 10, 2017	HCG in all strength including: 2,400, 9600,12,000 UNIT POWDER VIAL DROPS, HCG...	Lack of Assurance of Sterility: There are also CGMP Deviations.	Class II	Synergy Rx
Feb 10, 2017	ROSACEA CREAM ( Metronidazole 1%, Niacinamide 4%), Rx only, Synergy RX, 4901 ...	Lack of Assurance of Sterility: There are also CGMP Deviations.	Class II	Synergy Rx
Feb 10, 2017	ENHANCED RETIN ANTI-WRINKLE CREAM, ENHANCED RETIN ANTI-WRINKLE CREAM 0.1%, EN...	Lack of Assurance of Sterility: There are also CGMP Deviations.	Class II	Synergy Rx
Feb 10, 2017	UREA 40% Cream, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 9...	Lack of Assurance of Sterility: There are also CGMP Deviations.	Class II	Synergy Rx
Feb 10, 2017	AZELAIC ACID 15% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Die...	Lack of Assurance of Sterility: There are also CGMP Deviations.	Class II	Synergy Rx
Feb 10, 2017	SULFUR 5% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA ...	Lack of Assurance of Sterility: There are also CGMP Deviations.	Class II	Synergy Rx
Feb 10, 2017	SULFACETAMIDE 10%/HYDROCORTISONE 1% CREAM, Rx only, Synergy RX, 4901 Morena B...	Lack of Assurance of Sterility: There are also CGMP Deviations.	Class II	Synergy Rx

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.