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Browse Drug Recalls

1,141 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,141 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 1,141 FDA drug recalls in 2017.

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DateProductReasonClassFirm
Apr 18, 2017 HYDROXO-B12 5ML PBF MDV 1MG/ML INJ, Injection, 1mg/ml, Rx only, packaged in 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 HYDROXO-B12 *1ML* SDV 1MG/ML INJ, Injection, 1mg/mL, Rx only, 1 mL Glass/Sing... 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 11.8/17.6/0.59 5ML MDV MCG/MG/MG/ML INJ, Injection, 11.8mcg/17.6mg/0.... 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 10/15/2.5 5ML MDV MCG/MG/MG/ML INJ, Injection, 10mcg/15mg/2.5mg/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 10/30/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 10mcg/30mg/1mg/mL, Rx o... 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 PROCAINE HCL 50ML MDV (CALIF) 1% INJ, Injection, 1%, Rx only, 50mL Glass/Mul... 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 5-MTHF 10ML SDV (CALIF) 5MG/ML INJ, Injection 5mg/mL, Rx only, 10mL Glass /Si... 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 INH PF GV 5MG/ML SOLN, Inhalation Solution, 5mg/mL, Rx only, 5 m... 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 20/20/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 20mcg/20mg/1mg/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 QUAD MIX 1/30/0.5/0.1 5ML MDV MCG/MG/MG/MG/ML INJ, Injection, 1mcg/30mg/0.5mg... 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/PAP 10/30 5ML MDV MCG/MG/ML INJ, Injection, 10mg/30mg/mL, 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 18, 2017 Riomet (metformin hydrochloride) Oral Solution Cherry Flavored 500 mg /5 mL, ... Microbial Contamination of Non-Sterile Products Class II Sun Pharmaceutical Industries, Inc.
Apr 18, 2017 TESTOST AQ MDV 50MG/ML INJ, Injection, 50mg/mL, Rx only, packaged in 5mL and... 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 PYRIDOXAL-5-PHOS 10ML MDV 100MG/ML INJ, Injection, 100mg/mL, Rx only, 10mL Gl... 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 *10ML* MDV 5MG/ML INJ, Injection, 5mg/mL, Rx only, 10 mL Glass/Mul... 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 SOD PHENYLBUTYRATE SDV 30ML (CALIF or NEZ-CALIF) 200MG/ML INJ, Injection, 200... 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/PROCAINE 5ML MDV 40MCG/ML/0.1% INJ, Injection, 40mcg/mL, 0.1%, Rx only, ... 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 HCG *10ML* MDV 500U/ML INJ, Injection, 500u/mL, Rx only, 10 mL Glass/Multiple... 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 30/30/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 30mcg/30mg/1mg/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 TRI MIX 5.88/17.65/0.588 5ML MDV MCG/MG/MG/ML INJ, , Injection, 5.88mcg/17.65... 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 5-MTHF SDV 5MG/ML INJ, Injection, 5mg/mL, Rx only, packaged in 1 mL, 2 mL, 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 TRI MIX 16.7/4/0.27 5ML MDV MCG/MG/MG/ML INJ, Injection, 16.7mcg/4mg/0.27mg/m... 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 1ML SDV 10MG/ML INJ, Injection, 10mg/mL, Rx only, 1 mL glass/ Si... 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 TESTOST CYP SESAME OIL 5ML MDV 100MG/ML INJ, Injection, 100mg/mL, 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 Cummor Natural Male Enhancement, Herbal Dietary Supplement Capsules, 500 mg, ... Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, s... Class I Organic Herbal Supply
Apr 18, 2017 5-MTHF *10ML* MDV 5MG/ML INJ, Injection, 5mg/mL, Rx only, 10mL Glass/Multiple... 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 PAPAVERINE/PHENT 5ML MDV 30/1MG/ML INJ, Injection, 30mg/1mg/mL, 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 18, 2017 5-MTHF 10ML MDV (CALIF) 5MG/ML INJ, Injection, 5mg/mL, Rx only, 10mLGlass/Mul... 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 5.95/17.8572/0.6 5ML MDV MCG/MG/MG/ML INJ, Injection, 5.95mcg/17.85mg... 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 5ML PBF MDV (CALIF) 10MG/ML INJ, Injection, 10mg/mL, 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 18, 2017 PROCAINE HCL SDV 1% INJ, Injection, 1%, Rx only, packaged in 5mL and 50 mL Gl... 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 VITAMIN D3 IN OLIVE OIL SDV 100,000U/ML INJ, Injection, 100,000u/mL, Rx only,... 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/PROCAINE 5ML MDV 20MCG/ML/0.1% INJ, Injection, 20mcg/ml 0.1%, 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 VITAMIN D3 IN OLIVE OIL SDV 100,000U/ML INJ, Injection, 150,000u/mL, Rx only,... 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 CARBOXYM-CELL PF 0.5% OPHTH, opthalmic, 0.50%, Rx only, 10mL Glass/Mul... 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 ALPHA LIPOIC ACID 25ML MDV 25MG/ML INJ, Injection, 25mg/mL, Rx only, 25 mL Gl... 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 ENHANCEROL Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4 and 1... Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, s... Class I Organic Herbal Supply
Apr 18, 2017 Xrect Male Enhancement Herbal Dietary Supplement Capsules, 500 mg supplied in... Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, s... Class I Organic Herbal Supply
Apr 18, 2017 ZDaily Daily Testosterone and Llibido Booster Herbal Dietary Supplement Capsu... Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, s... Class I Organic Herbal Supply
Apr 18, 2017 QUAD MIX 50/30/1/0.2 5ML MDV (CALIF) MCG/MG/MG/MG/ML INJ, Injection, 50mcg/30... 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 PROCAINE HCL *5ML* SDV SULFITE FREE 1% INJ, Injection, 1%, RXxonly, 5mL Glass... Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due ... Class II Key Pharmacy and Compounding Center
Apr 17, 2017 Allergy Relief Diphenhydramine HCl 25 mg, Antihistamine, Dye-Free, 24 Softgel... Subpotent: This product is being recalled due to low out of specification assay results at the 9... Class III P & L Development, LLC
Apr 17, 2017 EEMT (esterified estrogens and methyltestosterone) 1.25 mg/2.5 mg, tablets,10... CGMP deviations: Lots were recalled due to sub-potency and cGMP violations. Class II Syntho Pharmaceuticals, Inc.
Apr 17, 2017 EEMT HS (esterified estrogens and methyltestosterone) 0.625 mg/1.25 mg, table... CGMP deviations: Lots were recalled due to sub-potency and cGMP violations. Class II Syntho Pharmaceuticals, Inc.
Apr 17, 2017 ESTRONE USP, packaged in a) 1g bottle (NDC: 58597-8049-2), c) 5g bottle (NDC:... cGMP Deviations; lack of quality assurance. Class II American Pharmaceutical Ingredients LLC
Apr 17, 2017 Zinc Oxide Paste 25%, 500 g, For Prescription Compounding, Fagron Inc.2400 Pi... Labeling: Error on Declared Strength: Error is due to an incorrect value in the Drug Facts Panel.... Class III Fagron, Inc
Apr 13, 2017 Hyland's Baby Nighttime Teething Tablets [Belladonna 12X HPUS (0.000000000000... Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ... Class I Standard Homeopathic Company
Apr 13, 2017 Levonorgestrel, U.S.P. active pharmaceutical ingredient, packaged in 1 kg con... CGMP Deviations: these repackaged and redistributed products are being recalled due to a recall n... Class II Spectrum Laboratory Products, Inc.
Apr 13, 2017 Estradiol (17-B-Estradiol; Estra-1,3,5(10)-triene-3, 17B-diol; Oestradiol) Pl... CGMP Deviations: these repackaged and redistributed products are being recalled due to a recall n... Class II Spectrum Laboratory Products, Inc.
Apr 13, 2017 Hyland's Baby Teething Tablets [Calcarea Phosporica 6X HPUS, Chamomilla 6X HP... Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ... Class I Standard Homeopathic Company

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.