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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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DateProductReasonClassFirm
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 CYANOCOBALAMIN 10ML MDV 1MG/ML INJ, Injection, 1mg/mL, Rx only, 10mL Glass/Mu... 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 ATROPINE SULFATE 0.01% OPHTH, Ophthalmic, 0.01%, Rx only, 15 mL Glass /Multip... 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 5ML MDV 50MG/ML INJ, 50mg/mL, Rx only, 5mL Glass/Multiple Do... 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 B COMPLEX 1ML SDV NA INJ, Injection, 100mg/2mg/2mg/2mg/100mg/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 TRI MIX 20/30/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 20mcg/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 5/30/0.5 5ML MDV MCG/MG/MG/ML INJ, Injection, 5mcg/30mg/0.5mg/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 PROGESTERONE SESAME OIL 10ML MDV 100MG/ML INJ, Injection, 100mg/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 FERR GLUC MDV 60MG/ML INJ, Injection, 60mg/mL, Rx only, Packaged in 5mL and 1... 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 DMSO 6.25% OPHTH., 6.25%, Rx only, 15 mL plastic/Multiple Dose bottle, Prepar... 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 ATROPINE SULFATE 0.5% OPHTH, Ophthalmic 0.50%, Rx only, 15mlLGlass /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 MAGNESIUM SO4 10ML MDV 50% INJ, Injection, 50%, 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 10/15/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 10mcg/15mg/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 HYDROXO-B12 30ML PBF MDV (CALIF) 1MG/ML INJ, Injection, 1mg/mL, Rx only, 30 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 10ML PBF MDV 5MG/ML INJ, 5mg/mL, Rx only, 10 mL Glass/ Multiple D... 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 GSH/NAC INH 2ML PV 60/100MG/ML SOLN, Inhalation Solution, 60mg/100mg/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 GSH/NAC INH PV 150/50MG/ML SOLN, Inhalation Solution, 150mg/50mg/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 TRI MIX 20/30/2 5ML MDV MCG/MG/MG/1ML INJ, Injection, 20mcg/30mg/2mg/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 PGE1 MDV 20MCG/ML INJ, Injection, 20mcg/mL, Rx only, packaged in a 5 mL, 10mL... 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 40/30/4 5ML MDV MCG/MG/MG/ML INJ, Injection, 40mcg/30mg/4mg/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 IRON SPECIAL 5ML MDV 60/10MG/5MCG/ML INJ, Injection, 60mg/1mg/5mcg/mL, Rx onl... 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 FOLIC ACID 1ML SDV 10MG/ML INJ, Injection, 10mg/mL, Rx only, 1 mL glass/Singl... 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 FERR GLUC/PROCAINE 10ML MDV 60/10MG/ML INJ, Injection, 60mg/10mg/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 CHOL/IN/ME(L)/B6 10ML MDV 50/50/25/0.1MG/ML INJ, Injection, 50mg/50mg/25mg/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 PAPAVERINE/PHENT 5ML MDV 30/0.5MG/ML INJ, Injection, 30/0.5mg/mL, Rx only, 5m... 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 GLUTATHIONE INH *PV* 200MG/ML SOLN, Inhalation Solution, 200mg/mL, Rx only, 4... 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 20/30/0.5 5ML MDV MCG/MG/MG/ML INJ, Injection, 20mcg/30mg/0.5mg/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 PROCAINE HCL SDV 2% INJ, Injection, 2%, Rx only, packaged in 10mL and 50 mL G... 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 DMPS ACID *5ML* SDV 50MG/ML INJ, Injection, 50mg/ml, Rx only, 5 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 FOLINIC ACID MDV (CALIF) 5MG/ML INJ, Injection, 5mg/mL, Rx only, packaged in ... Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due ... Class II Key Pharmacy and Compounding Center

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.