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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
Jun 26, 2017 Potassium PHOSphate in 5% Dextrose Injection, 30 mMol 500 mL in 500 mL Intrav... Lack of Assurance of Sterility; media fill failure at manufacturer Class II PharMedium Services, Llc
Jun 26, 2017 Potassium PHOSphate in 0.9% Sodium Chloride Injection, 40 mMol in 250 mL in 2... Lack of Assurance of Sterility; media fill failure at manufacturer Class II PharMedium Services, Llc
Jun 26, 2017 Potassium PHOSphate in 0.9% Sodium Chloride Injection 20 mMol in 100 mL in 15... Lack of Assurance of Sterility; media fill failure at manufacturer Class II PharMedium Services, Llc
Jun 26, 2017 Potassium PHOSphate in 0.9% Sodium Chloride Injection, 10 mMol in a) 100 mL i... Lack of Assurance of Sterility; media fill failure at manufacturer Class II PharMedium Services, Llc
Jun 26, 2017 Potassium PHOSphate in 0.9% Sodium Chloride Injection, 9 mMol in 100 mL in 15... Lack of Assurance of Sterility; media fill failure at manufacturer Class II PharMedium Services, Llc
Jun 26, 2017 Potassium PHOSphate in 5% Dextrose Injection, 9 mMol in 50 mL in 50 mL Intrav... Lack of Assurance of Sterility; media fill failure at manufacturer Class II PharMedium Services, Llc
Jun 22, 2017 Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 15 mmol in NS ... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Jun 22, 2017 Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 30 mmol in NS ... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Jun 22, 2017 QUELICIN (Succinylcholine Chloride) Injection, USP 20 mg/mL in a) 5 mL vial (... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Jun 22, 2017 Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 20 mmol in NS ... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Jun 21, 2017 Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 15 mMol (22 mEq K+) ... Lack of sterility assurance Class II SCA Pharmaceuticals
Jun 21, 2017 Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 10 mMol (14.67 mEq K... Lack of sterility assurance Class II SCA Pharmaceuticals
Jun 21, 2017 Potassium PHOSphate added to 0.9% Sodium Chloride 250 mL Bag 30 mMol (44 mEq ... Lack of sterility assurance Class II SCA Pharmaceuticals
Jun 21, 2017 Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 15 mMol (22 mEq K+) ... Lack of sterility assurance Class II SCA Pharmaceuticals
Jun 19, 2017 Succinylcholine Chloride, 100 mg per 5mL, 20 mg per mL syringe. IV Use Only.... Lack Of Assurance Of Sterility: voluntary recall initiated by the commercial supplier Class II Fagron Compounding Services LLC dba Fagron Ster...
Jun 16, 2017 Clindamycin Injection USP; 600 mg/4 mL (150 mg/mL). 4 mL Single-dose ADD-VANT... Lack of Assurance of Sterility Class II Alvogen, Inc
Jun 16, 2017 Clindamycin Injection USP; 300 mg/2 mL (150 mg/mL). 2 mL Single-dose ADD-VANT... Lack of Assurance of Sterility Class II Alvogen, Inc
Jun 16, 2017 Clindamycin Injection USP; 900 mg/6 mL (150 mg/mL). 6 mL Single-dose ADD-VANT... Lack of Assurance of Sterility Class II Alvogen, Inc
Jun 15, 2017 Neut Sodium Bicarbonate 4% (2.4 mEq) Additive Solution 5 mL , a.) Single-dose... Lack of Sterility Assurance Class II Hospira a Pfizer Company
Jun 15, 2017 8.4% Sodium Bicarbonate Inj., USP 50 mL Single-dose, 50 mEq (1 mEq/mL) 4.2 gr... Lack of Sterility Assurance Class II Hospira a Pfizer Company
Jun 15, 2017 Succinylcholine Chloride Injection, USP 200 mg (20 mg/mL) Quelicin Multiple-d... Lack of Sterility Assurance Class II Hospira a Pfizer Company
Jun 15, 2017 Potassium Phosphates Inj., USP, 45 mM (3 mM P/mL) Also contains: 66 mEq K+ (4... Lack of Sterility Assurance Class II Hospira a Pfizer Company
Jun 1, 2017 methylcobalamin 1mg/1mL, vial for injection, Rx only, MedPark Pharmacy 2002 ... Lack of Assurance of Sterility Class II MedPark Pharmacy, LLC
May 18, 2017 ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable, 2g, Total ... Lack of assurance of sterility: Product bags leaking at seam. Class II SCA Pharmaceuticals
May 18, 2017 fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total... Lack of assurance of sterility: Product bags leaking at seam. Class II SCA Pharmaceuticals
May 18, 2017 morphine sulfate in 0.9% Sodium Chloride injectable, 1 mg per mL, Total Volum... Lack of assurance of sterility: Product bags leaking at seam. Class II SCA Pharmaceuticals
May 18, 2017 fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total... Lack of assurance of sterility: Product bags leaking at seam. Class II SCA Pharmaceuticals
May 18, 2017 morphine sulfate in 0.9% Sodium Chloride injectable, 1 mg per mL, Total Volum... Lack of assurance of sterility: Product bags leaking at seam. Class II SCA Pharmaceuticals
May 18, 2017 PHENYLephrine HCL in 0.9% Sodium Chloride injectable, 10 mg (Final Concentrat... Lack of assurance of sterility: Product bags leaking at seam. Class II SCA Pharmaceuticals
May 18, 2017 HYDROmorphone HCL in 0.9% Sodium Chloride injectable, 0.2 mg per ml, Total Vo... Lack of assurance of sterility: Product bags leaking at seam. Class II SCA Pharmaceuticals
May 18, 2017 fentaNYL (as citrate) in 100mL 0.9% Sodium Chloride injectable,20 mcg per mL,... Lack of assurance of sterility: Product bags leaking at seam. Class II SCA Pharmaceuticals
May 18, 2017 ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable, 3g, Total ... Lack of assurance of sterility: Product bags leaking at seam. Class II SCA Pharmaceuticals
May 18, 2017 MAGNESIUM Sulfate added to 100 mL 0.9% Sodium Chloride injectable, 4g, Total ... Lack of assurance of sterility: Product bags leaking at seam. Class II SCA Pharmaceuticals
May 15, 2017 Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intrav... Lack of assurance of sterility: customer complaints received for the presence of leaks. Class II Baxter Healthcare Corporation
May 15, 2017 Milrinone Lactate in 5% Dextrose Injection, 20 mg/100 mL, 100 mL Single-Dose ... Lack of assurance of sterility: customer complaints received for the presence of leaks. Class II Baxter Healthcare Corporation
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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

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.