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Browse Drug Recalls

6,256 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,256 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 6,256 FDA drug recalls.

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DateProductReasonClassFirm
Oct 16, 2015 Methylcobalamin Injection Buffered 5mg/mL, 30mL vial, Rx only, Downing Labs, ... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Phosphatidylcholine/Deoxycholic Acid Injection (Preserved) 50 ML 10/4.75%; Ph... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 DMSO 99% Injection, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Sui... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Thiamine HCl Injection, 100mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 ... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 MICML TRNDPPC Injection (Preserved) 10mL vial, Rx only, Downing Labs, LLC 400... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Green Tea (EGCG) Injectable, 10mg/mL,10mL vial, Rx only, Downing Labs, LLC 40... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 DMAE Dimethylaminoethanol Injection, 100mg/mL, 30mL vial, Rx only, Downing La... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Co-Enzyme Q-10 Injectable, 20mg/mL, 10mL vial, Rx only, Downing Labs, LLC 400... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Potassium Chloride Injection (20mEq/10mL), 2mEq/ML, 10mL vial, Rx only, Downi... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 TNPDR Injection Buffered, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen R... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Magnesium Sulfate Injectable, 14.28%, 7mL vial, Rx only, Downing Labs, LLC 40... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Pyridoxine Injection, 100 mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 M... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 EDTA Disodium Injectable, 150mg/mL, 100mL vial, Rx only, Downing Labs, LLC 40... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Zinc Sulfate (Elemental) Injection, 10mg/mL, 30 mL vial, Rx only, Downing Lab... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Magnesium Sulfate Injection (4060mOsm/L), 50%, 50mL vial, Rx only, Downing La... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 EDTA Calcium Disodium Injectable, 300mg/mL, 50mL vial, Rx only, Downing Labs,... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Piracetam Injection, 200mg/mL,10mL vial, Rx only, Downing Labs, LLC 4001 McEw... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 L-Glutamine Injectable, 30mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 M... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Methylcobalamin Buffered Injectable, 1mg/mL, packaged in a) 10mL vial, b) 30m... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Magnesium Chloride Hexahydrate Injection 200mg/mL, 50mL vial, Rx only, Downin... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 L-Tyrosine Injectable, 25mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 Mc... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Hydroxocobalamin Injection (Buffered) 1mg/mL, 30mL vial, Rx only, Downing Lab... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Vitamin D3 Injectable, 10,000 U/mL, 10mL vial, Rx only, Downing Labs, LLC 400... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Ascorbic Acid Injectable 500mg/mL, packaged in a) 10mL vials, b) 50mL vials, ... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Calcium Gluconate (680mOsm/L) Injection 10%, 50mL vial, Rx only, Downing Labs... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 M.I.C Injection (Preserved), 25/50/25mg/mL, 50mL vial, Rx only, Downing Labs,... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Dexpanthenol Injection, 250mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 ... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Cyanocobalamin Buffered Injectable 3mg/mL, 30mL vial, Rx only, Downing Labs,... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Chromium Injectable, 200mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 Mc... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 9, 2015 Estradiol USP 99.5%, .5% Stearic Acid NF Pellets, 3 mL, one-count vials, 6 mg... Lack of Assurance of Sterility: The firm is recalling all sterile preparations within expiry due ... Class II Qualgen
Oct 9, 2015 Testosterone USP 99.5%, .5% Stearic Acid NF Pellets, 3 mL, one-count vials, 2... Lack of Assurance of Sterility: The firm is recalling all sterile preparations within expiry due ... Class II Qualgen
Oct 7, 2015 PAPA/PGE1/PHENTO (30mg/10mg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & ... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II Pacific Healthcare, Inc dba B&B Pharmacy
Oct 7, 2015 PGE 30mcg/ml Injection, 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflow... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II Pacific Healthcare, Inc dba B&B Pharmacy
Oct 7, 2015 PGE 25mcg/ml, Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflow... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II Pacific Healthcare, Inc dba B&B Pharmacy
Oct 7, 2015 PAPA/PHENTO (30mg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health M... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II Pacific Healthcare, Inc dba B&B Pharmacy
Oct 7, 2015 PAPA/PHENTO (15mg/0.8333mg/ml) Injection, 5 mL vial, Rx, B & B Health Mart Ph... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II Pacific Healthcare, Inc dba B&B Pharmacy
Oct 7, 2015 Testosterone prop. 200 mg/ml Injection, 10 mL vial, Rx, B & B Health Mart Pha... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II Pacific Healthcare, Inc dba B&B Pharmacy
Oct 7, 2015 Testosterone Cypionate 250 mg/mL Injection, 10 mL vial, Rx, B & B Health Mart... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II Pacific Healthcare, Inc dba B&B Pharmacy
Oct 7, 2015 PGE 20mcg/ml Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflowe... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II Pacific Healthcare, Inc dba B&B Pharmacy
Oct 7, 2015 PAPA/PGE1/PHENTO (22.5mg/8.33mcg/0.833mg/ml) Injection, 10 mL vial, Rx, B & B... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II Pacific Healthcare, Inc dba B&B Pharmacy
Oct 7, 2015 Stanozolol 200 mg/ml Injection, 20 mL vial, Rx, B & B Health Mart Pharmacy, B... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II Pacific Healthcare, Inc dba B&B Pharmacy
Oct 7, 2015 PAPA+PGE1+PHENTO (30mg/20mcg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B &... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II Pacific Healthcare, Inc dba B&B Pharmacy
Oct 7, 2015 PAPA/PGE1/PHENTO (15mg/5mcg/0.5mg/ml) Injection, 5 mL and 10 mL vials, Rx, B ... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II Pacific Healthcare, Inc dba B&B Pharmacy
Oct 7, 2015 PAPA/PGE1/PHENTO (30mg/40mcg/1mg/ml) Injection, 10 mL vial, Rx, B & B Health ... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II Pacific Healthcare, Inc dba B&B Pharmacy
Oct 7, 2015 PAPA/PGE1/PHENTO (35mg/12mcg/1.5mg/ml), Injection, 10 mL vial, Rx, B & B Heal... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II Pacific Healthcare, Inc dba B&B Pharmacy
Oct 7, 2015 PAPA/PGE1/PHENTO (30mg/50mcg/0.5mg/ml), Injection, 10 mL vial, Rx, B & B Heal... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II Pacific Healthcare, Inc dba B&B Pharmacy
Oct 7, 2015 Nandrolone 200 mg/ml Injection, 10 mL and 20 mL vials, Rx, B & B Health Mart ... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II Pacific Healthcare, Inc dba B&B Pharmacy
Oct 6, 2015 TRI-MIX 20MCG+0.5MG+15MG/ML, 10 mL vial, Rx only, Park Compounding Pharmacy 2... Lack of Assurance of Sterility: all sterile compounded products within expiry Class II Chen Shwezin, Inc. dba Park Compounding Pharmacy
Oct 6, 2015 METHYLCOBALAMIN 1000MCG/ML, 10mL vial, Rx only, Park Compounding Pharmacy 280... Lack of Assurance of Sterility: all sterile compounded products within expiry Class II Chen Shwezin, Inc. dba Park Compounding Pharmacy
Oct 6, 2015 CAFFEINE + SODIUM BENZOATE 500MG/ML, 35 mL vial, Rx only, Park Compounding Ph... Lack of Assurance of Sterility: all sterile compounded products within expiry Class II Chen Shwezin, Inc. dba Park Compounding Pharmacy

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.