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Browse Drug Recalls

420 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 420 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 420 FDA drug recalls in VA.

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DateProductReasonClassFirm
Sep 18, 2015 Nafcillin 2GM in NS, Packaged in 50ML Homepumps, Rx Only. SENTARA HOME HEALTH... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 Solu-Cortef (hydrocortisone) 1MG in NS, Packaged in 0.1ML Syringe, Rx Only. S... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 Invanz (ertapenem) Injection Recon Soln in NS, Packaged as a) 500MG in 50ML H... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 PENICILLIN in D5W, Packaged as a)36MU in 360ML Homepumps and b) 51MU in 510ML... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 ASCORBIC ACID 500MG/Syringe, Packaged in 1ML Syringes, Rx Only. SENTARA HOME ... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 Milrinone in 0.45% NS, Packaged as a) 52MG in 65ML Homepumps, b) 80MG in 100M... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 CEFAZOLIN, Packaged as a) 625MG in 6.2ML Syringes, b) 2GM in 20ML Syringes, c... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 AZACTAM (aztreonam) 2GM in NS, Packaged in 100ML Homepumps, Rx Only. SENTARA ... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 CLINDAMYCIN 120MG in NS, Package in 20ML Homepumps, Rx Only. SENTARA HOME HEA... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 Dextrose-5% Lactated Ringers, Packaged in 3000ML Homepumps, Rx Only. SENTARA ... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 HYDROMORPHONE HCL, Packaged as a) 2.5MG in 1ML Syringes, b) 150MG in 75ML Hom... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 Lactated Ringers, Packaged in a) 1500ML Homepumps, b) 2800ML Homepumps, and c... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 Dextrose-NaCl (D5-1/2NS) in NS, Packaged in a) 1700ML Homepumps, b) 1800ML H... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Nov 3, 2014 Forever Beautiful INFINITY, capsules, 300mg in 60-count bottles, 900 Commonwe... Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain sibutramine and phen... Class I REFA Enterprises, LLC
Nov 3, 2014 Forever Beautiful BEE POLLEN, capsules, 250mg in 60-count bottles, 900 Common... Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain sibutramine and phen... Class I REFA Enterprises, LLC
Jan 28, 2014 Hydroxyprogesterone Caproate 250mg/ml in Sesame Oil, 1 ml injectable solution... Crystallization; visible crystals from the active ingredient formed due to extreme cold temperatu... Class II RX South LLC DBA RX3 Pharmacy
Jan 22, 2013 Medi-bolic Booster Injectable (methionine 8.3 mg/mL, choline chloride 16.6 mg... CGMP Deviations: Pharmaceutical for injection was not manufactured according to Good Manufacturin... Class II RX South LLC DBA RX3 Pharmacy
Dec 18, 2012 Flanax (aluminum hydroxide, magnesium hydroxide, and simethicone) Fast Acting... Defective Container: Product lacks tamper evident breakaway band on cap. Class III Belmora LLC
Nov 19, 2012 EstroGel (estradiol gel) 0.06%, contained in 50-gr metered pumps, 1.25g/pump ... Defective Container: Pump head detaching from the canister unit upon removal of the overcap. Class III Ascend Therapeutics Inc
Sep 21, 2012 Limed Bone Gelatin, packaged in six 125 kg fiber drums and labeled in part PO... Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microb... Class II American Enterprises LLC dba Sterling Gelatin

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.