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Browse Drug Recalls

34 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 34 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 34 FDA drug recalls.

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DateProductReasonClassFirm
Sep 18, 2015 MORPHINE 10MG/ML in NS, Packaged in a) 150ML Homepumps and b) 250ML Homepumps... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 CEFTRIAXONE in NS, Packaged as a) 1GM in 50ML Homepumps, b) 2GM in 100ML Home... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 CUBICIN (daptomycin) in NS, Packaged as a) 350MG in 7ML Syringes, b)365MG in ... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 FLUCONAZOLE IN NACL 400MG in NS, Packaged in 200ML Homepumps, Rx Only. SENTAR... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 POTASSIUM CHLORIDE in D 5 1/2NS, Packaged in a) 40 mEq KCL/LITER 1000ML Homep... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 CEFEPIME, Packaged a) 1GM in 50ML Homepumps, b) 2GM in 100ML Homepumps, and c... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 ONDANSETRON HCL 8MG, Packaged in 100ML Homepumps. Rx Only. SENTARA HOME HEALT... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 MEROPENEM in NS, Packaged as a) 1000MG in 250ML Homepumps, and b) 2GM in 100M... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 Parenteral Amino Acid Infusion 10%, Packaged in a) 780ML Homepumps, b) 1000ML... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 INTRALIPID (fat emulsion), Packaged in a) 27ML Homepumps, b) 125ML Homepumps,... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 GENTAMICIN, Packaged as a) 70MG in 70ML Homepumps, b) 80MG in 80ML Homepumps,... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 DOBUTAMINE HCL in D5W, Packaged as a) 240MG in 60ML Homepumps and b) 1520MG i... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 SOLUMEDROL (methylprednisolone succinate) 1GM in NS, Packaged in 100ML Homepu... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 Cancidas (caspofungin acetate) 58.4MG in NS, Packaged in 116.8ML Homepumps, R... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 VANCOMYCIN HCL, Packaged as: a) 600MG in 120ML Homepumps, b) 750MG in 150ML H... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 ZOSYN (pipericillin/tazobactam) in NS, Packaged as a) 3.375GM in 50ML Homepum... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 MYCAMINE (micafungin sodium) 150MG, Packaged in 150ML Homepumps, Rx Only. SEN... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 Tobramycin 120MG, Packaged in 150ML Homepumps, Rx Only. SENTARA HOME HEALTH S... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 Ampicillin/Sulbactam 12GM in NS, Packaged in 600ML Homepumps, Rx Only. SENTAR... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 GANCICLOVIR in NS, Packaged as a) 320MG in 64ML Homepumps and b) 2440MG in 48... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 SOD CHLORIDE (Sodium Chloride), Packaged in a) 0.9% in 30ML Homepumps, b) 0.9... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
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

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.