Medicines, 2016
Shortlist up to four to read them side by side.
1,254 medicine recalls FDA’s Enforcement Report published in 2016, newest first; 18,075 in all since 2012.
FDA’s medicine recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 6, 2026.
1,254of 1,254 medicine recallsshown with your filters
The list
- Medicine recall Provocholine Pre-diluted Set II Stability data does not support expiry. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Provocholine Pre-diluted Set II Stability data does not support expiry. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Provocholine Pre-diluted Set II Stability data does not support expiry. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Provocholine Pre-diluted Set II Stability data does not support expiry. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Levofloxacin Tablets USP, 500 mg Failed Dissolution Specifications: Unexplained low out of specification results for dissolution. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall MEROPENEM in NS Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNorth Carolina and Virginia
- Medicine recall CUBICIN (daptomycin) in NS Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNorth Carolina and Virginia
- Medicine recall SOD CHLORIDE (Sodium Chloride) Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNorth Carolina and Virginia
- Medicine recall Parenteral Amino Acid Infusion 10% Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNorth Carolina and Virginia
- Medicine recall CEFAZOLIN, Packaged as a) 625MG in 6.2ML Syringes, b) 2GM in 20ML Syringes, c) 1GM in 50ML Homepumps, d) 2GM… Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNorth Carolina and Virginia
- Medicine recall Milrinone in 0.45% NS, Packaged as a) 52MG in 65ML Homepumps, b) 80MG in 100ML Homepumps, c) 92MG in 115ML… Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNorth Carolina and Virginia
- Medicine recall SOLUMEDROL (methylprednisolone succinate) 1GM in NS Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNorth Carolina and Virginia
- Medicine recall INTRALIPID (fat emulsion) Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNorth Carolina and Virginia
- Medicine recall POTASSIUM CHLORIDE in D 5 1/2NS Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNorth Carolina and Virginia
- Medicine recall Dextrose-NaCl (D5-1/2NS) in NS Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNorth Carolina and Virginia
- Medicine recall CEFTRIAXONE in NS Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNorth Carolina and Virginia
- Medicine recall DOBUTAMINE HCL in D5W Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNorth Carolina and Virginia
- Medicine recall VANCOMYCIN HCL Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNorth Carolina and Virginia
- Medicine recall ONDANSETRON HCL 8MG Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNorth Carolina and Virginia
- Medicine recall HYDROMORPHONE HCL Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNorth Carolina and Virginia
- Medicine recall GANCICLOVIR in NS Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNorth Carolina and Virginia
- Medicine recall ASCORBIC ACID 500MG/Syringe Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNorth Carolina and Virginia
- Medicine recall Invanz (ertapenem) Injection Recon Soln in NS Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNorth Carolina and Virginia
- Medicine recall CEFEPIME, Packaged a) 1GM in 50ML Homepumps, b) 2GM in 100ML Homepumps, and c) 12GM in 600ML Homepumps, Rx… Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNorth Carolina and Virginia
- Medicine recall ZOSYN (pipericillin/tazobactam) in NS Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNorth Carolina and Virginia
- Medicine recall MORPHINE 10MG/ML in NS Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNorth Carolina and Virginia
- Medicine recall PENICILLIN in D5W Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNorth Carolina and Virginia
- Medicine recall FLUCONAZOLE IN NACL 400MG in NS Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNorth Carolina and Virginia
- Medicine recall Ampicillin/Sulbactam 12GM in NS Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNorth Carolina and Virginia
- Medicine recall Nafcillin 2GM in NS Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNorth Carolina and Virginia
- Medicine recall Lactated Ringers Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNorth Carolina and Virginia
- Medicine recall Cancidas (caspofungin acetate) 58.4MG in NS Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNorth Carolina and Virginia
- Medicine recall AZACTAM (aztreonam) 2GM in NS Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNorth Carolina and Virginia
- Medicine recall CLINDAMYCIN 120MG in NS, Package Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNorth Carolina and Virginia
- Medicine recall Solu-Cortef (hydrocortisone) 1MG in NS Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNorth Carolina and Virginia
- Medicine recall GENTAMICIN, Packaged as a) 70MG in 70ML Homepumps, b) 80MG in 80ML Homepumps, and c) 375MG in a 75ML… Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNorth Carolina and Virginia
- Medicine recall Tobramycin 120MG Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNorth Carolina and Virginia
- Medicine recall Dextrose-5% Lactated Ringers Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNorth Carolina and Virginia
- Medicine recall MYCAMINE (micafungin sodium) 150MG Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNorth Carolina and Virginia
- Medicine recall Cyclopentolate Hydrochloride Ophthalmic Solution USP, 1% Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert. Class IIIFDA’s classFeb 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 3, 2016ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Tropicamide Ophthalmic Solution USP, 0.5% Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert. Class IIIFDA’s classFeb 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 3, 2016ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Tropicamide Ophthalmic Solution USP, 1% Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert. Class IIIFDA’s classFeb 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 3, 2016ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Baclofen 1 mg/ml Lack of Assurance of Sterility Class IIFDA’s classJan 27, 2016in FDA’s Enforcement ReportArizonathe one state its words name PublishedJan 27, 2016ClassClass IIStatusTerminatedWhereArizona
- Medicine recall IT Custom Compound (BC) Baclofen 2000 mcg/ml, Clonidine 2 mcg/ml 40 ml PF syringe, FOR INTRATHECAL USE ONLY Lack of Assurance of Sterility Class IIFDA’s classJan 27, 2016in FDA’s Enforcement ReportArizonathe one state its words name PublishedJan 27, 2016ClassClass IIStatusTerminatedWhereArizona
- Medicine recall Lindane Lotion, USP 1%, For External use Only Super-Potent Drug: Out of Specification Assay test results were reported for stability samples. Class IIIFDA’s classJan 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 27, 2016ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg DOUBLE STRENGTH, 100-count bottle Presence of foreign substance -This recall has been intiated due to the presence of a polyethylene piece on the finished product. Class IIFDA’s classJan 27, 2016in FDA’s Enforcement ReportMississippithe one state its words name PublishedJan 27, 2016ClassClass IIStatusTerminatedWhereMississippi
- Medicine recall Baclofen USP powder Presence of Foreign Substance Class IIFDA’s classJan 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phentermine Hydrochloride Capsules, USP, 15 mg Failed impurities/Degradation specifications: out of specification results for individual unknown and total impurity at the 12th month room temperature… Class IIIFDA’s classJan 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 27, 2016ClassClass IIIStatusTerminatedWhereNationwide
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Drug recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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