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 Energique, Homeopathic Remedy, Skin Irritant & Healing Support, Topical Spray, 1 fl oz bottle Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count Class IIFDA’s classJan 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Energique, Homeopathic Remedy, Muscle/Tendon Pain & Stress Relief, Topical Spray, 1 fl oz Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count Class IIFDA’s classJan 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Energique, Homeopathic Remedy, Joint Pain & Stiffness Relief, Topical Spray, 1 fl oz Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count Class IIFDA’s classJan 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Energique, Homeopathic Remedy, Shingles Pain & Ulceration Relief, Topical Spray, 1 fl oz Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count Class IIFDA’s classJan 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Energique, Homeopathic Remedy, Headache Pain & Sinus Pressure Relief, Topical Spray, 1 fl oz Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count Class IIFDA’s classJan 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Energique, Homeopathic Remedy, First Aid Pain & Trauma Relief, 1 fl oz Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count Class IIFDA’s classJan 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Bevacizumab 1.25 mg/0.05 mL Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use. Class IIFDA’s classJan 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 27, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Bevacizumab 1.25 mg/0.05 mL filled to 0.06 mL Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use. Class IIFDA’s classJan 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 27, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Bevacizumab 2 mg/0.08 mL Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use. Class IIFDA’s classJan 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 27, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Bevacizumab 2.5 mg/0.1 mL Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use. Class IIFDA’s classJan 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 27, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Bromfenac Ophthalmic Solution 0.09%, a) 2.5 mL bottles (NDC 0378-7110-35) and b) 5 mL bottles (NDC… Lack of Assurance of Sterility: Failed preservative effectiveness test Class IIFDA’s classJan 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HYDROCHLOROTHIAZIDE CAPSULES, USP, 12.5 mg, 10 cap/blister, 100-count carton Presence of Particulate Matter Class IIFDA’s classJan 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE… Failed Impurities/Degradation Specifications: High out of specification test result for impurities during stability testing. Class IIFDA’s classJan 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Domperidone BP, Active Pharmaceutical Ingredient for Prescription Compounding Penicillin Cross Contamination: Potential for products to be cross-contaminated with penicillin. Class IIFDA’s classJan 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Life-Line DOCUSATE CALCIUM Sodium Free STOOL SOFTENER 240 mg each, 100 softgels per bottle Labeling: Label mix-up. Class IIIFDA’s classJan 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 20, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Azithromycin Tablets, USP, 250 mg cGMP Deviations: This recall is a result of the original manufacturer’s recall, in which the firm did not adequately investigate customer complaints. Class IIFDA’s classJan 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Azithromycin 500 mg tablets cGMP Deviations: This recall is a result of the original manufacturer’s recall, in which the firm did not adequately investigate customer complaints. Class IIFDA’s classJan 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 5-methyltetrahydrofolate Calcium (L) (a) 1 gm Subpotent Drug Class IIIFDA’s classJan 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Magnesium Sulfate 7-Hydrate, (For Parenteral Use) USP -GenAR, 100LB, Avantor Performance Materials, Inc.,… Failed Impurities/Degradation Specifications: Out of specifications results for impurities. Class IIIFDA’s classJan 13, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedJan 13, 2016ClassClass IIIStatusTerminatedWhereCalifornia, Illinois and North Carolina
- Medicine recall EPSOM SALT(Magnesium Sulfate Heptahydrate, USP), 50 lb multi-wall bag Failed Impurities/Degradation Specifications: Level of iron exceeds the limit set by the USP monograph for it (USP limit is NMT 0.5 ug/g (ppm)). Class IIIFDA’s classJan 13, 2016in FDA’s Enforcement ReportKentuckythe one state its words name PublishedJan 13, 2016ClassClass IIIStatusTerminatedWhereKentucky
- Medicine recall Pedi MVI a) 5 mL, b) 10 mL syringe Lack of Assurance of Sterility Class IIFDA’s classJan 6, 2016in FDA’s Enforcement ReportTexasthe one state its words name PublishedJan 6, 2016ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Heparin injection, Preservative Free, a) 280 units/0.28 mL, b) 350 units/0.35 mL syringe, c) 440 units/0.44… Lack of Assurance of Sterility Class IIFDA’s classJan 6, 2016in FDA’s Enforcement ReportTexasthe one state its words name PublishedJan 6, 2016ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Vancomycin Injection in NS, Accuflo bag, a) 500 mg/NS 100 mL, b)1G/NS 100 mL, c) Vancomycin 1G/NS 250 mL, d)… Lack of Assurance of Sterility Class IIFDA’s classJan 6, 2016in FDA’s Enforcement ReportTexasthe one state its words name PublishedJan 6, 2016ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Piperacillin/Tazobactam (Zosyn) Accuflo bag, a) 18 g/NS 275 mL b) 4.5 g/NS 100 mL Accuflo Lack of Assurance of Sterility Class IIFDA’s classJan 6, 2016in FDA’s Enforcement ReportTexasthe one state its words name PublishedJan 6, 2016ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Invanz 1 g/NS 100 mL Minibag Plus Lack of Assurance of Sterility Class IIFDA’s classJan 6, 2016in FDA’s Enforcement ReportTexasthe one state its words name PublishedJan 6, 2016ClassClass IIStatusTerminatedWhereTexas
- Medicine recall L-Cysteine 800 mg Lack of Assurance of Sterility Class IIFDA’s classJan 6, 2016in FDA’s Enforcement ReportTexasthe one state its words name PublishedJan 6, 2016ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Primaxin (Imipenem-Cilastatin) 500 mg/NS 100 mL Minibag Plus Lack of Assurance of Sterility Class IIFDA’s classJan 6, 2016in FDA’s Enforcement ReportTexasthe one state its words name PublishedJan 6, 2016ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Cefazolin in Accuflo bags, a) 1g/NS 25 mL, b) 2g/NS 25 mL, c) 8g/NS 275 mL Lack of Assurance of Sterility Class IIFDA’s classJan 6, 2016in FDA’s Enforcement ReportTexasthe one state its words name PublishedJan 6, 2016ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Dextrose 5% and 0.45% Sodium Chloride with KCl 20 mEq 1000 mL Lack of Assurance of Sterility Class IIFDA’s classJan 6, 2016in FDA’s Enforcement ReportTexasthe one state its words name PublishedJan 6, 2016ClassClass IIStatusTerminatedWhereTexas
- Medicine recall 0.9% NaCl 1000 mL with Ca 4.65 meq bag Lack of Assurance of Sterility Class IIFDA’s classJan 6, 2016in FDA’s Enforcement ReportTexasthe one state its words name PublishedJan 6, 2016ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Meropenem 1 g/NS 100 mL Minibag Plus Lack of Assurance of Sterility Class IIFDA’s classJan 6, 2016in FDA’s Enforcement ReportTexasthe one state its words name PublishedJan 6, 2016ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Oxacillin 12 g/NS 270 mL-24 hr Accuflo bag Lack of Assurance of Sterility Class IIFDA’s classJan 6, 2016in FDA’s Enforcement ReportTexasthe one state its words name PublishedJan 6, 2016ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Milrinone 0.375 mcg/kg/min D5W bag a) 365 mL, b) 400 mL c) 430 mL Lack of Assurance of Sterility Class IIFDA’s classJan 6, 2016in FDA’s Enforcement ReportTexasthe one state its words name PublishedJan 6, 2016ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Ceftriaxone 2g/NS 100 mL Minibag Plus Lack of Assurance of Sterility Class IIFDA’s classJan 6, 2016in FDA’s Enforcement ReportTexasthe one state its words name PublishedJan 6, 2016ClassClass IIStatusTerminatedWhereTexas
- Medicine recall IVIG Gamunex 40 gm Lack of Assurance of Sterility Class IIFDA’s classJan 6, 2016in FDA’s Enforcement ReportTexasthe one state its words name PublishedJan 6, 2016ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Phytonadione (Vitamin K) 1 mg/0.1mL Syringe Lack of Assurance of Sterility Class IIFDA’s classJan 6, 2016in FDA’s Enforcement ReportTexasthe one state its words name PublishedJan 6, 2016ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Thiamine 100 mg Lack of Assurance of Sterility Class IIFDA’s classJan 6, 2016in FDA’s Enforcement ReportTexasthe one state its words name PublishedJan 6, 2016ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Folic Acid 1 mg/0.2 mL syringe Lack of Assurance of Sterility Class IIFDA’s classJan 6, 2016in FDA’s Enforcement ReportTexasthe one state its words name PublishedJan 6, 2016ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Sodium Ascorbate (Vitamin C) syringe, a) 500 mg/1 mL syringe, b)1000 mg/2 mL c) 800 mg/1.6 mL Lack of Assurance of Sterility Class IIFDA’s classJan 6, 2016in FDA’s Enforcement ReportTexasthe one state its words name PublishedJan 6, 2016ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Insulin Regular (Human) syringe, a)15 unit/0.15 mL, b) 24 unit/0.24mL syringe, c) 50 unit/0.5 mL Lack of Assurance of Sterility Class IIFDA’s classJan 6, 2016in FDA’s Enforcement ReportTexasthe one state its words name PublishedJan 6, 2016ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Famotidine injection syringe a) 10 mg/1 mL b) 80 mg/8 mL Lack of Assurance of Sterility Class IIFDA’s classJan 6, 2016in FDA’s Enforcement ReportTexasthe one state its words name PublishedJan 6, 2016ClassClass IIStatusTerminatedWhereTexas
- Medicine recall IVIG Gammagard injection bag, a) 13 gm, b) 20 gm, c) 73 gm Lack of Assurance of Sterility Class IIFDA’s classJan 6, 2016in FDA’s Enforcement ReportTexasthe one state its words name PublishedJan 6, 2016ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Teflaro 600 mg Lack of Assurance of Sterility Class IIFDA’s classJan 6, 2016in FDA’s Enforcement ReportTexasthe one state its words name PublishedJan 6, 2016ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Gentamicin 14.4 mg/sodium chloride 0.9% 30 mL Prefilled syringe Lack of Assurance of Sterility Class IIFDA’s classJan 6, 2016in FDA’s Enforcement ReportTexasthe one state its words name PublishedJan 6, 2016ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Clindamycin injection, Accuflo bag, a) 500 mg/NS 50 mL b) 900 mg/NS 100 mL Lack of Assurance of Sterility Class IIFDA’s classJan 6, 2016in FDA’s Enforcement ReportTexasthe one state its words name PublishedJan 6, 2016ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Nafcillin 12 gm in NS 500 mL bag Lack of Assurance of Sterility Class IIFDA’s classJan 6, 2016in FDA’s Enforcement ReportTexasthe one state its words name PublishedJan 6, 2016ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Remicade (Infliximab) injection, 5 mg/kg bag Lack of Assurance of Sterility Class IIFDA’s classJan 6, 2016in FDA’s Enforcement ReportTexasthe one state its words name PublishedJan 6, 2016ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Tobramycin 620 mg/NS 100 mL Accuflo Lack of Assurance of Sterility Class IIFDA’s classJan 6, 2016in FDA’s Enforcement ReportTexasthe one state its words name PublishedJan 6, 2016ClassClass IIStatusTerminatedWhereTexas
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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