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 Xcellerator (product not labeled) Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 15, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 15, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall CEFTRIAXONE for Injection USP, 250mg/vial CGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufacture the final API. Class IIIFDA’s classJun 15, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 15, 2016ClassClass IIIStatusTerminatedWhereGeorgia and Indiana
- Medicine recall CHLORHEXIDINE GLUCO. 0.12% ORAL RINSE Failed Impurity/Degradation Specifications: Out of specifications for unknown impurity. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement Report4 statesnamed in where it went PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereCalifornia, North Dakota, Pennsylvania and Tennessee
- Medicine recall Potassium CHLORide added to 5% Dextrose Injection, 20 mEq 250 mL Bag, PharMEDium Services, LLC, 6100 Global… Labeling: Not Elsewhere Classified: Potassium Chloride was printed on Potassium Phosphate label stock thereby having both names on the label of a 250 mL bag of… Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNew York
- Medicine recall Coppertone SUNSCREEN LOTION, CLEARLY SHEER, BROAD SPECTRUM SPF 50, 5 FL OZ Labeling; Product Contains Undeclared API (Oxybenzone) Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 17-0H PROGESTERONE 250MG/ML Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNevadathe one state its words name PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNevada
- Medicine recall ALPHA LIPOIC ACID 25MG/ML Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNevadathe one state its words name PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNevada
- Medicine recall ATROPINE SULFATE 0.5% Ophthalmic Drops Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNevadathe one state its words name PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNevada
- Medicine recall ESTRADIOL CYPIONATE 10 MG/ML Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNevadathe one state its words name PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNevada
- Medicine recall ESTRADIOL VALERATE 10MG/ML Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNevadathe one state its words name PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNevada
- Medicine recall ESTRADIOL VALERATE 20MG/ML Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNevadathe one state its words name PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNevada
- Medicine recall ESTRADIOL VALERATE 40MG/ML Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNevadathe one state its words name PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNevada
- Medicine recall GENTAMICIN 15 MG/ML Ophthalmic Solution, Sterile Droppers Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNevadathe one state its words name PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNevada
- Medicine recall GLUTATHIONE 100MG/ML Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNevadathe one state its words name PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNevada
- Medicine recall GLUTATHIONE 200MG/ML Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNevadathe one state its words name PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNevada
- Medicine recall 1-HCG 1000 IU/ML Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNevadathe one state its words name PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNevada
- Medicine recall 1-HCG 2000 IU/ML Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNevadathe one state its words name PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNevada
- Medicine recall HCG/METHYLCOBALAMIN/FOLIC ACID,1000IU/5MG/0.4MG/ML Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNevadathe one state its words name PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNevada
- Medicine recall Hydrogen Peroxide 3% Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNevadathe one state its words name PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNevada
- Medicine recall LEVOCARNITINE 100MG/ML Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNevadathe one state its words name PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNevada
- Medicine recall L-GLUT/L-ARG/L-CARN Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNevadathe one state its words name PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNevada
- Medicine recall M.l.C. 25MG/50MG/25MG/ML Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNevadathe one state its words name PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNevada
- Medicine recall M.I.C. /MB12/B6/DEXPLAN/L-CARN, 25MG/50MG/25MG/10MG/10MG/ML Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNevadathe one state its words name PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNevada
- Medicine recall M.l.C. Methyl B12, 25 MG/50MG/25MG/1 MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy… Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNevadathe one state its words name PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNevada
- Medicine recall MB 12/HXB 12/FA/P5P/(LIDO 0.1 %), 2MG/2MCi/20MG/6.5MG/ML Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNevadathe one state its words name PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNevada
- Medicine recall M.l.C./B5/B6 25 MG/50MG/25MG/10MG/10MG/ML Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNevadathe one state its words name PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNevada
- Medicine recall METHYLCOBALAMIN 12.5MG/ML Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNevadathe one state its words name PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNevada
- Medicine recall METHYLCOBALAMIN 1 MG/ML Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNevadathe one state its words name PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNevada
- Medicine recall METHYLCOBALAMIN 5MG/ML Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNevadathe one state its words name PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNevada
- Medicine recall METHYLCOBALAMIN/FOLIC ACID Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNevadathe one state its words name PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNevada
- Medicine recall MYERS’ COCKTAIL Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNevadathe one state its words name PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNevada
- Medicine recall PHENYLEPHERINE 0.5% Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNevadathe one state its words name PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNevada
- Medicine recall PHOSPHATIDYLCHOLINE/DEOXYCHOLIC ACID- 5%/4.75% Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNevadathe one state its words name PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNevada
- Medicine recall QUAD-MIX #1, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNevadathe one state its words name PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNevada
- Medicine recall QUAD-MIX #2, packaged in 5mL vial, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNevadathe one state its words name PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNevada
- Medicine recall QUAD-MIX #4 (MOD) Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNevadathe one state its words name PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNevada
- Medicine recall SUPER TRI-MIX #1 Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNevadathe one state its words name PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNevada
- Medicine recall SUPER TRI-MIX #4 Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNevadathe one state its words name PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNevada
- Medicine recall TESTOSTERONE CYPIONATE 100MG/ML Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNevadathe one state its words name PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNevada
- Medicine recall TESTOSTERONE CYPIONATE 10MG/ML Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNevadathe one state its words name PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNevada
- Medicine recall TESTOSTERONE CYPIONATE 150MG/ML Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNevadathe one state its words name PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNevada
- Medicine recall TESTOSTERONE CYPIONATE 175MG/ML Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNevadathe one state its words name PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNevada
- Medicine recall TESTOSTERONE CYPIONATE 200MG/ML Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNevadathe one state its words name PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNevada
- Medicine recall TRI-MIX # 1, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNevadathe one state its words name PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNevada
- Medicine recall TRI-MIX # 2, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNevadathe one state its words name PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNevada
- Medicine recall TRI-MIX # 3, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNevadathe one state its words name PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNevada
- Medicine recall TRI-MIX # 4, packaged in 5 mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNevadathe one state its words name PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNevada
- Medicine recall TRI-MIX # 5, packaged in 5 mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNevadathe one state its words name PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNevada
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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