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 Baclofen 5000 mcg/ml, vol. 20 ml syringe Lack of Assurance of Sterility Class IIFDA’s classMar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hydromorphone HCL 10 mg/ml/Baclofen 460 mcg/ml/Bupivacaine HCL, vol. 40 ml syringe Lack of Assurance of Sterility Class IIFDA’s classMar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Morphine Sulfate 0.5 mg/ml/Baclofen 1000 mcg/ml/, vol. 20 ml syringe Lack of Assurance of Sterility Class IIFDA’s classMar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hydromorphone 12 mg/ml/Baclofen 450 mcg/ml, vol. 20 ml, syringe Lack of Assurance of Sterility Class IIFDA’s classMar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Morphine Sulfate 9 mg/ml/Sufentanil Cit 180 mcg/ml/Bupivacaine HCL 33 mg/ml, vol. 20 ml vial Lack of Assurance of Sterility Class IIFDA’s classMar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sufentanil Cit 1000 mcg/ml/Baclofen 300 mcg/ml, vol. 20 ml syringe Lack of Assurance of Sterility Class IIFDA’s classMar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Morphine Sulfate 0.6 mg/ml, vol. 200 ml syringe Lack of Assurance of Sterility Class IIFDA’s classMar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Morphine Sulfate 20 mg/ml/Bupivacaine HCL 11.3 mg/ml, vol. 40 ml syringe Lack of Assurance of Sterility Class IIFDA’s classMar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Morphine Sulfate 50 mg/ml/Bupivacaine HCL 24 mg/ml, vol. 20 ml syringe Lack of Assurance of Sterility Class IIFDA’s classMar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hydromorphone HCL 10 mg/ml/Bupivacaine HCL 30 mg/ml, vol. 20 ml syringe Lack of Assurance of Sterility Class IIFDA’s classMar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Morphine Sulfate 10 mg/ml, vol. 20 ml syringe Lack of Assurance of Sterility Class IIFDA’s classMar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Baclofen 2000 mcg/ml, vol. 20 ml syringe Lack of Assurance of Sterility Class IIFDA’s classMar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hydromorphone HCL 20 mg/ml/Bupivacaine HCL 40 mg/ml, vol. 20 ml syringe Lack of Assurance of Sterility Class IIFDA’s classMar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hydromorphone HCL 25 mg/ml, vol. 40 ml syringe Lack of Assurance of Sterility Class IIFDA’s classMar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hydromorphone HCL 10 mg/ml/Fentanyl Citrate 0.15 mg/ml, vol. 40 ml syringe Lack of Assurance of Sterility Class IIFDA’s classMar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hydromorphone HCL 10 mg/ml, vol. 40 ml syringe Lack of Assurance of Sterility Class IIFDA’s classMar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hydromorphone HCL 2 mg/ml, vol. 20 ml syringe Lack of Assurance of Sterility Class IIFDA’s classMar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Morphine Sulfate 1.5 mg/ml, vol. 20 ml syringe Lack of Assurance of Sterility Class IIFDA’s classMar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fentanyl Citrate 1.275 mg/ml/Baclofen 150 mcg/ml/Bupivacaine HCL 20 mg/ml/ Clonidine HCL 450 mcg/ml, vol. 40… Lack of Assurance of Sterility Class IIFDA’s classMar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hydromorphone HCL 1 mg/ml, vol. 22 ml syringe Lack of Assurance of Sterility Class IIFDA’s classMar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hydromorphone HCL 25 mg/ml/Bupivacaine HCL 4 mg/ml, vol. 40 ml syringe Lack of Assurance of Sterility Class IIFDA’s classMar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hydromorphone HCL 10 mg/ml/Bupivacaine HCL 4 mg/ml, vol. 20 ml syringe Lack of Assurance of Sterility Class IIFDA’s classMar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Morphine Sulfate 11 mg/ml, vol. 20 ml syringe Lack of Assurance of Sterility Class IIFDA’s classMar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hydromorphone HCL 7 mg/ml/Bupivacaine HCL 11.2 mg/ml, vol. 40 ml syringe Lack of Assurance of Sterility Class IIFDA’s classMar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sufentanil Cit 200 mcg/ml/Clonidine HCL 1600 mcg/ml, vol. 42 ml syringe Lack of Assurance of Sterility Class IIFDA’s classMar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Morphine Sulfate 20 mg/ml, vol. 42 ml syringe Lack of Assurance of Sterility Class IIFDA’s classMar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Morphine Sulfate 0.5 mg/ml, vol. 20 ml syringe Lack of Assurance of Sterility Class IIFDA’s classMar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hydromorphone HCL 0.5 mg/ml, vol. 20 ml syringe Lack of Assurance of Sterility Class IIFDA’s classMar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sufentanil Cit 50 mcg/ml/Clonidine HCL 1 mcg/ml/Bupivacaine HCL 5 mg/ml, vol. 20 ml syringe Lack of Assurance of Sterility Class IIFDA’s classMar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Scrub-Stat 4 (chlorhexidine gluconate) Foam Forming Solution, 4% Subpotent drug Class IIIFDA’s classMar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 16, 2016ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Atorvastatin Calcium 10 mg, 10 tablets per blister,100-count package Failed Impurities/Degradation Specifications Class IIIFDA’s classMar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Atorvastatin Calcium 20 mg, 10 tablets per blister,100-count package Failed Impurities/Degradation Specifications Class IIIFDA’s classMar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Atorvastatin Calcium 40 mg, 10 tablets per blister,100-count package Failed Impurities/Degradation Specifications Class IIIFDA’s classMar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Atorvastatin Calcium 80 mg, 10 tablets per blister,100-count package Failed Impurities/Degradation Specifications Class IIIFDA’s classMar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall RHINO 7 3000, 6 count Bottle Marketed without an Approved NDA/ANDA: Products contain undeclared desmethyl carbondenafil and dapoxetine. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Rhino 7 Platinum 3000, 1 count Blister Pack Marketed without an Approved NDA/ANDA: Products contain undeclared desmethyl carbondenafil and dapoxetine. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, For intramuscular injection only Presence of Particulate Matter: Glass particles found in the product after reconstitution. Class IIFDA’s classMar 9, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 9, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, For intramuscular injection only Presence of Particulate Matter: Glass particles found in the product after reconstitution. Class IIFDA’s classMar 9, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 9, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall 0.9% Sodium Chloride Irrigation, USP, 500 mL bottle PRESENCE OF PARTICULATE MATTER: Product complaint for the presence of particulate matter identified as an insect. Class IIFDA’s classMar 9, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 9, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Capecitabine tablets USP 500 mg, Cytotoxic Agent Failed Dissolution Specifications: low test results at the 18 month time-point Class IIFDA’s classMar 9, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 9, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Baclofen, 2.5 mg/mL INJ Lack of assurance of sterility Class IIFDA’s classMar 9, 2016in FDA’s Enforcement ReportTexasthe one state its words name PublishedMar 9, 2016ClassClass IIStatusTerminatedWhereTexas
- Medicine recall sulfur8 medicated LIGHT FORMULA (sulfur) anti-dandruff hair & scalp conditioner, 2% Subpotent Drug: failed at the 3 and 6 month stability time points. Class IIIFDA’s classMar 9, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 9, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Alendronate Sodium Tablets, USP, 70 mg*, 4-count blisters per carton Failed Impurities/Degradation Specifications: Observed levels of highest unknown impurity exceeding specification limit at the 3 month stability time point. Class IIFDA’s classMar 9, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 9, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall risperiDONE ORALLY DISINTEGRATING TABLETS, 2 mg, 30 Ct Bottles Failed Impurities/Degradation Specifications: Out of specification for a known degradant. Class IIIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Medicated Better Braids, La Laque (salicylic acid) Spray, 2%,12 Fl Microbial Contamination of a Non-Sterile Products: The product had a positive Staphylococcus aureus test result. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Normosol-M and 5% Dextrose (multiple electrolytes and 5% dextrose) Injection Type 1, USP, 1000 mL Single-Dose… Labeling: Incorrect or Missing Lot and/or Exp Date: Confirmed customer report of an incorrect expiration date printed on the primary container labeled… Class IIIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Triamcinolone Diacetate Injectable Suspension, 40 mg/mL, 10mL Multi-Dose Vial for Injection Labeling: Incorrect or Missing Lot and/or Exp Date: some vials may be mislabeled with an incorrect “Compounded” date, lot number, and ”Do Not Use Beyond ”… Class IIIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall ACETAMINOPHEN EXTRA-STRENGTH PAIN RELIEVER tablets, 500 mg, 100-count bottle Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets mislabeled to contain 325 mg tablets. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 24, 2016ClassClass IStatusTerminatedWhereNationwide
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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