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 5, 2026.
1,254of 1,254 medicine recallsshown with your filters
The list
- Medicine recall Jenesis Dietary Supplement Capsules, 350 mg, 60 count bottles Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolphthalein FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 19, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 19, 2016ClassClass IStatusTerminatedWhereNo state named
- Medicine recall Diocto Liquid (docusate sodium) 50 mg/5 mL Stool Softener Laxative, One Pint Microbial contamination of Non-Sterile Products; positive findings of Burkholderia cepacia FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Amikacin Sulfate Injection, USP, 500 mg/2 mL CGMP Deviations Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Amikacin Sulfate Injection, USP, 1 gm/4 mL CGMP Deviations Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall atropine Sulfate Injection, 0.4 mg per mL, 1 mg per 2.5 mL, 2.5 mL Total Volume in a syringe, For IV use Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall atropine Sulfate Injection, 0.4 mg per mL, 0.8 mg per 2 mL, 2 mL Total Volume in a syringe, For IV Use Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Buffered Lidocaine, 1%, In Sodium Bicarbonate 8.4%, 1 mL Total Volume in a syringe, Local anesthetic use Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Buffered Lidocaine, 2%, In Sodium Bicarbonate 8.4%, 3 mL Total Volume in a syringe, Local anesthetic use Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ePHEDrine Sulfate, 10 mg per mL, 50 mg per 5 mL Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ePHEDrine Sulfate, 10 mg per mL Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fentanyl Citrate 16.67 mcg per mL and Bupivacaine HCl 0.1667% Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL Citrate Injection, 50 mcg per mL, Preservative Free, 1 mL Total Volume in a syringe, For IV Use Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL Citrate Injection, 50 mcg per mL, Preservative Free, 1 mL Total Volume in a syringe, For IV Use Subpotent Drug and Stability Data Does Not Support Expiry: confirmed subpotency and potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL Citrate, 10 mcg per 1 mL Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL Citrate, 25 mcg per mL Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL Citrate Injection, 50 mcg per mL Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL, 5mL Total Volume in a syringe, For IV Use Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL Citrate, 5 mcg per mL, 15 mcg per 3mL Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL Citrate, 5 mcg per mL Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL Citrate, 10 mcg per mL Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL Citrate, 5 mcg per mL, 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For… Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL Citrate, 5 mcg per mL Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall glycopyrrolate, 0.2 mg per mL, 0.6 mg per 3 mL, 3 mL Total Volume in a syringe, For IV Use Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall glycopyrrolate, 0.2 mg per mL, 0.4 mg per 2 mL, 2 mL Total Volume in a syringe, For IV Use Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall glycopyrrolate, 0.2 mg per mL, 1 mg per 5 mL, 5 mL Total Volume in a syringe, For IV Use Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HEPARIN Sodium Inj Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HEPARIN Sodium Inj., USP, 5,000 USP Heparin Units per 5 mL Total Volume in a syringe, NOT FOR LOCK FLUSH,… Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HEPARIN Sodium Inj Subpotent Drug and Stability Data Does Not Support Expiry: confirmed subpotency and potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HYDROmorphone HCl, 0.2 mg per mL Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HYDROmorphone HCl, 0.5 mg per mL Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HYDROmorphone HCl, 1 mg per mL Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ketamine HCl, 10 mg per mL, 50 mg per 5 mL Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ketamine HCl, 10 mg per mL, 50 mg per 5 mL, 0.9% Sodium Chloride, 5 mL Total Volume in a syringe, For IV Use Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ketamine HCl, 10 mg per mL, 20 mg per 2 mL Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ketamine HCl Injection, 50 mg per mL, 1 mL Total Volume in a syringe, For IV Use Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ketamine HCl Injection, 50 mg per mL Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall labetalol HCl, 5 mg per mL, 20 mg per 4 mL, 4 mL total Volume in a syringe, For IV Use Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall lidocaine HCl, 0.5%, 5 mg per mL Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall lidocaine HCl, 1%, 10 mg per 1 mL, 1 mL Total Volume in a syringe Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall lidocaine HCl, 1%, 30 mg per 3 mL, 3 mL Total Volume in a syringe Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall lidocaine HCl, 1%, 10 mg per mL Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall lidocaine HCl, 1% Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall lidocaine HCl 1%, 10 mg per mL Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall lidocaine HCl, 2%, 40 mg per 2 mL, 2 mL Total Volume in a syringe Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall lidocaine HCl, 2%, Preservative Free, Total Volume 2mL Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall lidocaine HCl 2%, Preservative Free, 20 mg per mL Stability Data Does Not Support Expiry:potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall lidocaine HCl, 2%, 20 mg per mL Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
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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