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 All hydroxyurea Products Lack of Processing Controls Class IIFDA’s classJul 13, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 13, 2016ClassClass IIStatusTerminatedWhereCalifornia, Hawaii and New Mexico
- Medicine recall All acyclovir and lidocaine Products Lack of Processing Controls Class IIFDA’s classJul 13, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 13, 2016ClassClass IIStatusTerminatedWhereCalifornia, Hawaii and New Mexico
- Medicine recall All fluconazole Products Lack of Processing Controls Class IIFDA’s classJul 13, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 13, 2016ClassClass IIStatusTerminatedWhereCalifornia, Hawaii and New Mexico
- Medicine recall All sucralfate Products Lack of Processing Controls Class IIFDA’s classJul 13, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 13, 2016ClassClass IIStatusTerminatedWhereCalifornia, Hawaii and New Mexico
- Medicine recall All doxycycline Products Lack of Processing Controls Class IIFDA’s classJul 13, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 13, 2016ClassClass IIStatusTerminatedWhereCalifornia, Hawaii and New Mexico
- Medicine recall All dyclonine Products Lack of Processing Controls Class IIFDA’s classJul 13, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 13, 2016ClassClass IIStatusTerminatedWhereCalifornia, Hawaii and New Mexico
- Medicine recall All estradiol Products Lack of Processing Controls Class IIFDA’s classJul 13, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 13, 2016ClassClass IIStatusTerminatedWhereCalifornia, Hawaii and New Mexico
- Medicine recall All ketamine and amitriptyline Products Lack of Processing Controls Class IIFDA’s classJul 13, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 13, 2016ClassClass IIStatusTerminatedWhereCalifornia, Hawaii and New Mexico
- Medicine recall All methyltestosterone Products Lack of Processing Controls Class IIFDA’s classJul 13, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 13, 2016ClassClass IIStatusTerminatedWhereCalifornia, Hawaii and New Mexico
- Medicine recall All clobetasol Products Lack of Processing Controls Class IIFDA’s classJul 13, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 13, 2016ClassClass IIStatusTerminatedWhereCalifornia, Hawaii and New Mexico
- Medicine recall All hydroquinone Products Lack of Processing Controls Class IIFDA’s classJul 13, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 13, 2016ClassClass IIStatusTerminatedWhereCalifornia, Hawaii and New Mexico
- Medicine recall All Nitro Paste (nitroglycerin) Products Lack of Processing Controls Class IIFDA’s classJul 13, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 13, 2016ClassClass IIStatusTerminatedWhereCalifornia, Hawaii and New Mexico
- Medicine recall All tacrolimus Products Lack of Processing Controls Class IIFDA’s classJul 13, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 13, 2016ClassClass IIStatusTerminatedWhereCalifornia, Hawaii and New Mexico
- Medicine recall All e2-e3-p4 Products Lack of Processing Controls Class IIFDA’s classJul 13, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 13, 2016ClassClass IIStatusTerminatedWhereCalifornia, Hawaii and New Mexico
- Medicine recall All diethylstilbestrol Products Lack of Processing Controls Class IIFDA’s classJul 13, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 13, 2016ClassClass IIStatusTerminatedWhereCalifornia, Hawaii and New Mexico
- Medicine recall All baclofen Products Lack of Processing Controls Class IIFDA’s classJul 13, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 13, 2016ClassClass IIStatusTerminatedWhereCalifornia, Hawaii and New Mexico
- Medicine recall All potassium bromide Products Lack of Processing Controls Class IIFDA’s classJul 13, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 13, 2016ClassClass IIStatusTerminatedWhereCalifornia, Hawaii and New Mexico
- Medicine recall All Malarone (atovaquone and proguanil) Products Lack of Processing Controls Class IIFDA’s classJul 13, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 13, 2016ClassClass IIStatusTerminatedWhereCalifornia, Hawaii and New Mexico
- Medicine recall Magnesium Sulfate Inj., USP 50%, 10 g/20 mL Presence of Particulate Matter: Confirmed customer complaint for the presence of particulate matter. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 13, 2016ClassClass IStatusOngoingWhereNationwide
- Medicine recall Asset BOLD Capsules, 500 mg, 60-count bottles Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 13, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Asset extreme+PLUS Capsules, 500 mg, 30-count bottles Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 13, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall EVOLVE BEE POLLEN Capsules, 250mg, 60-count bottles Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 13, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Infinity Capsules, 500 mg, 30-count bottle Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 13, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Jenesis Capsules, 350 mg, 60-count bottles Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 13, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall La’ Trim Plus Capsules, 350 mg, 60-count bottles Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 13, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Oasis Capsules, 500mg, 45-count bottles Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 13, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Prime Capsules, 500mg, 60-count bottles Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 13, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall SlimeX-15 Capsules, 15 mg, 30-count bottles Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 13, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall SLIM TRIM U Capsules, 250mg, 60-count bottles Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 13, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Ultimate Formula Capsules, 250mg, 48-count bottles Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 13, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall XCEL Capsules, 300 mg, 60-count bottles Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 13, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall XCEL ADVANCED Capsules, 350mg, 60-count bottles Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 13, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall ZI XIU TANG BEAUTY FACE & FIGURE Capsules, 250 mg, 60-count bottles Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 13, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall fentaNYL citrate Subpotent Drug FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 13, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Atropine Sulfate Injection Solution, 0.4 mg/1 mL Subpotent Drug FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 13, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall fentaNYL Citrate 1 MCG/mL Subpotent Drug FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 13, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall fentaNYL CITRATE 25 mcg/mL Subpotent Drug FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 13, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall fentaNYL citrate Subpotent Drug FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 13, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall fentaNYL CITRATE 4 MCG/mL Subpotent Drug FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 13, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall fentaNYL Citrate 50 mcg/mL in Sterile Water for Injection Subpotent Drug FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 13, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall HEParin Sodium 0.5 USP UNITS/mL Stability Data Does Not Support Expiry Class IIFDA’s classJul 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HEPARIN Sodium Stability Data Does Not Support Expiry Class IIFDA’s classJul 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall LIDocaine HCl 1% BUFFERED WITH SODIUM BICARBONATE Injection Subpotent Drug Class IIFDA’s classJul 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Midazolam HCl Subpotent Drug Class IIFDA’s classJul 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall MIDAZolam HCl 0.1 mg/mL Subpotent Drug Class IIFDA’s classJul 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall MIDAZOLAM HCl Subpotent Drug Class IIFDA’s classJul 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Zero Xtreme High Performance Fat Burner capsules, 30-count bottle Marketed Without an Approved NDA/ANDA: FDA sampling and analysis confirmed the presence of sibutramine and desmethylsibutramine. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 13, 2016ClassClass IStatusOngoingWhereNationwide
- Medicine recall TESTOSTERONE CYPIONATE 200mg/ml, 1ML MDV, Vital Care Compounder, Hattiesburg, MS Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vial on all containers. Class IIFDA’s classJul 13, 2016in FDA’s Enforcement ReportMississippithe one state its words name PublishedJul 13, 2016ClassClass IIStatusTerminatedWhereMississippi
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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