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 ¿Topicort (desoximetasone) Cream USP, 0.05% Subpotent Drug Class IIIFDA’s classJun 8, 2016in FDA’s Enforcement Report9 statesnamed in where it went PublishedJun 8, 2016ClassClass IIIStatusTerminatedWhereCalifornia, Connecticut, Massachusetts, Maryland, New Jersey, New York, Oklahoma, Texas and Washington
- Medicine recall Ceftriaxone for Injection USP, 250 mg, Single Use Vial CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications. Class IIIFDA’s classJun 8, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 8, 2016ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Ceftriaxone for Injection USP, 500 mg, Single Use Vial CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications. Class IIIFDA’s classJun 8, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 8, 2016ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Ceftriaxone for Injection USP, 1 g, Single Use Vial (NDC 68180-633-01) CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications. Class IIIFDA’s classJun 8, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 8, 2016ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Ceftriaxone for Injection USP, 2 g, Single Use Vial (NDC 68180-644-01) CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications. Class IIIFDA’s classJun 8, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 8, 2016ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Ceftriaxone Sodium (Sterile) USP active pharmaceutical ingredient, DMF No. 15931 CGMP Deviations: active pharmaceutical ingredient intermediates failed specifications. Class IIIFDA’s classJun 8, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 8, 2016ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Zoloft (sertraline HCl) tablets, 100 mg*, 30 count bottles Failed Tablet/Capsule Specifications: thick tablets exceeding specifications were found. Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Sclerosol Intrapleural Aerosol (sterile talc powder), Intrapleural administration, 4 g Canister Defective Delivery System: Defective stem valve causes leakage of the propellant in the spray canister delivering no drug or an inadequate amount of the drug… Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Amikacin Sulfate injection USP,1 gm/4 mL Presence of Particulate Matter: particulate matter identified as glass in one vial. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 1, 2016ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall LIPO ESCULTURA 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)Jun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall 0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags Lack of Assurance of Sterility: potential for leaking containers which lacks the assurance of sterility. Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall 0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags Presence of Particulate Matter: identified as cardboard. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 1, 2016ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Metronidazole Injection USP, 500 mg per 100 mL Presence of Particulate Matter: identified as a cloth fiber. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 1, 2016ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall CLINIMIX E 5/15 sulfite-free Presence of Particulate Matter: identified as dried skin. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 1, 2016ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall 8.4% Sodium Bicarbonate Injection, USP 50mEq Presence of Particulate Matter: particulate matter identified as an insect in one vial. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IStatusOngoingWhereNationwide
- Medicine recall OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL Failed Impuities/Degradation Specifications Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL Failed Impuities/Degradation Specifications Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Linezolid Injection, 600 mg/300 mL Single use container bags (NDC 0703-9060-31) Lack of Assurance of Sterility: Due to potential for leaking bags. Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Avastin (Bevacizumab) 2 mg/0.08 mL syringe, Office Administration Only, AmEx Pharmacy, 1515 Elizabeth St… Non-Sterility: Product tested positive for bacterial contamination. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Avastin (Bevacizumab) 1.25 mg/0.05 mL syringe, Office Administration Only, AmEx Pharmacy, 1515 Elizabeth St… Non-Sterility: Product tested positive for bacterial contamination. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Morphine Sulfate 0.5 mg/mL, Preservative Free Super-Potent Drug: Out of specification for potency results (high) were obtained for one lot of morphine sulfate Inj. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 1, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 1, 2016ClassClass IStatusTerminatedWhereIllinois and Indiana
- Medicine recall Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.3 mg (a) 2 prefilled auto injectors + 1 trainer (NDC… Defective Delivery System; potential to have inaccurate dosage delivery FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.15 mg (a) 2 prefilled auto injectors + 1 trainer (NDC… Defective Delivery System; potential to have inaccurate dosage delivery FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall ORIS (chlorhexidine gluconate), oral rinse, 0.12% Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate. Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Chlorhexidine gluconate, oral rinse, 0.12% Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate. Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall PerioRx (chlorhexidine gluconate), oral rinse, 0.12% Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate. Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Smart Lipo Dietary Supplement capsules, 800 mg Marketed without an approved NDA/ANDA - Product contains undeclared sibutramine, desmethylsibutramine and phenolphthalein. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Smart Lipo Dietary Supplement capsules, 900 mg Marketed without an approved NDA/ANDA - Product contains undeclared sibutramine, desmethylsibutramine and phenolphthalein. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Pink Bikini Strong Formula capsules, 750 mg Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Shorts on The Beach Strong Formula by Pink Bikini capsules, 750 mg Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Shorts on The Beach Golden Edition by Pink Bikini, 800 mg Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Pink Bikini capsules, (all colors and all strengths) Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine, Phenolphthalein and/or Diclofenac. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Shorts on the Beach capsules, (all colors and all strengths) Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine, Phenolphthalein and/or Diclofenac. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Black Ant, packaged in Big Box (20 small boxes / 4 capsules per box / 80 capsules total), Distributed by: R… Marketed Without An Approved NDA/ANDA FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Herb Viagra, packaged in Big Box (20 small boxes / 4 capsules per box / 80 capsules total), Distributed by: R… Marketed Without An Approved NDA/ANDA FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Real Skill, packaged in 20 small boxes / 4 capsules per box / 80 capsules total, Distributed by: R Thomas… Marketed Without An Approved NDA/ANDA FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Stree Overlord Marketed Without An Approved NDA/ANDA FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Weekend Prince Marketed Without An Approved NDA/ANDA FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall African Black Ant Marketed Without An Approved NDA/ANDA FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Bull, packaged in CASE (10 packs / 3 capsules per can / 30 capsules), Distributed by: R Thomas Marketing,… Marketed Without An Approved NDA/ANDA FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Bull’s Genital Marketed Without An Approved NDA/ANDA FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Zhong Hua Niu Bian Marketed Without An Approved NDA/ANDA FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall African Superman Marketed Without An Approved NDA/ANDA FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Bigger Longer More Time More Sperms Marketed Without An Approved NDA/ANDA FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Black Ant King Marketed Without An Approved NDA/ANDA FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Black Storm, packaged in SMALL BOX (6 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467 Marketed Without An Approved NDA/ANDA FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Germany Niubian Marketed Without An Approved NDA/ANDA FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Happy Passengers Marketed Without An Approved NDA/ANDA FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 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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