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 ACETAMINOPHEN REGULAR-STRENGTH PAIN RELIEVER tablets, 325 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
- Medicine recall Akttive High Performance Fat Burner Gold dietary supplement capsules, 30-count bottle Marketed Without An Approved NDA/ANDA: Dietary supplements contains undeclared sibutramine, desmethylsibutramine and phenolphthalein based on FDA sampling. 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 IStatusOngoingWhereNationwide
- Medicine recall Menthocin Patch with Lidocaine-Strong (Menthol 5%, Capsaicin 0.0375%, Methyl Salicylate 20%, Lidocaine 0.5%) Marketed without an approved NDA/ANDA Class IIFDA’s classFeb 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 24, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall TEARS Naturale FREE (dextran 70 and hypromellose 2910) lubricant eye drops, 1% and 0.3%, Preservative Free,… Lack of Assurance of Sterility: Some single-use vials may be filled with water rather than the product solution and the firm cannot guarantee the sterility of… Class IIFDA’s classFeb 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 24, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall APEXXX tablets, 300 mg 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)Feb 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 24, 2016ClassClass IStatusOngoingWhereNationwide, and Florida named
- Medicine recall Magnesium Sulfate in Water for Injection Labeling: Incorrect Barcode: Primary bag labeling may be mislabeled with the wrong barcode which scans in as heparin sodium. 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
- Medicine recall Vitamin Supplement (Vial) D3, (cholecalciferol (vit D3)/lipoic acid/ubiquinol/… Superpotent Drug: The vitamin supplement contains an extremely high level of vitamin D3 (Cholecalciferol). FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 24, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 24, 2016ClassClass IStatusOngoingWhereGeorgia and New York
- Medicine recall Rhino 7 3000, 6 count bottles Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredients; desmethyl carbondenafil and dapoxetine. 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
- Medicine recall Rhino 7 Platinum 3000, Single Blister Packs Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredients; desmethyl carbondenafil and dapoxetine. 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
- Medicine recall Rhino 7 3000, 6 count Bottle Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredients; desmethyl carbondenafil and dapoxetine. 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
- Medicine recall Rhino 7 Platinum 3000, 1 count Blister Pack Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredients; desmethyl carbondenafil and dapoxetine. 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
- Medicine recall CITRULLINE (L) Labeling: Label Mix-Up: FDA tested samples of API from Medisca, labeled as to contain L-Citrulline, and results revealed no L-Citrulline was present. 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
- Medicine recall NATUREAL BURN FAT NATURE, 30-count capsules Marketed Without an Approved NDA/ANDA: Product contains undeclared sibutramine. 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
- Medicine recall Bupivacaine, 0.25%, 450 mL, This Rx is Compounded, Abbott’s Compounding Pharmacy, Berkeley, CA 94705 Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility… Class IIFDA’s classFeb 24, 2016in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedFeb 24, 2016ClassClass IIStatusTerminatedWhereCalifornia
- Medicine recall calcium elemental, 3 mg/10 mL, 200 mL unit: This Rx is Compounded, Abbott’s Compounding Pharmacy, Berkeley,… Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility… Class IIFDA’s classFeb 24, 2016in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedFeb 24, 2016ClassClass IIStatusTerminatedWhereCalifornia
- Medicine recall Estradiol cypionate/Test cyprionate Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility… Class IIFDA’s classFeb 24, 2016in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedFeb 24, 2016ClassClass IIStatusTerminatedWhereCalifornia
- Medicine recall Folic Acid, 5 mg/mL, 30 mL unit size, refrigerate, This Rx is Compounded, Abbott’s Compounding Pharmacy,… Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility… Class IIFDA’s classFeb 24, 2016in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedFeb 24, 2016ClassClass IIStatusTerminatedWhereCalifornia
- Medicine recall Folic Acid, 10 mg/mL, 6 mL unit size, refrigerate, This Rx is Compounded, Abbott’s Compounding Pharmacy,… Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility… Class IIFDA’s classFeb 24, 2016in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedFeb 24, 2016ClassClass IIStatusTerminatedWhereCalifornia
- Medicine recall Hydroxycobalamine 30 mg/mL, 90 mL unit size, refrigerate, This Rx is Compounded, Abbott’s Compounding… Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility… Class IIFDA’s classFeb 24, 2016in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedFeb 24, 2016ClassClass IIStatusTerminatedWhereCalifornia
- Medicine recall hydroxyprogesterone in sesame 250 mg/mL, 2 mL, 5 mL, 6 mL, 8 mL unit sizes, This Rx is Compounded, Abbott’s… Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility… Class IIFDA’s classFeb 24, 2016in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedFeb 24, 2016ClassClass IIStatusTerminatedWhereCalifornia
- Medicine recall hydroxyprogesterone w/ pres Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility… Class IIFDA’s classFeb 24, 2016in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedFeb 24, 2016ClassClass IIStatusTerminatedWhereCalifornia
- Medicine recall Insulin, 70/30, 10 mL unit size, refrigerate, This Rx is Compounded, Abbott’s Compounding Pharmacy, Berkeley,… Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility… Class IIFDA’s classFeb 24, 2016in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedFeb 24, 2016ClassClass IIStatusTerminatedWhereCalifornia
- Medicine recall methylcobalamine 10 mg/mL, 10 mL and 12 mL unit sizes, refrigerate, This Rx is Compounded, Abbott’s… Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility… Class IIFDA’s classFeb 24, 2016in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedFeb 24, 2016ClassClass IIStatusTerminatedWhereCalifornia
- Medicine recall methylcobalamine 1 mg/mL, 1 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott’s Compounding… Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility… Class IIFDA’s classFeb 24, 2016in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedFeb 24, 2016ClassClass IIStatusTerminatedWhereCalifornia
- Medicine recall methylcobalamine 4 mg/mL, 5 mL and 30 mL unit sizes, refrigerate, This Rx is Compounded, Abbott’s Compounding… Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility… Class IIFDA’s classFeb 24, 2016in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedFeb 24, 2016ClassClass IIStatusTerminatedWhereCalifornia
- Medicine recall papaverine prostaglandin 30 mg/30 mcg/mL, 5 mL unit size, refrigerate, This Rx is Compounded, Abbott’s… Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility… Class IIFDA’s classFeb 24, 2016in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedFeb 24, 2016ClassClass IIStatusTerminatedWhereCalifornia
- Medicine recall papaverine prostaglandin 30 mg/20 mcg/mL, 10 mL unit size Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility… Class IIFDA’s classFeb 24, 2016in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedFeb 24, 2016ClassClass IIStatusTerminatedWhereCalifornia
- Medicine recall papaverine phentolamine 30 mg/1mg/mL, 5 mL and 10 mL unit size, refrigerate, This Rx is Compounded, Abbott’s… Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility… Class IIFDA’s classFeb 24, 2016in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedFeb 24, 2016ClassClass IIStatusTerminatedWhereCalifornia
- Medicine recall papaverine phentolamine, 35 mg/2.5 mg/mL Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility… Class IIFDA’s classFeb 24, 2016in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedFeb 24, 2016ClassClass IIStatusTerminatedWhereCalifornia
- Medicine recall papaverine phentolamine prostaglandin Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility… Class IIFDA’s classFeb 24, 2016in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedFeb 24, 2016ClassClass IIStatusTerminatedWhereCalifornia
- Medicine recall papaverine phentolamine prostaglandin Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility… Class IIFDA’s classFeb 24, 2016in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedFeb 24, 2016ClassClass IIStatusTerminatedWhereCalifornia
- Medicine recall papaverine phentolamine prostaglandin Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility… Class IIFDA’s classFeb 24, 2016in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedFeb 24, 2016ClassClass IIStatusTerminatedWhereCalifornia
- Medicine recall papaverine phentolamine prostaglandin Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility… Class IIFDA’s classFeb 24, 2016in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedFeb 24, 2016ClassClass IIStatusTerminatedWhereCalifornia
- Medicine recall papaverine phentolamine prostaglandin Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility… Class IIFDA’s classFeb 24, 2016in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedFeb 24, 2016ClassClass IIStatusTerminatedWhereCalifornia
- Medicine recall papaverine phentolamine prostaglandin Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility… Class IIFDA’s classFeb 24, 2016in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedFeb 24, 2016ClassClass IIStatusTerminatedWhereCalifornia
- Medicine recall papaverine phentolamine prostaglandin Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility… Class IIFDA’s classFeb 24, 2016in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedFeb 24, 2016ClassClass IIStatusTerminatedWhereCalifornia
- Medicine recall papaverine phentolamine prostaglandin Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility… Class IIFDA’s classFeb 24, 2016in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedFeb 24, 2016ClassClass IIStatusTerminatedWhereCalifornia
- Medicine recall papaverine phentolamine prostaglandin Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility… Class IIFDA’s classFeb 24, 2016in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedFeb 24, 2016ClassClass IIStatusTerminatedWhereCalifornia
- Medicine recall papaverine phentolamine prostaglandin Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility… Class IIFDA’s classFeb 24, 2016in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedFeb 24, 2016ClassClass IIStatusTerminatedWhereCalifornia
- Medicine recall papaverine phentolamine prostaglandin Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility… Class IIFDA’s classFeb 24, 2016in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedFeb 24, 2016ClassClass IIStatusTerminatedWhereCalifornia
- Medicine recall papaverine phentolamine prostaglandin Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility… Class IIFDA’s classFeb 24, 2016in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedFeb 24, 2016ClassClass IIStatusTerminatedWhereCalifornia
- Medicine recall papaverine phentolamine prostaglandin Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility… Class IIFDA’s classFeb 24, 2016in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedFeb 24, 2016ClassClass IIStatusTerminatedWhereCalifornia
- Medicine recall papaverine phentolamine prostaglandin Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility… Class IIFDA’s classFeb 24, 2016in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedFeb 24, 2016ClassClass IIStatusTerminatedWhereCalifornia
- Medicine recall papaverine phentolamine prostaglandin Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility… Class IIFDA’s classFeb 24, 2016in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedFeb 24, 2016ClassClass IIStatusTerminatedWhereCalifornia
- Medicine recall papaverine phentolamine prostaglandin Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility… Class IIFDA’s classFeb 24, 2016in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedFeb 24, 2016ClassClass IIStatusTerminatedWhereCalifornia
- Medicine recall papaverine phentolamine prostaglandin Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility… Class IIFDA’s classFeb 24, 2016in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedFeb 24, 2016ClassClass IIStatusTerminatedWhereCalifornia
- Medicine recall papaverine phentolamine prostaglandin Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility… Class IIFDA’s classFeb 24, 2016in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedFeb 24, 2016ClassClass IIStatusTerminatedWhereCalifornia
- Medicine recall papaverine phentolamine prostaglandin Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility… Class IIFDA’s classFeb 24, 2016in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedFeb 24, 2016ClassClass IIStatusTerminatedWhereCalifornia
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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