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 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 progesterone/testosterone (ss oil) 0.25/20 mg/mL, 10 mL unit size, room temperature, This Rx is Compounded,… 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 testosterone cypionate, 200 mg/mL, 6 mL and 10 mL unit sizes, 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 testosterone cypionate, 100 mg/mL, 10 mL unit size, 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 papaverine phent, 25 mg/0.833 mg/mL, 20 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 Paricalcitol Capsules, 1 mcg, 30 capsules per bottle Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules. Class IIIFDA’s classFeb 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 24, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Paricalcitol Capsules, 2 mcg, 30 capsules per bottle Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules. Class IIIFDA’s classFeb 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 24, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Paricalcitol Capsules, 4 mcg, 30 capsules per bottle Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules. Class IIIFDA’s classFeb 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 24, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Ultimate Herbal Slimcap Capsules, 350 mg*, 30-count bottles, labeled Part 1 of 3, fit firm & fabulous Marketed Without An Approved NDA/ANDA: product marketed as a dietary supplement was found to be tainted with undeclared sibutramine, a previously approved… 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 fentaNYL Citrate, Preservative Free, 5 mcg per mL Subpotent Drug FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 24, 2016in FDA’s Enforcement Report7 statesnamed in where it went PublishedFeb 24, 2016ClassClass IStatusTerminatedWhereCalifornia, Colorado, Iowa, Oklahoma, Pennsylvania, Virginia and Wisconsin
- Medicine recall fentaNYL Citrate, Preservative Free, 10 mcg per 1 mL Subpotent Drug FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 24, 2016in FDA’s Enforcement Report7 statesnamed in where it went PublishedFeb 24, 2016ClassClass IStatusTerminatedWhereCalifornia, Colorado, Iowa, Oklahoma, Pennsylvania, Virginia and Wisconsin
- Medicine recall Pramipexole Dihydrochloride Tablets 0.125 mg, 90 Ct Bottles Presence of Foreign Tablets/Capsules: Presence of a comingled Carbimazole 5 mg tablet. Class IIFDA’s classFeb 17, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall SyrSpend SF, a convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated to assist in… Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast. Class IIFDA’s classFeb 17, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall SyrSpend SF, Suspending Base, Grape Flavored, a convenient, sweetened, sugar-free syrup-suspending vehicle… Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast. Class IIFDA’s classFeb 17, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall SyrSpend SF, Suspending Base, a convenient, sweetened, sugar-free syrup-suspending vehicle specially… Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast. Class IIFDA’s classFeb 17, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Midazolam HCl Syrup, 10 mg/5 mL, 5 mL unit dose cups Presence of Foreign Substance: customer complaint that one unit dose cup contained a small piece of cardboard contaminant. Class IIFDA’s classFeb 17, 2016in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedFeb 17, 2016ClassClass IIStatusTerminatedWhereNew York
- Medicine recall Morphine Sulfate, 2 mg per mL Sub-potent Drug; firm’s analysis revealed subpotent result for morphine sulfate assay. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 17, 2016in FDA’s Enforcement ReportWisconsinthe one state its words name PublishedFeb 17, 2016ClassClass IStatusTerminatedWhereWisconsin
- Medicine recall Candesartan Cilexetil Tablets, 16 mg, a) 30 count (NDC 00781-5938-31) and b) 90 count (NDC 00781-5938-92)… Failed Impurities/Degradation Specifications; 9 month stability timepoint Class IIIFDA’s classFeb 17, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Candesartan Cilexetil Tablets, 16 mg, 30 Tablets Failed Impurities/Degradation Specifications; 9 month stability (manufacturer) Class IIIFDA’s classFeb 17, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Haloperidol Oral Solution, USP (Concentrate) 2 mg/mL 15 mL amber bottle Defective Container: Confirmed customer complaints of leaking bottles. Class IIFDA’s classFeb 17, 2016in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedFeb 17, 2016ClassClass IIStatusTerminatedWhereNew Jersey
- Medicine recall Lyrica (pregabalin) capsules, 50 mg, 90-count bottle FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged capsules. Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Lyrica (pregabalin) capsules, 75 mg, 90-count bottle FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged capsules. Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Clonazepam Tablets, USP, 0.5 mg, 100-count carton Failed Impurities/Degradation Specifications: out of specification result for known impurity at 6 month timepoint. Class IIIFDA’s classFeb 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 10, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Nystatin, USP Powder for Rx compounding, 50 Million Units Labeling: label error on declared strength. Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Nystatin, USP Powder for Rx compounding, 150 Million Units Labeling: label error on declared strength. Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Guaifenesin Grape liquid 100 mg/5 mL Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorrect dose markings on the dosing cups. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Guaifenesin DM Cherry liquid (guaifenesin 100 mg/5 mL and Dextromethorphan HBr 5 mg/5 mL) Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorrect dose markings on the dosing cups. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ephedrine Sulfate 5 mg/mL Stability data does not support expiry. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Epinephrine (PF) 10 mcg/mL Subpotent drug. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenylephrine (PF) 100 mcg/mL Stability data does not support expiry. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Rocuronium 10 mg/mL, injectable Stability data does not support expiry. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Succinylcholine 20 mg/mL, injectable Stability data does not support expiry. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Midazolam (PF) 0.5 mg/mL Subpotent drug. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ondansetron 2 mg/mL, injectable Stability data does not support expiry. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Midazolam (PF) 0.1 mg/mL Stability data does not support expiry. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fentanyl Citrate (PF) 50 mcg/mL, injectable Stability data does not support expiry. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Morphine Sulfate (PF) 0.5 mg/mL Stability data does not support expiry. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hydromorphone HCl 1 mg/mL Stability data does not support expiry. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Glycopyrrolate 0.2 mg/mL, injectable Stability data does not support expiry. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ketamine 100 mg/mL, injectable Stability data does not support expiry. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Morphine Sulfate (PF) 0.1 mg/mL Stability data does not support expiry. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ketamine 50 mg/mL, injectable Stability data does not support expiry. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Midazolam 1 mg/mL Stability data does not support expiry. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lidocaine HCI (PF) Inj, USP 2%, injectable Stability data does not support expiry. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Provocholine Pre-diluted Set II Stability data does not support expiry. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 3, 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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