Medicines, 2017
Shortlist up to four to read them side by side.
1,073 medicine recalls FDA’s Enforcement Report published in 2017, 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.
1,073of 1,073 medicine recallsshown with your filters
The list
- Medicine recall Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets Failed Stability Specifications Class IIIFDA’s classNov 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 22, 2017ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Clolar (clofarabine) 20 mg/20 mL Labeling: Incorrect or Missing Package Insert. Class IIIFDA’s classNov 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 22, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL Presence of Particulate Matter Class IIFDA’s classNov 22, 2017in FDA’s Enforcement Report5 statesnamed in where it went PublishedNov 22, 2017ClassClass IIStatusTerminatedWhereMississippi, North Carolina, Ohio, Texas and Utah
- Medicine recall Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% Failed Impurities/Degradation Specifications. Class IIIFDA’s classNov 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 22, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Lumigan (bimatoprost ophthalmic solution) 0.01%, 2.5 mL bottle Failed Impurities/Degradation Specifications. Class IIIFDA’s classNov 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 22, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Estriol, For Prescription Compounding cGMP Deviations: lack of quality assurance at the API manufacturer. Class IIFDA’s classNov 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hydromorphone HCl 0.5 mg per mL Superpotent drug: out of specification result for potency Class IIFDA’s classNov 22, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 22, 2017ClassClass IIStatusTerminatedWhereCalifornia and Illinois
- Medicine recall Urin D/S Tablets Methenamine 81.6 mg, Sodium Biphosphate 40.8 mg, Phenyl Salicylate 36.2 mg, Methylene Blue… Superpotent Drug: Subpotent Drug. Class IIFDA’s classNov 22, 2017in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedNov 22, 2017ClassClass IIStatusTerminatedWherePuerto Rico
- Medicine recall Meclizine hydrochloride tablets USP, 12.5 mg, 100 count HDPE bottle Marketed without an approved NDA/ANDA: Bottles were released prior to final approval. Class IIIFDA’s classNov 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 22, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Betadine Solution Swabstick Povidone-Iodine Solution USP, 10% Dist.by: Purdue Products LP Subpotent Drug: The laminate used to make the pouches was reversed such that the aluminum layer was in contact with the product causing an exothermic reaction… Class IIFDA’s classNov 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Succinylcholine 20 MG/ML INJ (QUELICIN), 10 ML Vials Labeling: Incorrect or Missing Lot and/or Exp Date; incorrect expiration date on the labeling of the outer poly bag Class IIFDA’s classNov 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Doan’s Pain Relieving Cream with 4% Lidocaine Plus Menthol, (lidocaine 4%, menthol 1%) Labeling: Incorrect or Missing Lot and/or Exp Date; lot number on the secondary packaging doesnt match the lot number printed on the bottle Class IIIFDA’s classNov 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Duloxetine Delayed-release Capsules USP, 20 mg, 50 Capsules Failed Impurities/Degradation Specifications: slightly elevated levels of phthalic acid. Class IIFDA’s classNov 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 8, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Clofarabine injection, 20 mg/20 mL, 20 mL Single-Use Vial Labeling: Incorrect or Missing Package Insert: authorized generic product was packaged with the incorrect insert for the brand name product Clolar… Class IIIFDA’s classNov 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 8, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Carbamazepine Oral Suspension USP, 100 mg/5 mL, 5 mL Unit Dose Cups (NDC 68094-301-59) Subpotent Drug: low out of specification results. Class IIIFDA’s classNov 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 8, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall A1 Slim, Dietary Supplement Beautifully Slim, capsule, 350 mg, 30-count bottle, A1 Slim LLC Pearland TX… Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sibutramine, phenolphthalein, and n-desmethyl sibutramine, making… Class IIFDA’s classNov 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 8, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall SUCcinylcholine 20 mg per mL, Total Volume 10 mL in single-dose syringe, (SUCcinylcholine 200 mg / 10 ml) Lack Of Assurance Of Sterility. Class IIFDA’s classNov 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 8, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HYDROmorphone HCL 1 mg per mL Lack Of Assurance Of Sterility. Class IIFDA’s classNov 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 8, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HYDROmorphone HCl 20 mcg / mL BUPIvacaine HCl 0.075% Lack Of Assurance Of Sterility. Class IIFDA’s classNov 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 8, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentanyl as citrate 2 mcg per mL BUPIvacaine HCl 0.125% (Total FentaNYL Dose 500 mcg/250 mL) Lack Of Assurance Of Sterility. Class IIFDA’s classNov 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 8, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL as citrate 2 mcg / mL, ROPIVacaine HCl 0.1%, Total Fentanyl Dose Lack Of Assurance Of Sterility. Class IIFDA’s classNov 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 8, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall morphine sulfate 1 mg per mL Lack Of Assurance Of Sterility. Class IIFDA’s classNov 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 8, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall oxyTOCIN 30 units added to Lactated Ringers 500 mL Bag Lack Of Assurance Of Sterility. Class IIFDA’s classNov 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 8, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PHENYLephrine HCl 100 mcg per mL Lack Of Assurance Of Sterility. Class IIFDA’s classNov 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 8, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Calcium GLUCOnate 2 g added to 0.9% Sodium Chloride 50 mL Bag, Each bag contains 9.3 mEq Ca++ Lack Of Assurance Of Sterility. Class IIFDA’s classNov 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 8, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ROCuronium Bromide 10 mg per mL, 5 mL Fill in single dose syringe Lack Of Assurance Of Sterility. Class IIFDA’s classNov 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 8, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dutasteride and Tamsulosin HCl Capsules, 0.5 mg/ 0.4 mg Failed dissolution specifications; all lots within expiry are being recalled due to out of specification dissolution results. Class IIFDA’s classNov 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 8, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Diltiazem HCL 125 mg added to 0.9% Sodium Chloride 100 ml bag, 125 mL bag Lack of Assurance of Sterility. Class IIFDA’s classNov 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 1, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ePHEDrine sulfate 50 mg/10 ml syringes Lack of Assurance of Sterility. Class IIFDA’s classNov 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 1, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL citrate 1000 mcg Lack of Assurance of Sterility. Class IIFDA’s classNov 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 1, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentanyl citrate (PF) 1100 mcg Lack of Assurance of Sterility. Class IIFDA’s classNov 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 1, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hydromorphone HCl 10 mg Lack of Assurance of Sterility. Class IIFDA’s classNov 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 1, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Magnesium sulfate 10 Gm added to Lactated Ringer’s 250 mL bags Lack of Assurance of Sterility. Class IIFDA’s classNov 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 1, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Midazolam HCL 100 mg Lack of Assurance of Sterility. Class IIFDA’s classNov 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 1, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Norepinephrine Bitartrate 8 mg added to 0.9% Sodium Chloride 250 mL in a bag Lack of Assurance of Sterility. Class IIFDA’s classNov 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 1, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall OXYtocin 30 units added to 0.9% Sodium Chloride 500 mL bag Lack of Assurance of Sterility. Class IIFDA’s classNov 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 1, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ropivacaine HCL (PF) 0.2% Lack of Assurance of Sterility. Class IIFDA’s classNov 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 1, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Succinylcholine 200 mg/10 mL Syringe Lack of Assurance of Sterility. Class IIFDA’s classNov 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 1, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall VANCOmycin 1.5 grams added to 0.9% Sodium Chloride 500 mL bag Lack of Assurance of Sterility. Class IIFDA’s classNov 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 1, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall VANCOmycin 1.25 grams added to 0.9% Sodium Chloride 500 mL bag Lack of Assurance of Sterility. Class IIFDA’s classNov 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 1, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Norepinephrine Bitartrate16 mg added to 0.9% Sodium Chloride 250 mL bag Lack of Assurance of Sterility. Class IIFDA’s classNov 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 1, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ChloraPrep OneStep (Clear) Labeling; Label Mixup; the immediate package is labeled incorrectly as Chloroprep Onestep (Clear), however, the correct label should be Chloroprep with Tint… Class IIFDA’s classNov 1, 2017in FDA’s Enforcement Report5 statesnamed in where it went PublishedNov 1, 2017ClassClass IIStatusTerminatedWhereIllinois, Missouri, Pennsylvania, Tennessee and Virginia
- Medicine recall Intralipid 20%, A 20% I.V Temperature Abuse: A portion of this product lot was exposed to subfreezing temperatures, which is outside of the acceptable storage range listed on the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedNov 1, 2017ClassClass IStatusTerminatedWhereNationwide, and California and Nevada named
- Medicine recall PIYANPING Anti-Itch (hydrocortisone) Lotion, 1% Incorrect Product Formulation: product contains dexamethasone instead of hydrocortisone. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 1, 2017ClassClass IStatusTerminatedWhereNationwide
- Medicine recall MAN OF STEEL capsules, 3000mgs/grain, 1-count packets Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sildenafil, an FDA approved drug for the treatment of erectile… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 1, 2017ClassClass IStatusTerminatedWhereNationwide
- Medicine recall AndroGel (testosterone gel) 1.62%, 88 gm metered-dose pump, 20.25 mg of testosterone per pump actuation, 60… Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions. Class IIIFDA’s classNov 1, 2017in FDA’s Enforcement ReportArizonathe one state its words name PublishedNov 1, 2017ClassClass IIIStatusTerminatedWhereArizona
- Medicine recall AndroGel (testosterone gel) 1.62%, 40.5mg Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions. Class IIIFDA’s classNov 1, 2017in FDA’s Enforcement ReportArizonathe one state its words name PublishedNov 1, 2017ClassClass IIIStatusTerminatedWhereArizona
- Medicine recall Oxytocin 10 units added to 1000 mL Lactated Ringer’s Injection USP Subpotent Drug Class IIFDA’s classNov 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 1, 2017ClassClass 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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