Medicines, 2018
Shortlist up to four to read them side by side.
1,426 medicine recalls FDA’s Enforcement Report published in 2018, 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.
1,426of 1,426 medicine recallsshown with your filters
The list
- Medicine recall Levofloxacin Injection Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution. Class IIIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 15, 2018ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Levofloxacin Injection Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution. Class IIIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 15, 2018ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Levofloxacin Injection Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution. Class IIIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 15, 2018ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Valsartan/HCTZ 160/12.5 mg Tablets, 90-count jar CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereCalifornia
- Medicine recall Valsartan/HCTZ 160/25mg Tablets, 30-count jar CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereCalifornia
- Medicine recall Valsartan/HCTZ 320/25mg Tablets, 30-count jar CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereCalifornia
- Medicine recall Kit for the Preparation of Technetium Tc99m Medronate, 20mg Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Diazepam Rectal Gel, 2.5 mg, TWIN PACK that Contains two pre-filled, unit-dose, rectal delivery systems with… Labeling: Incorrect or Missing Lot and/or Exp Date: Product distributed without a lot number or expiration date on the outer carton. Class IIIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, 8 fl oz Defective Container: Tamper Evident foil seal not completely intact. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 10 mcg/mL Fentanyl Citrate (Preservative Free) CGMP deviations: Product was released while a hood certification discrepancy was being investigated. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 5 mg/mL Ephedrine Sulfate (Preservative Free) CGMP deviations: Product was released while a hood certification discrepancy was being investigated. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 10 mg/mL Rocuronium Bromide (Preservative Free) 5 mL BD Syringe, PharMEDium Services, LLC. CGMP deviations: Product was released while a hood certification discrepancy was being investigated. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lidocaine 2.5% and Prilocaine Cream, 2.5%. 30g tube Failed Impurities/Degredation Specifications: Out of Specification results for an unknown impurity was found during routine stability testing at 12 months. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Testosterone 200 mg Pellet Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect expiration date on label Class IIIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Emergency First Aid Eyewash (Purified Water 98.3%) CGMP Deviations Class IIFDA’s classAug 15, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereCalifornia and New York
- Medicine recall Eyewash Purified water 98.3%, Ophthalmic Solution CGMP Deviations Class IIFDA’s classAug 15, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereCalifornia and New York
- Medicine recall Morphine Sulfate 1 mg/mL CADD 25 mL Lack of sterility assurance. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportTexasthe one state its words name PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Ascorbic Acid 500 mg/mL 100 mL vial Lack of sterility assurance. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportTexasthe one state its words name PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Ascorbic Acid 500 mg/mL 500 mL TPN Lack of sterility assurance. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportTexasthe one state its words name PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereTexas
- Medicine recall B-Complex Rx only. packaged in a) 100 mL bag b) 100 ml MDV vial. Compounded Guardian Pharmacy Services, 7920… Lack of sterility assurance. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportTexasthe one state its words name PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereTexas
- Medicine recall EDTA Disodium 30 mg/mL PF Lack of sterility assurance. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportTexasthe one state its words name PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Glutathione 200 mg/mL 100ml Lack of sterility assurance. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportTexasthe one state its words name PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Glycopyrrolate 0.2 mg/mL 2ml Lack of sterility assurance. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportTexasthe one state its words name PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Hyaluronidase 150 units/mL 1ml Lack of sterility assurance. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportTexasthe one state its words name PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Hyaluronidase 150 units/mL 1ml Lack of sterility assurance. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportTexasthe one state its words name PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Magnesium Sulfate 200 mg/mL, 100ml Lack of sterility assurance. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportTexasthe one state its words name PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Medroxyprogesterone 150 mg/mL 5ml Lack of sterility assurance. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportTexasthe one state its words name PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Methylene Blue 10 mg/mL 1ml Lack of sterility assurance. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportTexasthe one state its words name PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Fentanyl Citrate 50 mcg/mL 2ml Lack of sterility assurance. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportTexasthe one state its words name PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Ropivacaine HCl 2 mg/mL 400 mL Lack of sterility assurance. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportTexasthe one state its words name PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Ropivacaine HCl 2 mg/mL 550 mL Lack of sterility assurance. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportTexasthe one state its words name PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Ropivacaine HCl 2 mg/mL 750 mL Lack of sterility assurance. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportTexasthe one state its words name PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Cefazolin 2 Gm/20 mL 20 ml Lack of sterility assurance. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportTexasthe one state its words name PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Glutathione 200 mg/mL 100 ml Lack of sterility assurance. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportTexasthe one state its words name PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Lidocaine 3% 10 ml Lack of sterility assurance. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportTexasthe one state its words name PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Glutathione 200 mg/mL 50 ml MDV Lack of sterility assurance. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportTexasthe one state its words name PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Methylcobalamin 1000 mcg/mL 100 mL Lack of sterility assurance. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportTexasthe one state its words name PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereTexas
- Medicine recall MIC “B” COMBO LIPOTROPIC 50 ml Lack of sterility assurance. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportTexasthe one state its words name PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Phenol 6% with Glycerin Inj 10 ml Lack of sterility assurance. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportTexasthe one state its words name PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Omega-3-Acid Ethyl Esters Capsules USP, 1 gram* 120-count bottle API material used in the manufacturing of the product did not receive regulatory approval prior to release. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg / 50 mcg per spray Presence of foreign substance: Potential for glass in the neck area of the glass bottles. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Blissful Remedies Red Maeng Da, 100% Mitragyna Speciosa capsule, 50-count Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Blissful Remedies, 4 Hour Chill, Slow Motion Blend, Herbal Shot. 1.93 Fluid Oz Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, 12mL bottle Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Blissful Remedies Gold Series Ultra Enhanced Indo, 50 capsule Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Blissful Remedies Kratom+CBD CBD infused Maeng Da, capsules 50-count Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Potassium Citrate Extended-Release Tablets, USP, 15 mEq, 100-count bottles Failed Tablet/Capsule Specifications: Tablet breakage Class IIFDA’s classAug 8, 2018in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedAug 8, 2018ClassClass IIStatusTerminatedWherePuerto Rico
- Medicine recall Potassium Citrate Extended-Release Tablets, USP, 10 mEq, 100-count bottles Failed Tablet/Capsule Specifications: Tablet breakage Class IIFDA’s classAug 8, 2018in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedAug 8, 2018ClassClass IIStatusTerminatedWherePuerto Rico
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.”
Your shortlist0 of 4
Add one more to compare.