Medicines, 2017
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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 Adenosine all strengths, all dosage forms and all packaging Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Nitroglycerin all strengths, all dosage forms and all packaging Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Nicardipine HCl all strengths, all dosage forms and all packaging Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Rocuronium Bromide all strengths, all dosage forms and all packaging Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Labetalol HCl all strengths, all dosage forms and all packaging Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Esmolol HCl all strengths, all dosage forms and all packaging Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Glycopyrrolate all strengths, all dosage forms and all packaging Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Neostigmine Methylsulfate all strengths, all dosage forms and all packaging Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Atropine Sulfate all strengths, all dosage forms and all packaging Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Betamethasone Sodium Phosphate & Betamethasone Acetate all strengths, all dosage forms and all packaging Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Famotidine HCl all strengths, all dosage forms and all packaging Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ondansetron HCl all strengths, all dosage forms and all packaging Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Bumetadine all strengths, all dosage forms and all packaging Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dexamethasone Sodium Phosphate all strengths, all dosage forms and all packaging Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dexmedetomidine HCl all strengths, all dosage forms and all packaging Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cardioplegic Solution Maintenance all strengths, all dosage forms and all packaging Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Magnesium Sulfate all strengths, all dosage forms and all packaging Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Potassium Phosphate all strengths, all dosage forms and all packaging Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sodium Phosphate all strengths, all dosage forms and all packaging Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sodium Citrate all strengths, all dosage forms and all packaging Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fentanyl Citrate with Ropivacaine HCl all strengths, all dosage forms and all packaging Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fentanyl Citrate and Bupivacaine HCl all strengths, all dosage forms and all packaging Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Optic Splash (naphazoline hydrochloride) Eye Drops Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas. Class IIFDA’s classMay 31, 2017in FDA’s Enforcement Report3 statesnamed in where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereGuam, Hawaii and Northern Mariana Islands
- Medicine recall SATO CLEAR (naphazoline hydrochloride) Redness Reliever Eye Drops Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas. Class IIFDA’s classMay 31, 2017in FDA’s Enforcement Report3 statesnamed in where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereGuam, Hawaii and Northern Mariana Islands
- Medicine recall DORAMA-NEO (naphazoline hydrochloride) Eye wash Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas. Class IIFDA’s classMay 31, 2017in FDA’s Enforcement Report3 statesnamed in where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereGuam, Hawaii and Northern Mariana Islands
- Medicine recall Children’s Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30-count bottle Failed Tablet/Capsule Specifications: out of specification results for increased tablet hardness. Class IIIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 31, 2017ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Benzonatate capsules, 200 mg, 100-count bottle Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content. Class IIIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall HYDROCORTISONE LOTION, USP, 2.5%, 2 FL OZ Superpotent Drug: above specification for the assay. Class IIIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 31, 2017ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Tarina Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets), 1… Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint… Class IIIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Norethindrone Acetate and Ethinyl Estradiol Tablets, USP, 1 mg/0.02 mg, 1 blister pack containing 21 tablets… Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint… Class IIIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Infant 25% DEXTROSE Injection, USP, 2.5 g Presence of Particulate Matter: human hair found within an internal sample syringe. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 31, 2017ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Hyland’s Baby Teething Tablets [Calcarea Phosporica 6X HPUS, Chamomilla 6X HPUS, Coffea Cruda 6X HPUS,… Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the product labels. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 31, 2017ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Hyland’s Baby Nighttime Teething Tablets [Belladonna 12X HPUS Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the product labels. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 31, 2017ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Refresh Tears (Carboxymethylcellulose Sodium Solution) 0.5%, Lubricant Eye Drops, Sterile Labeling: Not elsewhere classified; product labeling lacks a NDC number, net weight information and does not contain the Drug Facts Panel. Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Shield and Protect Moisture Barrier Cream, 1.1% Clotrimazole, Net Weight 4 oz - 115 g Anti-Fungal, Gentell,… GMP Deviations; product may not meet cGMP requirements Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall LaBri’s Body Health Atomic, 60 capsules Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IStatusTerminatedWhereNationwide
- Medicine recall 5-MTHF *10ML* MDV 5MG/ML INJ, Injection, 5mg/mL Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 5-MTHF 10ML MDV (CALIF) 5MG/ML INJ, Injection, 5mg/mL Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 5-MTHF 10ML SDV (CALIF) 5MG/ML INJ, Injection 5mg/mL Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 5-MTHF SDV 5MG/ML INJ, Injection, 5mg/mL Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ATROPINE SULFATE 0.01% OPHTH, Ophthalmic, 0.01% Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ATROPINE SULFATE 0.5% OPHTH, Ophthalmic 0.50% Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CO-Q-10 OIL 20ML MDV (CALIF) 25MG/ML INJ, Injection, 25mg/mL Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall DMPS ACID *5ML* SDV 50MG/ML INJ, Injection, 50mg/ml Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall DMSO 6.25% OPHTH., 6.25% Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall FERR GLUC/PROCAINE 10ML MDV 60/10MG/ML INJ, Injection, 60mg/10mg/mL Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall FOLIC ACID 1ML SDV 10MG/ML INJ, Injection, 10mg/mL Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall FOLINIC ACID MDV (CALIF) 5MG/ML INJ, Injection, 5mg/mL Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 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.
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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