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FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

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Showing 10,721–10,740 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass I

Hyland's Baby Teething Tablets [Calcarea Phosporica 6X HPUS, Chamomilla 6X HPUS, Coffea Cruda 6X HPUS, Belladonna 12X HPUS (0.0000000000003% alkaloids, calculated)] Quick-Dissolving Tablets, packaged in a) 40-count bottles (NDC 54973-3127-3) (UPC 3 54973 31273 9); b) 135-count bottles (NDC 54973-3127-1) (UPCs 3 54973 31271 5, 3 54973 31371 2, 3 54973 31481 8); and 250-count bottles (NDC 54973-3127-2) (UPCs 3 54973 31272 2, 3 54973 31521 1), Manufactured for: Hyland's, Inc., Los Angeles, CA 90061.

by Standard Homeopathic Company

Reason
Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the product labels.
Recall initiated
April 13, 2017
Reported by FDA
May 31, 2017
Distribution
Nationwide in the USA and Puerto Rico.

View recall →

Drug Recall Ongoing Historical recordClass I

Infant 25% DEXTROSE Injection, USP, 2.5 g (250 mg/mL), 10 mL Unit of Use Single-dose Syringe per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-1775-10

by Hospira Inc.

Reason
Presence of Particulate Matter: human hair found within an internal sample syringe.
Recall initiated
April 21, 2017
Reported by FDA
May 31, 2017
Distribution
Nationwide in the USA and Puerto Rico

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Drug Recall Terminated Historical recordClass III

Norethindrone Acetate and Ethinyl Estradiol Tablets, USP, 1 mg/0.02 mg, 1 blister pack containing 21 tablets (NDC 0378-7280-85), packaged in 3 pouches, each contains one blister pack of 21 tablets (NDC 0378-7280-53), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., Made in India.

by Mylan Pharmaceuticals Inc.

Reason
Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room.
Recall initiated
January 30, 2017
Reported by FDA
May 31, 2017
Distribution
Nationwide in USA

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Drug Recall Terminated Historical recordClass III

Tarina Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets), 1 blister pack containing 28 tablets (NDC 50102-128-01), packaged in 3 pouches, each pouch contains one blister pack of 28 tablets (NDC 50102-128-03), Rx only, Manufactured for: Afaxys, Inc., Charleston, SC 29403, USA, Product of India.

by Mylan Pharmaceuticals Inc.

Reason
Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room.
Recall initiated
January 30, 2017
Reported by FDA
May 31, 2017
Distribution
Nationwide in USA

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Drug Recall Terminated Historical recordClass III

Benzonatate capsules, 200 mg, 100-count bottle, Rx only, Manufactured by: Strides Shasun Limited Bangaluru -560076 India, Distributed by Strides Pharma Inc East Brunswick, NJ 08816, NDC 64380-713-06

by STRIDES PHARMA INC

Reason
Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content.
Recall initiated
May 9, 2017
Reported by FDA
May 31, 2017
Distribution
U.S.A. Nationwide

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Drug Recall Terminated Historical recordClass II

Optic Splash (naphazoline hydrochloride) Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmaceuticals CO., LTD. 1-5-27 Motoakasaka Minato-Ku Tokyo, Japan, NDC 49873-501-01.

by Sato Pharmaceutical Inc.

Reason
Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
Recall initiated
February 16, 2017
Reported by FDA
May 31, 2017
Distribution
US: Hawaii, Guam, Saipan, SPI

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Drug Recall Terminated Historical recordClass II

Fentanyl Citrate and Bupivacaine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

by Advanced Pharma Inc.

Reason
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Recall initiated
February 22, 2017
Reported by FDA
May 31, 2017
Distribution
U.S. Nationwide

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Drug Recall Terminated Historical recordClass II

Fentanyl Citrate with Ropivacaine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

by Advanced Pharma Inc.

Reason
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Recall initiated
February 22, 2017
Reported by FDA
May 31, 2017
Distribution
U.S. Nationwide

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Drug Recall Terminated Historical recordClass II

Sodium Citrate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

by Advanced Pharma Inc.

Reason
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Recall initiated
February 22, 2017
Reported by FDA
May 31, 2017
Distribution
U.S. Nationwide

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Drug Recall Terminated Historical recordClass II

Potassium Phosphate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

by Advanced Pharma Inc.

Reason
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Recall initiated
February 22, 2017
Reported by FDA
May 31, 2017
Distribution
U.S. Nationwide

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Drug Recall Terminated Historical recordClass II

Magnesium Sulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

by Advanced Pharma Inc.

Reason
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Recall initiated
February 22, 2017
Reported by FDA
May 31, 2017
Distribution
U.S. Nationwide

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Drug Recall Terminated Historical recordClass II

Cardioplegic Solution Maintenance all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

by Advanced Pharma Inc.

Reason
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Recall initiated
February 22, 2017
Reported by FDA
May 31, 2017
Distribution
U.S. Nationwide

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Drug Recall Terminated Historical recordClass II

Dexmedetomidine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

by Advanced Pharma Inc.

Reason
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Recall initiated
February 22, 2017
Reported by FDA
May 31, 2017
Distribution
U.S. Nationwide

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Drug Recall Terminated Historical recordClass II

Ondansetron HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

by Advanced Pharma Inc.

Reason
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Recall initiated
February 22, 2017
Reported by FDA
May 31, 2017
Distribution
U.S. Nationwide

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Drug Recall Terminated Historical recordClass II

Famotidine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

by Advanced Pharma Inc.

Reason
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Recall initiated
February 22, 2017
Reported by FDA
May 31, 2017
Distribution
U.S. Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Betamethasone Sodium Phosphate & Betamethasone Acetate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

by Advanced Pharma Inc.

Reason
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Recall initiated
February 22, 2017
Reported by FDA
May 31, 2017
Distribution
U.S. Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Atropine Sulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

by Advanced Pharma Inc.

Reason
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Recall initiated
February 22, 2017
Reported by FDA
May 31, 2017
Distribution
U.S. Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Neostigmine Methylsulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

by Advanced Pharma Inc.

Reason
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Recall initiated
February 22, 2017
Reported by FDA
May 31, 2017
Distribution
U.S. Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Esmolol HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

by Advanced Pharma Inc.

Reason
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Recall initiated
February 22, 2017
Reported by FDA
May 31, 2017
Distribution
U.S. Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Labetalol HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

by Advanced Pharma Inc.

Reason
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Recall initiated
February 22, 2017
Reported by FDA
May 31, 2017
Distribution
U.S. Nationwide

View recall →

Data last updated:

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.