Skip to main content
Get Alerts

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.

Filters
Recall details
Location
Date range
Clear filters

Showing 1,761–1,780 of 17,937 drug recalls

Drug Recall Ongoing Historical recordClass II

Nicardipine Hydrochloride Injection, USP 25mg/mL (2.5 mg/mL) 10 mL vials, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520, NDC 55150-183-11

by Eugia US LLC

Reason
Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Recall initiated
February 20, 2024
Reported by FDA
March 27, 2024
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing Historical recordClass II

Nicardipine Hydrochloride Injection (2.5mg/mL), US, 25mg per 10mL, 10mL Vial, Rx only, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 NDC 55150-183-10

by Eugia US LLC

Reason
Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Recall initiated
February 20, 2024
Reported by FDA
March 27, 2024
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass III

Digoxin Tablets, USP 125mcg, (0.125 mg), 1000-count bottle, Rx Only, Manufactured by: Novitium Pharma LLC., 70 Lake Drive, East Windsor, New Jersey 08520, NDC 70954-201-20

by Novitium Pharma LLC

Reason
Cross Contamination with Other Products:(mycophenolate mofetil).
Recall initiated
March 4, 2024
Reported by FDA
March 27, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Telmisartan Tablets, USP 40mg, Rx Only, 30 Tablets per bottle, Manufactured by: Micro Labs Limited Goa-403 722, INDIA, Manufactured for: Micro Labs USA Inc., Somerset, NJ 08873, NDC 42571-227-30.

by Micro Labs Limited

Reason
Failed Stability Specifications: Out of specification for blend uniformity.
Recall initiated
February 9, 2024
Reported by FDA
March 20, 2024
Distribution
Puerto Rico, TN, RI

View recall →

Drug Recall Ongoing Historical recordClass II

Broncochem Cold & Tea (acetaminophen, phenylephrine, HCl, chlorpheniramine maleate), packaged in 13g sachets, 25 sachets per box, Made in the Dominican Republic Exclusively for Global Corporation Inc, Boca Raton, FL 33187 USA, NDC 65131-097-12

by Global Corporation

Reason
Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.
Recall initiated
February 16, 2024
Reported by FDA
March 20, 2024
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing Historical recordClass II

Broncochem Cold & Flu Syrup Kids (acetaminophen, guaifenesin, phenylephrine HCl), packaged in 120 mL bottles, Made in Dominican Republic Exclusively for Global Corporation Inc, Boca Raton, FL 33187 USA, NDC 65131-098-44

by Global Corporation

Reason
Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.
Recall initiated
February 16, 2024
Reported by FDA
March 20, 2024
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Tobramycin for Injection, USP, 1.2 grams per Pharmacy Bulk Package, Rx Only, For Intravenous Use, PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520, Carton NDC 55150-470-06, Vial NDC 55150-470-01.

by Eugia US LLC

Reason
Failed Stability Specification: Water determination was found not complying with specification.
Recall initiated
February 22, 2024
Reported by FDA
March 20, 2024
Distribution
Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

hyalogic For Dry Eyes, HylaTears", Lubricant Eye Drops, 0.67 FL OZ (20mL) bottle, Manufactured for hyalogic, 610 NW Platte Valley Dr., Riverside, MO 64150

by Optikem International, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
February 29, 2024
Reported by FDA
March 20, 2024
Distribution
Product distributed Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

TRP Natural Eyes Red Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-158-15.

by Optikem International, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
February 29, 2024
Reported by FDA
March 20, 2024
Distribution
Product distributed Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

TRP Natural Eyes Pink Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-013-15.

by Optikem International, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
February 29, 2024
Reported by FDA
March 20, 2024
Distribution
Product distributed Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

TRP Natural Eyes Aging Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-027-15.

by Optikem International, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
February 29, 2024
Reported by FDA
March 20, 2024
Distribution
Product distributed Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

TRP Natural Eyes Floaters Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-098-15.

by Optikem International, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
February 29, 2024
Reported by FDA
March 20, 2024
Distribution
Product distributed Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

TRP Eye strain Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-172-15.

by Optikem International, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
February 29, 2024
Reported by FDA
March 20, 2024
Distribution
Product distributed Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

TRP Natural Eyes Dryness Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-178-15.

by Optikem International, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
February 29, 2024
Reported by FDA
March 20, 2024
Distribution
Product distributed Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

TRP Eye Twitching Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-040-15.

by Optikem International, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
February 29, 2024
Reported by FDA
March 20, 2024
Distribution
Product distributed Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

TRP Blur Relief, Sterile Eye Drops, Homeopathic 0.5 FL OZ (15mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-002-11.

by Optikem International, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
February 29, 2024
Reported by FDA
March 20, 2024
Distribution
Product distributed Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

TRP Natural Eyes Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-032-15.

by Optikem International, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
February 29, 2024
Reported by FDA
March 20, 2024
Distribution
Product distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA 02420, NDC 82584-002-15

by Thea Pharma, Inc.

Reason
Lack of Assurance of Sterility: Out of specification for volume and compromised container closure.
Recall initiated
March 5, 2024
Reported by FDA
March 20, 2024
Distribution
Product was distributed nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Bicillin L-A (Penicillin G Benzathine) 1.2, MMU / 2 mL Injection Prefilled Syringe 2 mL, Rx only, Mfg: Pfizer Pharmaceuticals, NDC 60793-0701-10

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
cGMP Deviations: Products were stored outside the drug label specifications.
Recall initiated
February 7, 2024
Reported by FDA
March 20, 2024
Distribution
Product was distributed to three direct accounts in NM, AZ and UT.

View recall →

Drug Recall Terminated Historical recordClass II

Infuvite Adult Multiple vitamins injection, single-dose vial 5mL, Rx only, MFG: Baxter Healthcare Corp., NDC 54643-5649-01

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
cGMP Deviations: Products were stored outside the drug label specifications.
Recall initiated
February 7, 2024
Reported by FDA
March 20, 2024
Distribution
Product was distributed to three direct accounts in NM, AZ and UT.

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.