Showing 1,461–1,480 of 18,047 drug recalls
Drug Recall
Ongoing
Historical record Class II
Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 51079-443-20 by Mylan Institutional, Inc.
Reason
Subpotent and Superpotent Drug Recall initiated
November 19, 2024 Reported by FDA
December 18, 2024 Distribution
Nationwide in the USA.
View recall →
Drug Recall
Ongoing
Historical record Class II
Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 42292-039-20 by Mylan Institutional, Inc.
Reason
Subpotent and Superpotent Drug Recall initiated
November 19, 2024 Reported by FDA
December 18, 2024 Distribution
Nationwide in the USA.
View recall →
Drug Recall
Ongoing
Historical record Class II
Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 51079-442-20 by Mylan Institutional, Inc.
Reason
Subpotent and Superpotent Drug Recall initiated
November 19, 2024 Reported by FDA
December 18, 2024 Distribution
Nationwide in the USA.
View recall →
Drug Recall
Ongoing
Historical record Class II
Dabigatran Etexilate, 150mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-475-60 by Ascend Laboratories, LLC
Reason
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit Recall initiated
December 12, 2024 Reported by FDA
December 18, 2024 Distribution
Nationwide within the United States
View recall →
Drug Recall
Ongoing
Historical record Class II
Dabigatran Etexilate, 75 mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-474-60 by Ascend Laboratories, LLC
Reason
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit Recall initiated
December 12, 2024 Reported by FDA
December 18, 2024 Distribution
Nationwide within the United States
View recall →
Drug Recall
Ongoing
Historical record Class II
Levothyroxine Sodium Tablets USP, 112 mcg, packaged in a) 90-count bottles (NDC 0378-1811-77) and b) 1000-count bottles (NDC 0378-1811-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. by Viatris Inc
Reason
Superpotent Drug and Subpotent Drug: potency failures obtained Recall initiated
November 18, 2024 Reported by FDA
December 18, 2024 Distribution
Nationwide within the United States and Puerto Rico
View recall →
Drug Recall
Ongoing
Historical record Class II
Levothyroxine Sodium Tablets USP, 100 mcg, packaged in a) 90-count bottles (NDC 0378-1809-77) and b) 1000-count bottles (NDC 0378-1809-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. by Viatris Inc
Reason
Superpotent Drug and Subpotent Drug: potency failures obtained Recall initiated
November 18, 2024 Reported by FDA
December 18, 2024 Distribution
Nationwide within the United States and Puerto Rico
View recall →
Drug Recall
Ongoing
Historical record Class II
Levothyroxine Sodium Tablets USP, 88 mcg, packaged in a) 90-count bottles (NDC 0378-1807-77) and b) 1000-count bottles (NDC 0378-1807-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. by Viatris Inc
Reason
Superpotent Drug and Subpotent Drug: potency failures obtained Recall initiated
November 18, 2024 Reported by FDA
December 18, 2024 Distribution
Nationwide within the United States and Puerto Rico
View recall →
Drug Recall
Ongoing
Historical record Class II
Levothyroxine Sodium Tablets USP, 75 mcg, packaged in a) 90-count bottles (NDC 0378-1805-77) and b) 1000-count bottles (NDC 0378-1805-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. by Viatris Inc
Reason
Superpotent Drug and Subpotent Drug: potency failures obtained Recall initiated
November 18, 2024 Reported by FDA
December 18, 2024 Distribution
Nationwide within the United States and Puerto Rico
View recall →
Drug Recall
Ongoing
Historical record Class II
Levothyroxine Sodium Tablets USP, 50 mcg, packaged in a) 90-count bottles (NDC 0378-1803-77) and b) 1000-count bottles (NDC 0378-1803-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. by Viatris Inc
Reason
Superpotent Drug and Subpotent Drug: potency failures obtained Recall initiated
November 18, 2024 Reported by FDA
December 18, 2024 Distribution
Nationwide within the United States and Puerto Rico
View recall →
Drug Recall
Ongoing
Historical record Class II
Levothyroxine Sodium Tablets USP, 25 mcg, packaged in a) 90-count bottles (NDC 0378-1800-77) and b) 1000-count bottles (NDC 0378-1800-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. by Viatris Inc
Reason
Superpotent Drug and Subpotent Drug: potency failures obtained Recall initiated
November 18, 2024 Reported by FDA
December 18, 2024 Distribution
Nationwide within the United States and Puerto Rico
View recall →
Drug Recall
Ongoing
Historical record Class II
Levothyroxine Sodium Tablets USP, 200 mcg, packaged in a) 90-count bottles (NDC 0378-1819-77) and b) 1000-count bottles (NDC 0378-1819-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. by Viatris Inc
Reason
Superpotent Drug and Subpotent Drug: potency failures obtained Recall initiated
November 18, 2024 Reported by FDA
December 18, 2024 Distribution
Nationwide within the United States and Puerto Rico
View recall →
Drug Recall
Ongoing
Historical record Class II
Levothyroxine Sodium Tablets USP, 175 mcg, packaged in a) 90-count bottles (NDC 0378-1817-77) and b) 1000-count bottles (NDC 0378-1817-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. by Viatris Inc
Reason
Superpotent Drug and Subpotent Drug: potency failures obtained Recall initiated
November 18, 2024 Reported by FDA
December 18, 2024 Distribution
Nationwide within the United States and Puerto Rico
View recall →
Drug Recall
Ongoing
Historical record Class II
Levothyroxine Sodium Tablets USP, 150 mcg, packaged in a) 90-count bottles (NDC 0378-1815-77) and b) 1000-count bottles (NDC 0378-1815-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. by Viatris Inc
Reason
Superpotent Drug and Subpotent Drug: potency failures obtained Recall initiated
November 18, 2024 Reported by FDA
December 18, 2024 Distribution
Nationwide within the United States and Puerto Rico
View recall →
Drug Recall
Ongoing
Historical record Class II
Levothyroxine Sodium Tablets USP, 137 mcg, packaged in a) 90-count bottles (NDC 0378-1823-77) and b) 1000-count bottles (NDC 0378-1823-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. by Viatris Inc
Reason
Superpotent Drug and Subpotent Drug: potency failures obtained Recall initiated
November 18, 2024 Reported by FDA
December 18, 2024 Distribution
Nationwide within the United States and Puerto Rico
View recall →
Drug Recall
Ongoing
Historical record Class II
Levothyroxine Sodium Tablets USP, 125 mcg, packaged in a) 90-count bottles (NDC 0378-1813-77) and b) 1000-count bottles (NDC 0378-1813-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. by Viatris Inc
Reason
Superpotent Drug and Subpotent Drug: potency failures obtained Recall initiated
November 18, 2024 Reported by FDA
December 18, 2024 Distribution
Nationwide within the United States and Puerto Rico
View recall →
Drug Recall
Ongoing
Historical record Class III
Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 43598-096-04. by Dr. Reddy's Laboratories, Inc.
Reason
Failed Impurities/Degradation Specifications Recall initiated
November 22, 2024 Reported by FDA
December 18, 2024 Distribution
U.S. Nationwide
View recall →
Drug Recall
Terminated
Historical record Class II
Hylenex recombinant (hyaluronidase) injection, 150 USP units/mL, 4x1 mL Single Dose Vials, Rx only, Manufactured for and marketed by Halozyme, Inc., 12390 El Camino Real San Diego California 92130, Distributed by Antares Pharma, Inc., Ewing, NJ NDC 18657-117-04 by Mckesson Medical-Surgical Inc. Corporate Office
Reason
cGMP Deviations: Temperature excursion Recall initiated
September 11, 2024 Reported by FDA
December 18, 2024 Distribution
Virgina
View recall →
Drug Recall
Terminated
Historical record Class II
Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets blister pack; (Acetaminophen 325mg, Dextromethorphan HBr 10 mg, Guaifenesin 200 mg, Phenylephrine HCl 5 mg); Night - 56 coated caplets blister pack; (Acetaminophen 325mg, Dextromethorphan HBr 10 mg, Doxylamine succinate 6.25 mg, Phenylephrine HCl 5 mg); Manufactured BY: LNK International, Inc. FOR: Costco Wholesale Corporation. NDC# 63981-795-81 by LNK International, Inc.
Reason
CGMP Deviations: Released product should have been rejected. Recall initiated
November 14, 2024 Reported by FDA
December 18, 2024 Distribution
Product was distributed to 1 wholesale retail customer who may have further distribute the product nationwide.
View recall →
Drug Recall
Ongoing
Historical record Class II
Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile, 15mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-513-15. by FDC Limited
Reason
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle. Recall initiated
December 5, 2024 Reported by FDA
December 18, 2024 Distribution
Distributed to one Us Distributor in NJ.
View recall →
Data last updated: October 31, 2026 ET
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 .
