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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 1,361–1,380 of 17,937 drug recalls

Drug Recall Ongoing Historical recordClass 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 recordClass 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 recordClass 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 recordClass 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 recordClass 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 recordClass 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 recordClass 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

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Drug Recall Terminated Historical recordClass 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

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Drug Recall Terminated Historical recordClass 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.

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Drug Recall Ongoing Historical recordClass 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.

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Drug Recall Terminated Historical recordClass III

Varithena (polidocanol injectable foam) Administration Pack, Contains: 3 silicone-free syringes, 2 compression pads, 1 Varithena Transfer Unit, 1 manometer tubing, Rx Only, Distributed by Biocompatibles Inc., a BTG International Group company. CN01114.3

by Biocompatibles UK, Ltd.

Reason
Defective Delivery System: incorrect silicone oil-free NormJect 10 mL Luer Lock Solo syringes packaged in the pack, instead of the required silicone oil-free NormJect 10 mL Luer Solo syringes (luer slip connection).
Recall initiated
August 15, 2024
Reported by FDA
December 18, 2024
Distribution
Nationwide in the USA.

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Drug Recall Terminated Historical recordClass II

Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distributed by: Lannet Company, Philadelphia, PA 19136, NDC: 0527-4661-37

by Lannett Company Inc.

Reason
Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.
Recall initiated
October 25, 2024
Reported by FDA
December 11, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

10 Irregular Pigmentation, Accelerator, Pigment Fading Activator, Only Your Rx, Nature + Science, 1 fl. oz., 30 mL Bottle, For Professional Use Only, Only YourRx Inc., Chatsworth, CA 91311, Made in USA, Onlyyourrx.com.

by Generitech Corporation

Reason
CGMP Deviations: Inconsistency in the water systems.
Recall initiated
November 22, 2024
Reported by FDA
December 11, 2024
Distribution
CA

View recall →

Drug Recall Ongoing Historical recordClass II

Cinacalcet Tablets, 90 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-461-30

by AvKARE

Reason
CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
Recall initiated
November 27, 2024
Reported by FDA
December 11, 2024
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Cinacalcet Tablets, 60 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-460-30

by AvKARE

Reason
CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
Recall initiated
November 27, 2024
Reported by FDA
December 11, 2024
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-459-30

by AvKARE

Reason
CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
Recall initiated
November 27, 2024
Reported by FDA
December 11, 2024
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30), b) 90 count NDC 57237-019-90 and c) 1000 count (NDC 57237-019-99) bottles, Distributed by: Rising Pharmaceuticals, Inc., East Brunswick, NJ

by Rising Pharma Holding, Inc.

Reason
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
Recall initiated
November 19, 2024
Reported by FDA
December 11, 2024
Distribution
Nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30), b) 90 count (NDC 57237-018-90) and c) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ

by Rising Pharma Holding, Inc.

Reason
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
Recall initiated
November 19, 2024
Reported by FDA
December 11, 2024
Distribution
Nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ NDC 57237-017-60

by Rising Pharma Holding, Inc.

Reason
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
Recall initiated
November 19, 2024
Reported by FDA
December 11, 2024
Distribution
Nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

Sunitinib Malate Capsules, 25 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-902-28

by AvKARE

Reason
Labeling: Label Mix-Up
Recall initiated
October 18, 2024
Reported by FDA
December 11, 2024
Distribution
Nationwide within the United States

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.