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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 901–920 of 17,898 drug recalls

Drug Recall Ongoing Historical recordClass II

EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-880-02.

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
CGMP Deviations; potential temperature excursions due to transit delays
Recall initiated
April 21, 2025
Reported by FDA
July 30, 2025
Distribution
Within the U.S - OH, VA, FL.

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Drug Recall Ongoing Historical recordClass II

PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-710-21

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
CGMP Deviations; potential temperature excursions due to transit delays
Recall initiated
April 21, 2025
Reported by FDA
July 30, 2025
Distribution
Within the U.S - OH, VA, FL.

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Drug Recall Terminated Historical recordClass II

clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, NDC# 68180-492-01

by Lupin Pharmaceuticals Inc.

Reason
Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.
Recall initiated
June 27, 2025
Reported by FDA
July 30, 2025
Distribution
Nationwide.

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Drug Recall Completed Historical recordClass III

Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML vial per carton, Rx Only, Imprimis NJOF, LLC, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-733-05.

by Imprimis NJOF, LLC

Reason
Sub-Potent Drug: Subpotent assay results during stability testing.
Recall initiated
July 9, 2025
Reported by FDA
July 30, 2025
Distribution
Nationwide in the USA

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Drug Recall Completed Historical recordClass II

Epinephrine Lidocaine HCL, 0.25mg/mL and 7.5 mg/mL, 20x1 mL Vials per carton, Rx Only, Imprimis NJOF, 1705 Route 46 West, Unit 6B Ledgewood, NJ, 07852 NDC: 71384-641-01

by Imprimis NJOF, LLC

Reason
Sub-Potent Drug: Subpotent assay results during stability testing.
Recall initiated
July 9, 2025
Reported by FDA
July 30, 2025
Distribution
Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Shave and Skincare Power Stick Original Nourishing Invisible Protection Roll-On Antiperspirant/Deodorant, 1.8 oz./ 53 mL, A.P Deauville, LLC, PA 18040, NDC# 42913-040-00 UPC Code 815195018224

by A.P. Deauville, LLC

Reason
CGMP Deviations
Recall initiated
July 10, 2025
Reported by FDA
July 23, 2025
Distribution
U.S. Nationwide

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Drug Recall Ongoing Historical recordClass II

Beauty & Skincare Power Stick original nourishing invisible protection roll-on Antiperspirant/Deodorant Spring Fresh, 1.8 oz./53 mL, A.P Deauville, LLC, PA 18040, NDC# 42913-039-00, UPC Code 815195018194

by A.P. Deauville, LLC

Reason
CGMP Deviations
Recall initiated
July 10, 2025
Reported by FDA
July 23, 2025
Distribution
U.S. Nationwide

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Drug Recall Ongoing Historical recordClass II

Power Stick for her PH Balanced Roll-On Antiperspirant Deodorant with Powder Fresh Scent, 1.8 oz./53 mL, A.P Deauville, LLC, PA 18040, NDC# 42913-038-00, UPC Code 815195019313

by A.P. Deauville, LLC

Reason
CGMP Deviations
Recall initiated
July 10, 2025
Reported by FDA
July 23, 2025
Distribution
U.S. Nationwide

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Drug Recall Ongoing Historical recordClass II

Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ 07054, NDC 67877-262-18

by Ascend Laboratories, LLC

Reason
CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Recall initiated
July 9, 2025
Reported by FDA
July 23, 2025
Distribution
US Nationwide.

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Drug Recall Ongoing Historical recordClass II

Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ 07054, NDC 67877-261-18

by Ascend Laboratories, LLC

Reason
CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Recall initiated
July 9, 2025
Reported by FDA
July 23, 2025
Distribution
US Nationwide.

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Drug Recall Ongoing Historical recordClass II

Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles, Rx only, Mfg for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, Manufactured by: Lupin Limited Nagpur-441 108, INDIA, NDC 68180-519-01

by Lupin Pharmaceuticals Inc.

Reason
Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg.
Recall initiated
June 20, 2025
Reported by FDA
July 23, 2025
Distribution
Product was distributed nationwide within the United States.

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Drug Recall Ongoing Historical recordClass II

PERIPHERAL PARENTERAL NUTRITION, Compounded Sterile Preparation, Refrigerated Injection, Rx Only, Single Dose Injection, a) 1440 mL bag, b) 1700 mL bag, Central Admixture Pharmacy Services, Inc, Los Angeles, 13128 Imperial Hwy, Santa Fe Spr., CA 90870.

by Central Admixture Pharmacy Services, Inc (CAPS) Los Angeles

Reason
Lack of Processing Controls; prescriptions were compounded in an ISO-5 area where it was identified that a daily cleaning step was not sufficiently documented.
Recall initiated
July 1, 2025
Reported by FDA
July 23, 2025
Distribution
CA

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Drug Recall Ongoing Historical recordClass II

Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Manufactured for: Qualient Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands, NDC 82009-022-10. NDC 82009-022-10

by Dr. Reddy's Laboratories, Inc.

Reason
Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
Recall initiated
June 30, 2025
Reported by FDA
July 23, 2025
Distribution
USA Nationwide

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Drug Recall Ongoing Historical recordClass II

Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-456-17

by ACCORD HEALTHCARE, INC.

Reason
Subpotent Drug: Assay below the approved specification
Recall initiated
June 20, 2025
Reported by FDA
July 23, 2025
Distribution
Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-455-17

by ACCORD HEALTHCARE, INC.

Reason
Subpotent Drug: Assay below the approved specification
Recall initiated
June 20, 2025
Reported by FDA
July 23, 2025
Distribution
Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-452-17

by ACCORD HEALTHCARE, INC.

Reason
Subpotent Drug: Assay below the approved specification
Recall initiated
June 20, 2025
Reported by FDA
July 23, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-451-17

by ACCORD HEALTHCARE, INC.

Reason
Subpotent Drug: Assay below the approved specification
Recall initiated
June 20, 2025
Reported by FDA
July 23, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 90-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-448-15

by ACCORD HEALTHCARE, INC.

Reason
Subpotent Drug: Assay below the approved specification
Recall initiated
June 20, 2025
Reported by FDA
July 23, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-447-17

by ACCORD HEALTHCARE, INC.

Reason
Subpotent Drug: Assay below the approved specification
Recall initiated
June 20, 2025
Reported by FDA
July 23, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 90-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-447-15

by ACCORD HEALTHCARE, INC.

Reason
Subpotent Drug: Assay below the approved specification
Recall initiated
June 20, 2025
Reported by FDA
July 23, 2025
Distribution
Nationwide in the USA

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.