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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 161–180 of 18,047 drug recalls

Drug Recall Ongoing 2026 recordClass II

SEMAGLUTIDE 10mg (5mg/mL), Glycine 10 mg (5mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-722-02

by Apollo Care, LLC

Reason
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Recall initiated
July 29, 2026
Reported by FDA
August 19, 2026
Distribution
Nationwide within the U.S

View recall →

Drug Recall Ongoing 2026 recordClass II

SEMAGLUTIDE 7.5mg (5mg/mL), Glycine 7.5 mg (5mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-721-01

by Apollo Care, LLC

Reason
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Recall initiated
July 29, 2026
Reported by FDA
August 19, 2026
Distribution
Nationwide within the U.S

View recall →

Drug Recall Ongoing 2026 recordClass II

SEMAGLUTIDE 5mg (1mg/mL), Glycine 25 mg (5mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202.NDC 71170-712-03

by Apollo Care, LLC

Reason
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Recall initiated
July 29, 2026
Reported by FDA
August 19, 2026
Distribution
Nationwide within the U.S

View recall →

Drug Recall Ongoing 2026 recordClass II

SEMAGLUTIDE 2.5mg (1mg/mL), Glycine 12.5 mg (5mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-711-02

by Apollo Care, LLC

Reason
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Recall initiated
July 29, 2026
Reported by FDA
August 19, 2026
Distribution
Nationwide within the U.S

View recall →

Drug Recall Ongoing 2026 recordClass II

SEMAGLUTIDE 0.9mg (0.9 mg/mL), 1 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-810-01

by Apollo Care, LLC

Reason
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Recall initiated
July 29, 2026
Reported by FDA
August 19, 2026
Distribution
Nationwide within the U.S

View recall →

Drug Recall Ongoing 2026 recordClass II

SEMAGLUTIDE 9mg (4.5 mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-822-02

by Apollo Care, LLC

Reason
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Recall initiated
July 29, 2026
Reported by FDA
August 19, 2026
Distribution
Nationwide within the U.S

View recall →

Drug Recall Ongoing 2026 recordClass II

SEMAGLUTIDE 4.5mg (0.9 mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-812-03

by Apollo Care, LLC

Reason
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Recall initiated
July 29, 2026
Reported by FDA
August 19, 2026
Distribution
Nationwide within the U.S

View recall →

Drug Recall Ongoing 2026 recordClass II

SEMAGLUTIDE 6.75mg (4.5 mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202 NDC 71170-821-01

by Apollo Care, LLC

Reason
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Recall initiated
July 29, 2026
Reported by FDA
August 19, 2026
Distribution
Nationwide within the U.S

View recall →

Drug Recall Ongoing 2026 recordClass II

SEMAGLUTIDE 2.25MG (0.9 mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202 NDC 71170-811-02

by Apollo Care, LLC

Reason
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Recall initiated
July 29, 2026
Reported by FDA
August 19, 2026
Distribution
Nationwide within the U.S

View recall →

Drug Recall Ongoing 2026 recordClass II

SEMAGLUTIDE 12.5MG (2.5MG/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-495-05

by Apollo Care, LLC

Reason
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Recall initiated
July 29, 2026
Reported by FDA
August 19, 2026
Distribution
Nationwide within the U.S

View recall →

Drug Recall Ongoing 2026 recordClass II

Diovan (valsartan) 160 mg, 90 tablets, Rx only, Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 27834, Distributed by: Novartis Pharmaceutical Corp, East Hanover, NJ 07936, NDC 0078-0359-34

by Novartis Pharmaceuticals Corporation

Reason
Failed Dissolution Specifications
Recall initiated
August 4, 2026
Reported by FDA
August 19, 2026
Distribution
US Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass II

Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Matoda, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1159-3.

by Zydus Pharmaceuticals (USA) Inc

Reason
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
Recall initiated
August 5, 2026
Reported by FDA
August 12, 2026
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing 2026 recordClass I

Cyclophosphamide for Injection, USP, 2 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018. Manufactured in Taiwan, NDC 81298-8114-1

by Sunny Pharmtech Inc.

Reason
Presence of Particulate Matter; identified as stainless steel
Recall initiated
July 17, 2026
Reported by FDA
August 12, 2026
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass I

Cyclophosphamide for Injection, USP, 1 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018. Manufactured in Taiwan, NDC 81298-8112-1

by Sunny Pharmtech Inc.

Reason
Presence of Particulate Matter; identified as stainless steel
Recall initiated
July 17, 2026
Reported by FDA
August 12, 2026
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass III

Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient specific), Compound Volume 416.8 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharmacy Services, Inc., Atlanta, 1750 Corp Dr. Ste 725, Norcross, GA 30093 (844) 903-6418

by Central Admixture Pharmacy Services Inc

Reason
Incorrect Product Formulation
Recall initiated
July 16, 2026
Reported by FDA
August 12, 2026
Distribution
GA only

View recall →

Drug Recall Ongoing 2026 recordClass II

Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC 59651-719-99

by Aurobindo Pharma USA Inc

Reason
shortfill; reports of empty capsules.
Recall initiated
July 23, 2026
Reported by FDA
August 12, 2026
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass III

Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7253-04.

by Ascend Laboratories, LLC

Reason
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Recall initiated
July 16, 2026
Reported by FDA
August 5, 2026
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass III

Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7253-68.

by Ascend Laboratories, LLC

Reason
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Recall initiated
July 16, 2026
Reported by FDA
August 5, 2026
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass III

Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7255-68.

by Ascend Laboratories, LLC

Reason
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Recall initiated
July 16, 2026
Reported by FDA
August 5, 2026
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass II

Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV, 26505 USA, Made in India, NDC 67457-386-00.

by MYLAN PHARMACEUTICALS INC

Reason
Presence of precipitate
Recall initiated
July 2, 2026
Reported by FDA
August 5, 2026
Distribution
USA 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.

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