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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 141–160 of 17,898 drug recalls

Drug Recall Ongoing 2026 recordClass II

Sensipar (cinacalcet) Tablets, 30mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799, Made in Japan. NDC 55513-073-30

by Amgen, Inc.

Reason
CGMP Deviations
Recall initiated
June 4, 2026
Reported by FDA
July 1, 2026
Distribution
Nationwide within the United States

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Drug Recall Ongoing 2026 recordClass II

Corlanor (ivabradine) tablets, 5 mg, packaged in a) 14 tablets bottles (NDC 55513-800-99), and b) 60 tablet bottles (NDC 55513-800-60), Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy.

by Amgen, Inc.

Reason
Presence of Foreign Substance.
Recall initiated
June 4, 2026
Reported by FDA
July 1, 2026
Distribution
Nationwide within the United States

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Drug Recall Ongoing 2026 recordClass II

Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Ajanta Pharma Limited, India, Marketed by: Ajanta Pharma USA Inc. Bridgewater, NJ 08807, NDC 27241-120-04.

by Ajanta Pharma USA Inc

Reason
CGMP Deviations
Recall initiated
May 28, 2026
Reported by FDA
July 1, 2026
Distribution
U.S. Nationwide

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Drug Recall Ongoing 2026 recordClass II

Carton Label: MAJOR, Methylergonovine Maleate Tablets, USP, 0.2 mg, 20 TABLETS (2 x 10), Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, in 46268, NDC 0904-7282-10. Blister Label: Methylergonovine Maleate Tablets, 0.2 mg, USP, One Tablet, Major Pharm/Indianapolis, IN 46268, NDC 0904-7282-10.

by The Harvard Drug Group LLC

Reason
Subpotent Drug
Recall initiated
June 16, 2026
Reported by FDA
July 1, 2026
Distribution
U.S. Nationwide.

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Drug Recall Ongoing 2026 recordClass II

Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc 400 units, Neomycin Sulfate 5 mg, Polymyxin B 5000 units, 1oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30255 8.

by Dabur India Limited

Reason
CGMP Deviations; deficiencies observed during FDA inspection
Recall initiated
June 2, 2026
Reported by FDA
June 24, 2026
Distribution
US Nationwide.

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Drug Recall Ongoing 2026 recordClass II

Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc (equivalent to 400 units), Neomycin Sulfate 5 mg, Polymixin B 5000 units, 0.9g packets, 144 packets per box, 130g, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 1 03 52410 30253 1.

by Dabur India Limited

Reason
CGMP Deviations; deficiencies observed during FDA inspection
Recall initiated
June 2, 2026
Reported by FDA
June 24, 2026
Distribution
US Nationwide.

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Drug Recall Ongoing 2026 recordClass II

Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 1 oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30503 0.

by Dabur India Limited

Reason
CGMP Deviations; deficiencies observed during FDA inspection
Recall initiated
June 2, 2026
Reported by FDA
June 24, 2026
Distribution
US Nationwide.

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Drug Recall Ongoing 2026 recordClass II

Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 16oz (454g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 305061.

by Dabur India Limited

Reason
CGMP Deviations; deficiencies observed during FDA inspection
Recall initiated
June 2, 2026
Reported by FDA
June 24, 2026
Distribution
US Nationwide.

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Drug Recall Ongoing 2026 recordClass II

Med Pride, 1% Clotrimazole Antifungal Cream, Net Wt. 1oz (28.3g), Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 524103 0244 2.

by Dabur India Limited

Reason
CGMP Deviations; deficiencies observed during FDA inspection
Recall initiated
June 2, 2026
Reported by FDA
June 24, 2026
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass II

Med Pride, Bacitracin Zinc Ointment, 1oz (28.3g) per tube, 72 tubes per case, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC X004WB4LKT.

by Dabur India Limited

Reason
CGMP Deviations; deficiencies observed during FDA inspection
Recall initiated
June 2, 2026
Reported by FDA
June 24, 2026
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass II

Med Pride, Bacitracin Zinc Ointment, 500 units, 1oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30354 8.

by Dabur India Limited

Reason
CGMP Deviations; deficiencies observed during FDA inspection
Recall initiated
June 2, 2026
Reported by FDA
June 24, 2026
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass II

Med Pride, Bacitracin Zinc Ointment, 500 units, 0.9g packets Net Wt 130g, 144 count box, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30352 4.

by Dabur India Limited

Reason
CGMP Deviations; deficiencies observed during FDA inspection
Recall initiated
June 2, 2026
Reported by FDA
June 24, 2026
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass II

Cura Hongos, Crema Antifungica, Clotrimazole 1%, 2oz (57g) tubes, Dist by/por: Pharmadel LLC, New Castle, DE 19720, Made in India, UPC 8 52924 00683 1.

by Dabur India Limited

Reason
CGMP Deviations; deficiencies observed during FDA inspection
Recall initiated
June 2, 2026
Reported by FDA
June 24, 2026
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass II

Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc 400 units, Neomycin Sulfate 3.5 mg, Polymyxin-B Sulfate 5,000 units, net wt. 2oz (57g) tubes, Distributed by/por: Pharmadel LLC, New Castle, DE 19720, Made in India, UPC 8 10096 77162 9.

by Dabur India Limited

Reason
CGMP Deviations; deficiencies observed during FDA inspection
Recall initiated
June 2, 2026
Reported by FDA
June 24, 2026
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass II

Lil Drug Store, Triple Antibiotic Ointment, Bacitracin Zinc (400 units), Neomycin Sulfate (3.5 mg), Polymyxin-B Sulfate (5000 units), net wt. 0.5 oz (14.2g), Product distributed by: Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404, Made in India, UPC 3 66715 97310 8.

by Dabur India Limited

Reason
CGMP Deviations; deficiencies observed during FDA inspection
Recall initiated
June 2, 2026
Reported by FDA
June 24, 2026
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass II

Circle K, triple antibiotic ointment, Bacitracin Zinc (400 units), Neomycin Sulfate (3.5 mg), Polymyxin-B Sulfate (5000 units), net wt. 0.5 oz (14.2g) tubes, Product manufactured for Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404, Made in India, UPC 1 94283 65181 0.

by Dabur India Limited

Reason
CGMP Deviations; deficiencies observed during FDA inspection
Recall initiated
June 2, 2026
Reported by FDA
June 24, 2026
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass II

Lucky Super Soft, First Aid Triple Antibiotic Ointment, Bacitracin zinc 400 units, neomycin sulphate 3.5 mg, polymyxin B sulphate 5000 units, Net Wt. 0.5 oz (14g) tubes, Manufactured for Delta Brands Inc., 580 White Plains Rd., Tarrytown, NY 10591 USA, Made in India, UPC 8 08829 10372 4.

by Dabur India Limited

Reason
CGMP Deviations; deficiencies observed during FDA inspection
Recall initiated
June 2, 2026
Reported by FDA
June 24, 2026
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass II

Lucky Super Soft, Antifungal Athlete's Foot Cream, Clotrimazole 1% Cream, Net Wt. 1.5 oz (42.5g) Tubes, Manufactured for Delta Brands Inc., 580 White Plains Rd., Tarrytown, NY 10591 USA, Made in India, UPC 8 08829 10461 5.

by Dabur India Limited

Reason
CGMP Deviations; deficiencies observed during FDA inspection
Recall initiated
June 2, 2026
Reported by FDA
June 24, 2026
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass II

Chlorthalidone Tablets, USP, 25 mg, [100 or 1000] Tablets pr bottle, Rx only, Manufactured by: Inventia Healthcare Limited, Additional Ambernath, M.I.D.C., Ambernath (East) - 421506, INDIA. Distributed by: Risiong Pharma Holdings, Inc., East Brunswick, NJ 08816. NDC 100-tablet bottle: 64980-599-01; NDC 1000-tablet bottle: 64980-599-10

by Inventia Healthcare Limited

Reason
Failed Dissolution Specifications
Recall initiated
June 5, 2026
Reported by FDA
June 24, 2026
Distribution
U.S. Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass III

Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manufactured by Societal CDMO Gainesville, LLC, Gainesville, GA 30504. NDC: 66758-235-31

by Sandoz Inc

Reason
Labeling: Incorrect or Missing Lot and/or Exp Date
Recall initiated
June 1, 2026
Reported by FDA
June 24, 2026
Distribution
U.S. 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.