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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 281–300 of 18,047 drug recalls

Drug Recall Ongoing 2026 recordClass II

BD ChloraPrep FREPP Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-30.

by CareFusion 213, LLC

Reason
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Recall initiated
May 28, 2026
Reported by FDA
July 1, 2026
Distribution
Nationwide inthe USA, as well as other foreign distribution.

View recall →

Drug Recall Ongoing 2026 recordClass II

BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1 mL Applicator, 60 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-31.

by CareFusion 213, LLC

Reason
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Recall initiated
May 28, 2026
Reported by FDA
July 1, 2026
Distribution
Nationwide inthe USA, as well as other foreign distribution.

View recall →

Drug Recall Ongoing 2026 recordClass II

PReye Vitamin See Antioxidant Preservative Free Eye Drops, Distributed by: PReye, LLC, Golden, CO

by PReye LLC

Reason
Lack of Assurance of Sterility
Recall initiated
May 18, 2026
Reported by FDA
July 1, 2026
Distribution
CO

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Drug Recall Ongoing 2026 recordClass III

hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC: 70954-912-10

by ANI Pharmaceuticals, Inc.

Reason
Presence of foreign substance
Recall initiated
June 2, 2026
Reported by FDA
July 1, 2026
Distribution
Nationwide in the USA

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Drug Recall Ongoing 2026 recordClass II

Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient specific), Rx# 24-1269856-0-1Compound Volume 1295 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharmacy Services, Boston, 55 6th Rd Woburn, Massachusetts 01801-1767.

by Central Admixture Pharmacy Services, Inc.

Reason
Incorrect product formulation: bag did not contain copper and famotidine per label.
Recall initiated
June 2, 2026
Reported by FDA
July 1, 2026
Distribution
MA

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Drug Recall Ongoing 2026 recordClass II

DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA, Packaged and Distributed by Direct Rx.

by Direct Rx

Reason
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Recall initiated
June 22, 2026
Reported by FDA
July 1, 2026
Distribution
U.S. Nationwide

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Drug Recall Ongoing 2026 recordClass II

Sensipar (cinacalcet) Tablets, 90mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks, CA 91320-1799, Made in Japan. NDC 55513-075-30

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, 7.5mg, 60-count bottles, Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy. NDC 55513-810-60

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

Sensipar (cinacalcet) Tablets, 60mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799, Made in Japan. NDC 55513-074-30

by Amgen, Inc.

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

View recall →

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

View recall →

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

View recall →

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.

View recall →

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.

View recall →

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.

View recall →

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.

View recall →

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 →

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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