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Public Health Trace collects, organizes, connects, and explains official recall, outbreak, surveillance, travel-health, and air-quality records from CDC, FDA, USDA, WHO, EPA, and other public sources. It also publishes original educational guides to help readers understand these records. Every imported record remains attributed and linked to its official source. It is an independent information service, not a medical provider, and not a substitute for professional medical advice or your local public health department's own guidance.

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Policy version 2026-07-21, effective July 21, 2026.

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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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Drug Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical Inc., Berkeley Heights, NJ 07922 NDC 51991-748-10.

by Breckenridge Pharmaceutical, Inc.

Reason: CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Recall initiated: November 24, 2025
Reported by FDA: December 10, 2025
Distribution: Nationwide within the United States

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Drug Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Manufactured for : Quallient Pharmaceuticals Health, LLC, Grand Cayman, Cayman Islands, NDC 82009-032-10.

by Breckenridge Pharmaceutical, Inc.

Reason: CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Recall initiated: November 24, 2025
Reported by FDA: December 10, 2025
Distribution: Nationwide within the United States

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Drug Recall Ongoing Historical recordClass II

Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, Sterile, Rx only, For Intramuscular Use Only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26605. NDC: 67457-426-12 with Safecor Health LLC KITCHECK RFID Tag attached with incorrect serial numbers: KITCHECK 8001-03A3,00000000,003A-2560, and 8001-03A3,00000000,003A-2D3B.

by Safecor Health, LLC

Reason: Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.
Recall initiated: October 10, 2025
Reported by FDA: December 10, 2025
Distribution: Distributed in Massachusetts

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Drug Recall Ongoing Historical recordClass II

Wecare Calasoothe, Net wt. 4 oz (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, NDC 67777-234-04.

by Blossom Pharmaceuticals

Reason: cGMP deviations
Recall initiated: October 31, 2025
Reported by FDA: December 10, 2025
Distribution: USA Nationwide

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Drug Recall Ongoing Historical recordClass II

Globe Zinc Oxide Ointment USP Zinc Oxide 20% Skin Protectant, Net Wt. 2 oz (56.7 g), Distributed by: Trifecta Pharmaceuticals USA 101 NE, Third Avenue, Suite 1500, Ft. Lauderdale, FL 33301, NDC 69396-086-02.

by Blossom Pharmaceuticals

Reason: cGMP deviations
Recall initiated: October 31, 2025
Reported by FDA: December 10, 2025
Distribution: USA Nationwide

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Drug Recall Ongoing Historical recordClass II

Globe Clotrimazole Cream USP, 1 % Antifungal Cream, Net Wt., 5 oz. (142 g, Distributed by: Trifecta Pharmaceuticals USA, 101 NE Third Avenue, Suite 1500, Ft. Lauderdale, FL 33301, USA, NDC 69396-087-55.

by Blossom Pharmaceuticals

Reason: cGMP deviations
Recall initiated: October 31, 2025
Reported by FDA: December 10, 2025
Distribution: USA Nationwide

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Drug Recall Ongoing Historical recordClass II

Globe Clotrimazole Cream, USP, 1 %, Net Wt. 1 oz (28.4g), Distributed by: Trifecta Pharmaceuticals USA, 101 NE Third Avenue, Suite 1500, Ft. Lauderdale, FL 33301 USA, Made in India, NDC 69396-087-01.

by Blossom Pharmaceuticals

Reason: cGMP deviations
Recall initiated: October 31, 2025
Reported by FDA: December 10, 2025
Distribution: USA Nationwide

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Drug Recall Ongoing Historical recordClass II

Nivagen, Zinc Oxide Ointment USP, Zinc Oxide 20 %, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA, Made in India, NDC 75834-170-02.

by Blossom Pharmaceuticals

Reason: cGMP deviations
Recall initiated: October 31, 2025
Reported by FDA: December 10, 2025
Distribution: USA Nationwide

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Drug Recall Ongoing Historical recordClass II

Nivagen, Zinc Oxide Ointment, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA Made in India, NDC 75834-170-01.

by Blossom Pharmaceuticals

Reason: cGMP deviations
Recall initiated: October 31, 2025
Reported by FDA: December 10, 2025
Distribution: USA Nationwide

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Drug Recall Ongoing Historical recordClass II

Dynashield, 4 oz cream (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10852, USA, Made in India, NDC 67777-407-03.

by Blossom Pharmaceuticals

Reason: cGMP deviations
Recall initiated: October 31, 2025
Reported by FDA: December 10, 2025
Distribution: USA Nationwide

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Drug Recall Ongoing Historical recordClass II

Nivagen Pharmaceuticals, Zinc Oxide Ointment USP, Zinc Oxide 20% Skin Protectant, Net Wt. 15 oz (425g), Made in India, Manufactured for: Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA, NDC 75834-170-15.

by Blossom Pharmaceuticals

Reason: cGMP deviations
Recall initiated: October 31, 2025
Reported by FDA: December 10, 2025
Distribution: USA Nationwide

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Drug Recall Ongoing Historical recordClass II

WeCare, Zinc Oxide Ointment, Net Wt. 15 oz/425 g, Manuactured for: Dynarex Corporation, 11 Dynarex Drive, Middletown, NY 10941, Made in India, NDC 67777-223-05.

by Blossom Pharmaceuticals

Reason: cGMP deviations
Recall initiated: October 31, 2025
Reported by FDA: December 10, 2025
Distribution: USA Nationwide

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Drug Recall Ongoing Historical recordClass II

Dynagel, Moisturizing Wound Hydrogel, Net Wt. 3oz (84.7 g), Manufactured for: Dynarex Corporation, 16 Glenshaw Street, Orangeburg, NY 10962, UPC 61784128016.

by Blossom Pharmaceuticals

Reason: cGMP deviations
Recall initiated: October 31, 2025
Reported by FDA: December 10, 2025
Distribution: USA Nationwide

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Drug Recall Ongoing Historical recordClass II

Wecare Enema, 4.5 Fl Oz/133mL, Manufactured for: Dynarex Corporation, 11 Dynarex Corporation, MIddletown, NY 10941 USA, Made in India, NDC 67777-402-01.

by Blossom Pharmaceuticals

Reason: cGMP deviations
Recall initiated: October 31, 2025
Reported by FDA: December 10, 2025
Distribution: USA Nationwide

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Drug Recall Ongoing Historical recordClass II

Dynashield Skin Protectant, Net Wt. 16 oz (453.6 g), Manufactured for: Dyrnarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, USA, Made in India, NDC 67777-407-04.

by Blossom Pharmaceuticals

Reason: cGMP deviations
Recall initiated: October 31, 2025
Reported by FDA: December 10, 2025
Distribution: USA Nationwide

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Drug Recall Ongoing Historical recordClass II

Lanashield Skin Barrier, 4 oz. (113 g), Manfuactured for: Dynarex Corporation, 10 Gleshaw Street, Orangeburg, NY 10962 USA, Made in India, UPC 616784126319.

by Blossom Pharmaceuticals

Reason: cGMP deviations
Recall initiated: October 31, 2025
Reported by FDA: December 10, 2025
Distribution: USA Nationwide

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Drug Recall Ongoing Historical recordClass II

Phenylephrine HCI, 1000 mcg / 10 mL, 10 mL Total Volume, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO, 63110-2512, NDC 83863-0104-1.

by Park Avenue Compounding

Reason: CGMP Deviations
Recall initiated: September 17, 2025
Reported by FDA: December 10, 2025
Distribution: MO

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Drug Recall Ongoing Historical recordClass III

Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-878-30; (b) 100-count bottle, NDC-68462-878-01; (c) 500-count bottles, NDC-68462-878-05; Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, Inda. Manufactured for: Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430.

by Glenmark Pharmaceuticals Inc., USA

Reason: Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
Recall initiated: November 21, 2025
Reported by FDA: December 10, 2025
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass III

Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: Actavis Laboratories, Inc, Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-3216-30. Packet label: Testosterone Gel 1%, contains 2.5 grams, For topical use only, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054,NDC: 0591-3216-17.

by Teva Pharmaceuticals USA, Inc

Reason: Defective Container - A defect in the side-seal which allows leakage of product.
Recall initiated: November 7, 2025
Reported by FDA: December 10, 2025
Distribution: U.S. Nationwide

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Drug Recall Ongoing Historical recordClass II

Phytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carton, Rx Only, Mfd. by: Cipla Ltd. India At M/s Immacule Lifesciences PVT. Ltd. India. Mfd. for: Cipla USA, Inc. Warren, NJ 07059. Vial NDC# 69097-708-31; Carton NDC 69097-708-96

by Cipla Limited

Reason: Failed Stability Specifications: Observed OOS results: eg results for colour index
Recall initiated: October 31, 2025
Reported by FDA: December 10, 2025
Distribution: Nationwide in the USA

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Data last updated: October 30, 2026 ET

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.