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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

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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Drug Recall Ongoing Historical recordClass II

Dr. Bump Natural Pain Relief Gel, Menthol 5%, NET WT 4 FL OZ/118 ML per bottle, Distr. by 1Beauty US LLC, Palm Desert, CA 92211. NDC: 35192-052-18, UPC 8 18204 02513 8

by CA BOTANA International, Inc.

Reason: CGMP Deviations
Recall initiated: October 10, 2025
Reported by FDA: December 3, 2025
Distribution: CA, CO, FL, PR, WA

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Drug Recall Ongoing Historical recordClass II

CLEARSTEM YOU ARE SUNSHINE SPF 50, Zinc Oxide 21%, 2.1 oz/61g per bottle, Distributed by: CLEARSTEM Skincare, clearstemskincare.com. NDC: 35192-046-17

by CA BOTANA International, Inc.

Reason: CGMP Deviations
Recall initiated: October 10, 2025
Reported by FDA: December 3, 2025
Distribution: CA, CO, FL, PR, WA

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Drug Recall Ongoing Historical recordClass II

Elixir by Coco March Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz (62g) per bottle, Distributed by: VitaTienda Co U.S.A., San Juan, PR 00646. NDC: 35192-050-17, UPC 6 7229 99913 8

by CA BOTANA International, Inc.

Reason: CGMP Deviations
Recall initiated: October 10, 2025
Reported by FDA: December 3, 2025
Distribution: CA, CO, FL, PR, WA

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Drug Recall Ongoing Historical recordClass II

Elixir by Coco March Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz (62g) per bottle, Distributed by: VitaTienda Co U.S.A., San Juan, PR 00646. NDC: 35192-048-17, UPC 8 10145 82007 0

by CA BOTANA International, Inc.

Reason: CGMP Deviations
Recall initiated: October 10, 2025
Reported by FDA: December 3, 2025
Distribution: CA, CO, FL, PR, WA

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Drug Recall Ongoing Historical recordClass II

Sugared+Bronzed Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, Net WT 3.3 OZ (93 G) per tube, Dist. By: Sugared+Bronzed, 929 Montana Ave, Santa Monica, CA 90403. NDC: 35192-055-18, UPC 8 50047 92223 6

by CA BOTANA International, Inc.

Reason: CGMP Deviations
Recall initiated: October 10, 2025
Reported by FDA: December 3, 2025
Distribution: CA, CO, FL, PR, WA

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Drug Recall Ongoing Historical recordClass II

Karina Daily Moisturizer SPF 25, Octinoxate 7.5% and Zinc Oxide 7.0%, Net WT. 5 oz/ 141.7 g per tube, Dist. By: Beauty4Pros LLC, Palm Desert, CA 92211. NDC: 35192-033-16, UPC 8 18204 02572 5

by CA BOTANA International, Inc.

Reason: CGMP Deviations
Recall initiated: October 10, 2025
Reported by FDA: December 3, 2025
Distribution: CA, CO, FL, PR, WA

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Drug Recall Ongoing Historical recordClass II

Gabriel Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz, Net 61 g per tube, Dist. By: Gabriel Cosmetics, Inc., Redmond, WA USA 98052, NDC: 35192-044-01, UPC 7 07060 9592 1

by CA BOTANA International, Inc.

Reason: CGMP Deviations
Recall initiated: October 10, 2025
Reported by FDA: December 3, 2025
Distribution: CA, CO, FL, PR, WA

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Drug Recall Ongoing Historical recordClass II

Doctor D. Schwab Shimmery Sun Lotion Sunscreen SPF 30, Titanium Dioxide 5% and Octinoxate 4%, 4 oz./113.4 g per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92121. NDC: 35192-012-02

by CA BOTANA International, Inc.

Reason: CGMP Deviations
Recall initiated: October 10, 2025
Reported by FDA: December 3, 2025
Distribution: CA, CO, FL, PR, WA

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Drug Recall Ongoing Historical recordClass II

Doctor D. Schwab Clinical Weh Weh Natural Pain Relief Gel with Menthol and Arnica, Menthol 5%, 4.2 oz./120 g per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92121. NDC: 35192-020-02

by CA BOTANA International, Inc.

Reason: CGMP Deviations
Recall initiated: October 10, 2025
Reported by FDA: December 3, 2025
Distribution: CA, CO, FL, PR, WA

View recall →

Data last updated: September 6, 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.