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Public Health Trace republishes official recall, outbreak, and surveillance data from CDC, FDA, USDA, WHO, and other public sources. 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

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

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Drug Recall Ongoing Historical recordClass II

Sea Enzyme Ultra Umbrella Sunscreen SPF 30, Titanium Dioxide 4%, Octinoxate 4%, 4 oz./113.4 g per tube, Manufactured by CA BOTANA, San Diego, CA 92121. NDC: 35192-011-02

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 Controlling Cream, Benzoyl Peroxide 2.7%, 1 FL OZ/ 30 ML per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92123. NDC: 35192-017-05

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 Controlling Balm with Tea Tree Oil, Salicyclic Acid 0.8%, 1 FL OZ/ 30 ML per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92123. NDC: 35192-016-05

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 Flawless Skin Fluid Tinted Moisturizer SPF 50, Zinc Oxide 21%, 2.1 oz/61 g per tube, Manufactured by CA BOTANA, San Diego, CA 92121. NDC: 35192-043-17

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

Doctor. D. Schwab Mineral Sunscreen SPF 50, Zinc Oxide 21%, 4 oz./ 113.4 g per tube, Manufactured by CA Botana, San Diego, CA 92123. NDC: 35192-042-02

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 I

Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC 63323-739-11 (unit of use), 63323-739-12 (unit of sale).

by Fresenius Kabi USA, LLC

Reason: Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Recall initiated: November 6, 2025
Reported by FDA: December 3, 2025
Distribution: Nationwide within the United States as well as AK, HI, and PR.

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Drug Recall Ongoing Historical recordClass II

Walgreens Saline Nasal Spray WITH XYLITOL, 1.5 oz (45mL) bottle, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 60015, NDC 0363-3114-01

by Medical Products Laboratories, Inc.

Reason: Microbial contamination of a non-sterile product - microorganism found to be pseudomonas lactis
Recall initiated: November 12, 2025
Reported by FDA: December 3, 2025
Distribution: Nationwide USA

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Drug Recall Ongoing Historical recordClass I

POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL Flexible Container, Highly concentrated 100 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7074-26

by Otsuka ICU Medical LLC

Reason: Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq
Recall initiated: October 29, 2025
Reported by FDA: November 26, 2025
Distribution: US Nationwide.

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Drug Recall Ongoing Historical recordClass I

POTASSIUM CHLORIDE Inj., 20 mEq total in 50 mL Flexible Container, Highly concentrated 400 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7077-14

by Otsuka ICU Medical LLC

Reason: Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq
Recall initiated: October 29, 2025
Reported by FDA: November 26, 2025
Distribution: US Nationwide.

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Drug Recall Ongoing Historical recordClass II

Fentanyl citrate, 2 mcg / ml / Ropivacaine, 0.2% in NS 150 mL, CII, 150 mL bag, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO, 63110, NDC 83863-4272-1.

by Park Avenue Compounding

Reason: CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.
Recall initiated: September 23, 2025
Reported by FDA: November 26, 2025
Distribution: Distributed in Missouri

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Drug Recall Ongoing Historical recordClass II

UltraSure Anti-Perspirant & Deodorant, Aluminum Sesquichlorohydrate 15%, 118 mL (4 fl. oz.), DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-266-04

by DermaRite Industries, LLC

Reason: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Recall initiated: August 27, 2025
Reported by FDA: November 26, 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.