FDA Recall D-0522-2024

ARG Laboratories, Inc. · Dallas, TX

Class II Ongoing 757 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

Bull Frog SPF 50 Amphibious Lotion SPF 50 Amphibious Lotion with Water Armor Tech, Broad Spectrum Sunscreen with UVA/UVB Protection, NEW WT. 5 FL OZ (148ML), Distributed by: Bullfrog Brands LLC, PO Box 600207, Dallas, TX 75360 USA. UPC 8 50016 52112 5

Lot / code: Lot 08623C2, 08923C2, Exp 03/31/2026

Quantity: 9,697

Reason for recall

Out of Specification for active ingredient

Recall record

Recall number: D-0522-2024
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Distributed Nationwide in the USA
Recall initiated: 2024-04-17
Classified by FDA Center: 2024-05-30
FDA published: 2024-06-05
Recalling firm: ARG Laboratories, Inc.
Firm location: Dallas, TX

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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