CLASS II ONGOING Drug recall · Reported 5 Jun 2024 · FDA Enforcement Report
Bull Frog SPF 50 Amphibious Lotion SPF 50 Amphibious Lotion recalled
ARG Laboratories is recalling Bull Frog SPF 50 Amphibious Lotion SPF 50 Amphibious Lotion with Water Armor Tech, Broad, distributed nationwide in the US. The recall was initiated on 17 Apr 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0522-2024
- FDA event ID
- 94354
- Recalling firm
- ARG Laboratories, Dallas, TX
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Apr 2024
- FDA classified
- 30 May 2024
- Reported
- 5 Jun 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 17 Apr 2024 | Recall initiated by company | |
| 30 May 2024 | Classified by FDA | +43 days |
| 5 Jun 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Out of Specification for active ingredient
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Distributed Nationwide in the USA
Questions about this recall
Is Bull Frog SPF 50 Amphibious Lotion SPF 50 Amphibious Lotion with Water Armor Tech, Broad recalled?
Yes. ARG Laboratories recalled Bull Frog SPF 50 Amphibious Lotion SPF 50 Amphibious Lotion with Water Armor Tech, Broad on 17 Apr 2024. The recall is Class II and its status is Ongoing. Recall number D-0522-2024.
Why was it recalled?
Out of Specification for active ingredient
Which lots are affected?
Lot 08623C2, 08923C2, Exp 03/31/2026
Where was it sold?
Distributed Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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