Mineral Sunscreen Recalled for Manufacturing Process Deviations
CA BOTANA's Doctor. D. Schwab Mineral Sunscreen SPF 50 is being recalled due to manufacturing process deviations. The recall affects 1,167 tubes distributed in CA, CO, FL, PR, and WA.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries and voluntary firm initiation. CGMP deviations without specified hazard constitute a precautionary manufacturing compliance recall.
Plain-English summary
Doctor. D. Schwab Mineral Sunscreen SPF 50, containing 21% zinc oxide, is being recalled by its manufacturer, CA BOTANA International, Inc. The recall affects 1,167 tubes of the 4 oz. (113.4g) size with Lot Code D54596, expiring January 31, 2028. The FDA assigned this recall number D-0183-2026.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations identified during the manufacturing process. This is a voluntary recall, initiated by the manufacturer itself on October 10, 2025, following FDA center classification on November 26, 2025.
The affected product was distributed to consumers in California, Colorado, Florida, Puerto Rico, and Washington. No illnesses or injuries related to this product have been reported.
The recalled product
- Product
- 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
- Manufacturer
- CA BOTANA International, Inc.
- Category
- Drug — Topical Sunscreen
- Hazard
- manufacturing-deviation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot Code D54596
- exp 1/31/2028
Distribution
Distributed in 5 states:
- CA
- CO
- FL
- PR
- WA
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