FDA recalls Doctor D. Schwab sunscreen for manufacturing compliance deviations
CA BOTANA International is recalling 805 tubes of Doctor D. Schwab Shimmery Sun Lotion Sunscreen SPF 30 due to manufacturing compliance deviations. The affected product was distributed in California, Colorado, Florida, Puerto Rico, and Washington.
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: This is classified as FDA Class II with no reported illnesses, injuries, or hospitalizations. The recall is voluntary and firm-initiated; manufacturing compliance issues without reported harm align with a Moderate severity score per the rubric.
Plain-English summary
CA BOTANA International, Inc. is recalling 805 tubes of Doctor D. Schwab Shimmery Sun Lotion Sunscreen SPF 30 (Titanium Dioxide 5% and Octinoxate 4%, 4 oz./113.4 g per tube, NDC 35192-012-02) due to Current Good Manufacturing Practice (CGMP) deviations.
The recall was initiated by the manufacturer after identifying CGMP deviations at the manufacturing facility. These deviations indicate that manufacturing processes or controls did not meet FDA requirements.
The affected product was distributed to retailers in California, Colorado, Florida, Puerto Rico, and Washington. The recalled lot is Lot D54597 with an expiration date of January 31, 2028.
The recalled product
- Product
- 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
- Manufacturer
- CA BOTANA International, Inc.
- Category
- Drug — 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 D54597
- exp 1/31/2028
Distribution
Distributed in 5 states:
- CA
- CO
- FL
- PR
- WA
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