OTC drug moisturizer recalled due to manufacturing process deviations
Karina Daily Moisturizer SPF 25 is being recalled by CA BOTANA International due to Current Good Manufacturing Practice (CGMP) deviations. The voluntary recall affects 1,492 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: This is an FDA Class II recall for CGMP deviations, a manufacturing process issue. No illnesses, injuries, or specific safety hazards are reported in the source, making this a Moderate severity recall.
Plain-English summary
CA BOTANA International, Inc. is voluntarily recalling Karina Daily Moisturizer SPF 25 (Octinoxate 7.5% and Zinc Oxide 7.0%) due to Current Good Manufacturing Practice (CGMP) deviations. The product is a topical daily moisturizer with sunscreen protection, distributed in 5 oz (141.7 g) tubes.
The recall was initiated on October 10, 2025, following identification of manufacturing process deviations that do not meet FDA CGMP standards. The firm notified the FDA by letter and initiated a voluntary recall on December 3, 2025.
The affected product (Lot D54098, expiring March 31, 2027, NDC 35192-033-16) was distributed to CA, CO, FL, PR, and WA. A total of 1,492 tubes are involved in this recall.
Consumers who have purchased this product should stop using it. Consult a healthcare provider if you have questions about the safety of this product.
The recalled product
- Product
- 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
- Manufacturer
- CA BOTANA International, Inc.
- Category
- Drug — Topical / Sunscreen
- Hazard
- cgmp-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 D54098
- exp 3/31/2027
Distribution
Distributed in 5 states:
- CA
- CO
- FL
- PR
- WA
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