FDA Drug Recalls

Recalls / Class II

Class IID-0183-2026

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

Affected lot / code info
Lot Code D54596, exp 1/31/2028

Why it was recalled

CGMP Deviations

Recalling firm

Firm
CA BOTANA International, Inc.
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
9505 Chesapeake Dr, N/A, San Diego, California 92123-1304

Distribution

Quantity
1167 tubes
Distribution pattern
CA, CO, FL, PR, WA

Timeline

Recall initiated
2025-10-10
FDA classified
2025-11-26
Posted by FDA
2025-12-03
Status
Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0183-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.