Doctor. D. Schwab Mineral Sunscreen SPF 50, Zinc Oxide 21%, 4 oz./ 113.4 g per tube, Manufactured by CA Botana, San Dieg
Summary
The FDA issued a Class II for Doctor. D. Schwab Mineral Sunscreen SPF 50, Zinc Oxide 21%, 4 oz./ 113.4 g per t by CA BOTANA International, Inc.. Reason: CGMP Deviations.
Details
Source
Drug Recall
External ID
D-0183-2026
Action Date
2025-12-03
Status
Ongoing
Category
drug
Product Description
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
Lot/Code Info: Lot Code D54596, exp 1/31/2028
Quantity Affected: 1167 tubes
Reason for Recall
CGMP Deviations
Distribution
CA, CO, FL, PR, WA
Type: Voluntary: Firm initiated
Recall Initiated: 2025-10-10
Company
San Diego, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 47 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
CA BOTANA International, Inc. has 14 FDA actions in our database, including 14 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (CA BOTANA International, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does CA BOTANA International, Inc. have FDA actions?
CA BOTANA International, Inc. has 14 FDA actions in our database, including 14 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0183-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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