CLASS II ONGOING Drug recall · Reported 3 Dec 2025 · FDA Enforcement Report
Karina Daily Moisturizer SPF 25, Octinoxate 7.5% and Zinc Oxide recalled
CA Botana International is recalling Karina Daily Moisturizer SPF 25, Octinoxate 7.5% and Zinc Oxide 7.0%, distributed in California, Colorado, Florida, Puerto Rico, Washington. The recall was initiated on 10 Oct 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0191-2026
- FDA event ID
- 97820
- Recalling firm
- CA Botana International, San Diego, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 Oct 2025
- FDA classified
- 26 Nov 2025
- Reported
- 3 Dec 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Sunscreen & Personal Care
Timeline
| 10 Oct 2025 | Recall initiated by company | |
| 26 Nov 2025 | Classified by FDA | +47 days |
| 3 Dec 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations
Product as listed by the FDA
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
Where it was distributed
CA, CO, FL, PR, WA
Questions about this recall
Why was it recalled?
CGMP Deviations
Which lots are affected?
Lot D54098, exp 3/31/2027
Where was it sold?
CA, CO, FL, PR, WA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.