Class II · Moderate risk
Karina Daily Moisturizer SPF 25
CGMP Deviations
Sea Enzyme Ultra Umbrella Sunscreen SPF 30
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Sea Enzyme Ultra Umbrella Sunscreen SPF 30, Titanium Dioxide 4%, Octinoxate 4%, 4 oz./113.4 g per tube, Manufactured by CA BOTANA, San Diego, CA 92121. NDC: 35192-011-02
Affected NDC
35192-0011-02
Compare with the code on your package — it is the most precise check available.
Drug: Octinoxate
- Recalling firm
- CA BOTANA International, Inc.
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0187-2026 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
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Class II · Moderate risk
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CGMP Deviations
Class II · Moderate risk
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GMP Deviations
Class II · Moderate risk
Tropical Lip Moisturizer
Superpotent Drug: The beginning portion of the batch appears to be approximately 25% superpotent for active ingredient Meradimate.
Class II · Moderate risk
Rocky Mountain Sunscreen SPF30 Kiwi Flavored Lip Balm
Superpotent Drug: Active Ingredient Octisalate found at 15% above label claim.
Other recalls by CA BOTANA International, Inc.
All 2025 recalls
Class II · Moderate risk
Dr. Bump Natural Pain Relief Gel
CGMP Deviations
Class II · Moderate risk
Clearstem You Are Sunshine Spf 50
CGMP Deviations
Class II · Moderate risk
Elixir by Coco March Tinted Mineral Sunscreen SPF 50
CGMP Deviations
Class II · Moderate risk
Elixir by Coco March Mineral Sunscreen SPF 50
CGMP Deviations
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