Class II · Moderate risk
Zicam
CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
Globe Zinc Oxide Ointment USP Zinc Oxide 20% Skin Protectant
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
Globe Zinc Oxide Ointment USP Zinc Oxide 20% Skin Protectant, Net Wt. 2 oz (56.7 g), Distributed by: Trifecta Pharmaceuticals USA 101 NE, Third Avenue, Suite 1500, Ft. Lauderdale, FL 33301, NDC 69396-086-02.
Affected NDC
69396-0086-02
Compare with the code on your package — it is the most precise check available.
Drug: Zinc
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Zinc Oxide 20% Zinc Oxide NDC 69396-0086 |
.2 g/g | Ointment Topical |
Trifecta Pharmaceuticals USA | OTC |
- Recalling firm
- Blossom Pharmaceuticals
- NDC code
- 69396-086-02
- Origin
- India
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0212-2026 · 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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