Class II · Moderate risk
Wecare Calasoothe
cGMP deviations
Dynashield Skin Protectant (Zinc Oxide)
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
Dynashield Skin Protectant, Net Wt. 16 oz (453.6 g), Manufactured for: Dyrnarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, USA, Made in India, NDC 67777-407-04.
Affected NDC
67777-0407-04
Compare with the code on your package — it is the most precise check available.
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 |
|---|---|---|---|---|
| Dynashield zinc oxide NDC 67777-0407 |
1.8 g/100g | Cream Topical |
Dynarex Corporation | OTC |
- Recalling firm
- Blossom Pharmaceuticals
- NDC code
- 67777-407-04
- Origin
- India
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0202-2026 · 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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