Recalls / Class II
Class IID-0213-2026
Product
Wecare Calasoothe, Net wt. 4 oz (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, NDC 67777-234-04.
- Brand name
- Menthol And Zinc Oxide
- Generic name
- Menthol And Zinc Oxide
- Active ingredients
- Menthol, Zinc Oxide
- Route
- Topical
- NDC
- 67777-234
- FDA application
- M017
- Affected lot / code info
- Lot #: A482305
Why it was recalled
cGMP deviations
Recalling firm
- Firm
- Blossom Pharmaceuticals
- Manufacturer
- Dynarex Corporation
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Plot No. 21/22 Bardez Blossom Pharmaceuticals Karaswada-Tivim, Bardej, Goa, N/A, India
Distribution
- Quantity
- 2400 containers
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2025-10-31
- FDA classified
- 2025-12-02
- Posted by FDA
- 2025-12-10
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0213-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.