Wecare Calasoothe, Net Wt. 4 Oz (113 G), Manufactured For: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, Ny 10962, Ndc 67777-234-04.
Wecare Calasoothe 4 oz cream manufactured by Dynarex Corporation is being recalled nationwide due to manufacturing process deviations that don't meet FDA standards. The product was distributed across all U.S. states. This is a Class I recall, the most serious classification.
- Recalling firm
- Blossom Pharmaceuticals
- Product
- Wecare Calasoothe, Net wt. 4 oz (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, NDC 67777-234-04.
- Reason
- cGMP deviations
- Classification
- Class I
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2025-10-31
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- USA Nationwide
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/106166c7-02b8-4fe9-85c8-a58a87603a2a