FDA Drug recall D-0213-2026
Wecare Calasoothe, Net wt. 4 oz (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, NDC 67777-234-04
- FDA Drug
- Class II
- ongoing
- Published 2025-12-10
On 2025-12-10 the FDA classified a Class II recall of Wecare Calasoothe, Net wt. 4 oz (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, NDC 67777-234-04 by Blossom Pharmaceuticals, citing cGMP deviations.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0213-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-10-31 |
| Published | 2025-12-10 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Blossom Pharmaceuticals |
| Distribution | US |
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
Identifiers
| ndc | 67777-234-02 |
|---|---|
| ndc | 67777-234-01 |
| ndc | 67777-234-04 |
| ndc | 67777-234-03 |
| code_info | Lot #: A482305 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0213-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.