Dynarex Corporation recalled 2,400 containers of Wecare Calasoothe on October 31, 2025, due to cGMP deviations. The recall affects the 4 oz ointment, as it may not meet safety standards. Consumers should stop using the product immediately and consult their healthcare providers.
cGMP deviations
Consumers and healthcare providers should stop using this product immediately. Contact Blossom Pharmaceuticals or your healthcare provider for guidance. Notification method: Letter
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Wecare Calasoothe has a net weight of 4 oz (113 g) and is manufactured by Dynarex Corporation, located at 10 Glenshaw Street, Orangeburg, NY 10962. The product is identified by NDC 67777-234-04 and was distributed nationwide in the USA.
The recall stems from deviations in current Good Manufacturing Practices (cGMP). Such violations can lead to compromised product quality and safety.
No specific incidents or injuries have been reported in connection with this recall. However, the potential for safety issues exists due to the cGMP deviations.
Consumers and healthcare providers should stop using Wecare Calasoothe immediately. Contact Blossom Pharmaceuticals or your healthcare provider for further guidance.
For more information, contact Blossom Pharmaceuticals directly or visit the FDA recall notice at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0213-2026.
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