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 is a topical ointment containing menthol and zinc oxide. Consumers typically use it for soothing skin irritations and minor wounds.
The cGMP deviations may affect the product's quality and safety, potentially leading to ineffective treatment or adverse reactions.
This recall is not part of a broader industry pattern.
Consumers may face safety risks by using this product. Immediate action is necessary to prevent potential health issues.
Lot numbers can typically be found on the bottom or side of the container.
Expect processing for refunds or replacements to take approximately 4-6 weeks.
Keep copies of receipts, photographs of the product, and any communications with the manufacturer.
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.
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