Zinc Oxide Ointment Recalled Due to Manufacturing Practice Deviations
Blossom Pharmaceuticals is recalling Zinc Oxide Ointment nationwide due to Current Good Manufacturing Practice (cGMP) deviations at its production facility. The recall affects 2,592 bottles distributed across the USA.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for cGMP deviations with no documented illnesses or injuries cited in the source. The hazard is theoretical, placing this at High severity per the rubric.
Plain-English summary
Blossom Pharmaceuticals is recalling Zinc Oxide Ointment (brand WeCare) distributed nationwide in the United States. The topical ointment is supplied in 15 oz/425 g bottles, manufactured for Dynarex Corporation at a facility in Goa, India. The recall affects 2,592 bottles with lot numbers A062434 (expiration 6/27) and A062449 (expiration 7/27).
The recall was initiated due to Current Good Manufacturing Practice (cGMP) deviations—failures to comply with FDA manufacturing standards. Blossom Pharmaceuticals voluntarily initiated this recall on October 31, 2025. The recall is classified as FDA Class II, indicating a potential health hazard situation where product use may cause adverse health consequences.
Consumers who have purchased this product should stop using it and properly dispose of affected bottles. The recall is ongoing as of the most recent update. Anyone with concerns about exposure should contact a healthcare provider.
The recalled product
- Product
- ZINC OXIDE (ZINC OXIDE OINTMENT)
- Brand
- ZINC OXIDE
- Manufacturer
- Blossom Pharmaceuticals
- Category
- Drug — Topical OTC
- Hazard
- cgmp-deviation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #: A062434
- Exp. Date 6/27 & A062449
- Exp. Date 7/27
UPCs (3)
- 0616784119113
- 0616784119014
- 0616784119212
Distribution
Distributed nationwide across the United States.
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