OTC Topical Zinc Oxide Ointment Recalled for Manufacturing Process Deviations
Blossom Pharmaceuticals is recalling Globe Zinc Oxide 20% Ointment due to manufacturing process deviations. The voluntary recall affects 33,000 containers distributed nationwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II voluntary precautionary recall with no reported illnesses, injuries, or hospitalizations. The hazard consists of manufacturing process deviations without specified product contamination or identified harm, fitting the criterion for voluntary precautionary recalls.
Plain-English summary
Blossom Pharmaceuticals is voluntarily recalling Globe Zinc Oxide Ointment USP 20% Skin Protectant across the United States. The recall affects approximately 33,000 containers with the following lot numbers and expiration dates: Lot #A502404 (Exp. 2/27), Lot #A502405 (Exp. 2/27), and Lot #AS02502 (Exp. 2/28). The product is a topical OTC drug packaged in 2-ounce (56.7g) containers.
The recall was initiated due to Current Good Manufacturing Practice (cGMP) deviations in the manufacturing process. The firm initiated the recall voluntarily and notified the FDA by letter on October 31, 2025, with the FDA center classification completed on December 2, 2025.
Consumers who have this product should stop using it and consult a healthcare provider or poison control center for guidance on safe disposal. For replacement or refund information, consumers may contact Trifecta Pharmaceuticals USA at the address provided on the product packaging.
The recalled product
- Product
- ZINC OXIDE 20% (ZINC OXIDE)
- Brand
- ZINC OXIDE 20%
- Manufacturer
- Blossom Pharmaceuticals
- Category
- Drug — Topical OTC
- Hazard
- manufacturing-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 (5)
- Lot #: A502404
- Exp. Date 2/27
- A502405
- AS02502
- Exp. Date 2/28.
UPCs (1)
- 0040232454912
Distribution
Distributed nationwide across the United States.
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