Wound Care Hydrogel Dynagel Recalled for Manufacturing Deviations
Blossom Pharmaceuticals is recalling Dynagel Moisturizing Wound Hydrogel due to manufacturing process deviations. The recall affects 8,184 bottles distributed nationwide in the United States.
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: FDA Class II voluntary precautionary recall for manufacturing process deviations. No illnesses, injuries, or deaths have been reported. The recall is firm-initiated and precautionary, consistent with Moderate severity for manufacturing-quality issues without documented adverse health events.
Plain-English summary
Blossom Pharmaceuticals is recalling Dynagel Moisturizing Wound Hydrogel due to current Good Manufacturing Practice (cGMP) deviations identified during manufacturing. The affected product is packaged in 3-ounce (84.7-gram) bottles with UPC 61784128016.
The recall involves 8,184 bottles with lot numbers A322301 (expiration date 7/26) and A322302 (expiration date 8/26). The product has been distributed nationwide throughout the United States.
The FDA classified this as a Class II recall. This is a voluntary recall initiated by the manufacturer. Consumers who have purchased affected bottles should stop using the product immediately. Those with questions should contact Blossom Pharmaceuticals or consult their healthcare provider.
The recalled product
- Product
- Dynagel, Moisturizing Wound Hydrogel, Net Wt. 3oz (84.7 g), Manufactured for: Dynarex Corporation, 16 Glenshaw Street, Orangeburg, NY 10962, UPC 61784128016.
- Manufacturer
- Blossom Pharmaceuticals
- Category
- Drug — Wound Care / Hydrogel
- 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 (3)
- Lot #: A322301
- Exp. Date 7/26 & A322302
- Exp. Date 8/26
Distribution
Distributed nationwide across the United States.
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