Wound hydrogel recalled over current good manufacturing practice deviations
Blossom Pharmaceuticals is recalling 8,184 bottles of Dynagel Moisturizing Wound Hydrogel over current good manufacturing practice deviations.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: Scored 2 because the record cites current good manufacturing practice deviations with no stated product defect or reported harm.
Plain-English summary
Dynagel Moisturizing Wound Hydrogel, net weight 3 oz (84.7 g), is being recalled. The product is manufactured for Dynarex Corporation of 16 Glenshaw Street, Orangeburg, New York, and carries UPC 61784128016.
The reason given in the enforcement record is current good manufacturing practice deviations.
The recall covers 8,184 bottles from lots A322301, expiry 7/26, and A322302, expiry 8/26. Distribution was nationwide in the USA. The FDA has classified the action as Class II.
The record cites manufacturing practice deviations without describing a specific product defect, and states no injuries. Customers should follow the firm's instructions.
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
- Affected units
- 8,184
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.
Part of a larger recall action
This product is one of 13 recalled by Blossom Pharmaceuticals under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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