FDA Recalls Dynashield Zinc Oxide Cream for Manufacturing Compliance Issues
Dynashield zinc oxide cream is being recalled due to Good Manufacturing Practice deviations. The recall affects 7,944 containers distributed nationwide in the USA.
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 recall with no reported illnesses or injuries. The cGMP deviations indicate manufacturing process compliance issues without specific confirmed hazards. The voluntary nature and lack of reported harm classify this as Moderate severity.
Plain-English summary
Dynashield, a 4-ounce zinc oxide cream manufactured by Blossom Pharmaceuticals for Dynarex Corporation, is being recalled due to Good Manufacturing Practice (cGMP) deviations. The recall affects 7,944 containers distributed nationwide across the United States.
Affected lots are A092421 (expiration date July 27), A092340 (expiration date October 26), and A092346 (expiration date November 26). The product is sold under NDC 67777-407-03.
The FDA classified this as a Class II recall and the manufacturer initiated the recall voluntarily. No illnesses or injuries have been reported in connection with this product.
Consumers who have purchased this product should discontinue use. Those with questions should contact their healthcare provider or pharmacist.
The recalled product
- Product
- DYNASHIELD (ZINC OXIDE)
- Brand
- DYNASHIELD
- Manufacturer
- Blossom Pharmaceuticals
- 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 (5)
- Lot #: A092421
- Exp. Date 7/27
- A092340
- Exp. Date 10/26 & A092346
- Exp. Date 11/26.
UPCs (3)
- 0616784119519
- 0840117346543
- 0616784119618
Distribution
Distributed nationwide across the United States.
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