Dynashield, 4 oz cream (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10852, USA, Ma
Summary
The FDA issued a Class II for Dynashield, 4 oz cream (113 g), Manufactured for: Dynarex Corporation, 10 Glensh by Blossom Pharmaceuticals. Reason: cGMP deviations.
Details
Source
Drug Recall
External ID
D-0207-2026
Action Date
2025-12-10
Status
Ongoing
Category
drug
Product Description
Dynashield, 4 oz cream (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10852, USA, Made in India, NDC 67777-407-03.
Lot/Code Info: Lot #: A092421, Exp. Date 7/27, A092340, Exp. Date 10/26 & A092346, Exp. Date 11/26.
Quantity Affected: 7944 containers
Reason for Recall
cGMP deviations
Distribution
USA Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2025-10-31
Company
Bardej, Goa
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 51 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Blossom Pharmaceuticals has 13 FDA actions in our database, including 13 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Blossom Pharmaceuticals) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Blossom Pharmaceuticals have FDA actions?
Blossom Pharmaceuticals has 13 FDA actions in our database, including 13 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0207-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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