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Drug FDA Class II Ongoing cGMP deviation

Lanashield Skin Barrier, 4 oz. (113 g), Manfuactured for: Dynarex Corporation, 10 Gleshaw Street, Orangeburg, NY 10962 USA, Made in India, UPC 616784126319.

Blossom Pharmaceuticals Published Dec 10, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Blossom Pharmaceuticals or your place of purchase with questions, and see the source record below for full details.
Reason for recall

cGMP deviations

Affected products (1)

Lanashield Skin Barrier, 4 oz. (113 g), Manfuactured for: Dynarex Corporation, 10 Gleshaw Street, Orangeburg, NY 10962 USA, Made in India, UPC 616784126319.

9600 containers

Code info: Lot #: A162301, Exp. Date 9/26; A162401, Exp. Date 4/27 & A162202, Exp. Date 11/25.

Affected areas

Nationwide

Timeline

  1. Initiated
    Oct 31, 2025
  2. Published
    Dec 10, 2025
Recall number
D-0201-2026
Agency
U.S. Food and Drug Administration
Country
US

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.