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CLASS II · ModerateFDA

Blossom Pharmaceuticals recalls Nivagen

📅 Oct 31, 2025 · 📍 Nationwide
Recalling company
Blossom Pharmaceuticals
Product
Nivagen, Zinc Oxide Ointment, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA Made in India, NDC 75834-170-01.
Reason
cGMP deviations
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Oct 31, 2025
Reported
Dec 10, 2025
Distribution
USA Nationwide
Status
Ongoing
Quantity
13536 containers
Lot / codes
Lot #: A352405
Company location
Bardej, Goa
Recall type
Voluntary: Firm initiated
Recall number
D-0208-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number D-0208-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.