Why it was recalled
cGMP deviations
Product description
Nivagen, Zinc Oxide Ointment USP, Zinc Oxide 20 %, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA, Made in India, NDC 75834-170-02.
Lot numbers, UPCs & expiration codes
Lot #: A352505
Where it was sold
USA Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0209-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Oct 31, 2025
- FDA report date
- Dec 10, 2025
- Quantity
- 7920 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Blossom Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-0209-2026, exactly as published.
Show all FDA fields
- City
- Bardej, Goa
- Status
- Ongoing
- Country
- India
- Event ID
- 97935
- Address
- Plot No. 21/22 Bardez Blossom Pharmaceuticals Karaswada-Tivim
- Code information
- Lot #: A352505
- Report date
- Dec 10, 2025
- Product type
- Drugs
- Recall number
- D-0209-2026
- Classification
- Class II
- Recalling firm
- Blossom Pharmaceuticals
- Product quantity
- 7920 bottles
- Reason for recall
- cGMP deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Nivagen, Zinc Oxide Ointment USP, Zinc Oxide 20 %, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA, Made in India, NDC 75834-170-02.
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Oct 31, 2025
- Initial firm notification
- Letter
- Center classification date
- Dec 2, 2025