Why it was recalled
cGMP deviations
Product description
Wecare Calasoothe, Net wt. 4 oz (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, NDC 67777-234-04.
Lot numbers, UPCs & expiration codes
Lot #: A482305
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-0213-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Oct 31, 2025
- FDA report date
- Dec 10, 2025
- Quantity
- 2400 containers
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Blossom Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-0213-2026, 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 #: A482305
- Report date
- Dec 10, 2025
- Product type
- Drugs
- Recall number
- D-0213-2026
- Classification
- Class II
- Recalling firm
- Blossom Pharmaceuticals
- Product quantity
- 2400 containers
- Reason for recall
- cGMP deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Wecare Calasoothe, Net wt. 4 oz (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, NDC 67777-234-04.
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Oct 31, 2025
- Initial firm notification
- Letter
- Center classification date
- Dec 2, 2025