Why it was recalled
Presence of Foreign Tablets/Capsules
Product description
Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg, 100-count bottle, Rx Only, MADE IN INDIA, Distributed by: Bionpharma Inc., Princeton, NJ 08540 NDC 69452-206-20.
Lot numbers, UPCs & expiration codes
Lot # DMA25006, Exp Date: 11/30/2028.
Where it was sold
US 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-0822-2026
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Aug 7, 2026
- FDA report date
- Sep 9, 2026
- Quantity
- 14,232 bottles (1,423,200 tablets)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Bionpharma Inc.
Original FDA data
Every field from FDA enforcement report D-0822-2026, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 99551
- Address
- 400 Alexander Park Ste 2-4b
- Code information
- Lot # DMA25006, Exp Date: 11/30/2028.
- Postal code
- 08540-6539
- Report date
- Sep 9, 2026
- Product type
- Drugs
- Recall number
- D-0822-2026
- Classification
- Class III
- Recalling firm
- Bionpharma Inc.
- Product quantity
- 14,232 bottles (1,423,200 tablets)
- Reason for recall
- Presence of Foreign Tablets/Capsules
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg, 100-count bottle, Rx Only, MADE IN INDIA, Distributed by: Bionpharma Inc., Princeton, NJ 08540 NDC 69452-206-20.
- Distribution pattern
- US Nationwide.
- Recall initiation date
- Aug 7, 2026
- Initial firm notification
- Letter
- Center classification date
- Aug 28, 2026