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.

FDA recall notice · announced September 9, 2026 · Bionpharma

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

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.

Reason for recall

Presence of Foreign Tablets/Capsules

Notes

Distribution: US Nationwide.
Lot/code information: Lot # DMA25006, Exp Date: 11/30/2028.
Quantity: 14,232 bottles (1,423,200 tablets)
Status: Ongoing
Products in this recall event:
- 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. (D-0822-2026)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.