Class IIIDrug
Doxylamine Succinate and Pyridoxine HCl Delayed-Release… recall
Summary
Bionpharma Inc. is recalling Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg (drug). According to the FDA report, the reason is: Presence of Foreign Tablets/Capsules. The FDA rated this a Class III: the product is unlikely to cause health problems but violates fda rules (e.g. labeling). Recall status: Ongoing.
Details from the FDA report
- 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
- Presence of Foreign Tablets/Capsules
- Lot / code info
- Lot # DMA25006, Exp Date: 11/30/2028.
- Quantity
- 14,232 bottles (1,423,200 tablets)
- Distribution
- US Nationwide.
- Recalling company
- Bionpharma Inc., Princeton, NJ United States
- Recall started
- August 7, 2026
- FDA report date
- September 9, 2026
- Classification
- Class III: The product is unlikely to cause health problems but violates FDA rules (e.g. labeling).
- Voluntary / mandated
- Voluntary: Firm initiated
- Status
- Ongoing
- Recall number
- D-0822-2026
What to do
- Check whether you have this product, and compare the lot numbers, codes, or dates on your package with the codes listed above.
- If it matches, stop using it and keep it away from children and pets.
- Contact the recalling company (Bionpharma Inc.) or the store where you bought it about returns or refunds.
- Do not stop a prescribed medication without first talking to your pharmacist or doctor; they can help find a safe replacement.
- If you think the product made you or someone else sick, contact a doctor or pharmacist. In an emergency call 911.
- You can report problems to the FDA via MedWatch.