FDA recall, , Low risk
Bionpharma Doxylamine Succinate and Pyridoxine HCl Delayed-Release Tablets 10 mg/10 mg
Doxylamine Succinate and Pyridoxine HCl tablets may contain foreign tablets or capsules.
Summary by Recall Canary from the FDA notice
What happened
Bionpharma Inc., of Princeton, New Jersey, recalled Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg, 100-count bottle, due to the presence of foreign tablets or capsules. The recall began August 7, 2026, and was added to the FDA's Enforcement Report on August 28, 2026. The product was distributed nationwide in the US.
The recalled tablets, made in India and distributed by Bionpharma Inc., are in a 100-count bottle. The recall involves 14,232 bottles, totaling 1,423,200 tablets.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg
- NDC
- 69452-206-20
- Lot code
- DMA25006
Recall details
- Company began the recall
- Sold in
US Nationwide.
- Company
- Bionpharma Inc.Princeton, New Jersey
- Hazard
- Foreign object
- Risk
Low risk
Taking it is unlikely to cause health problems.
FDA Class III recall · How risk is rated
- Event ID
- 99551
- Recall number
- D-0822-2026
- Quantity recalled
- 14,232 bottles (1,423,200 tablets)
All recalls from Bionpharma Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
