Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg recall (Bionpharma Inc.)
DrugClass IIIOngoing
Summary: Bionpharma Inc. is recalling 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.
What is being recalled
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.
Why
Presence of Foreign Tablets/Capsules
How serious is it
Class III is the least serious level: using or being exposed to this product is not likely to cause health problems, but it breaks FDA rules.
Where it was sold
US Nationwide.
How to tell if yours is affected
Lot # DMA25006, Exp Date: 11/30/2028.
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0822-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class III |
| Status | Ongoing |
| Recall started | August 7, 2026 |
| Reported | September 9, 2026 |
| Company | Bionpharma Inc. |
| Company location | Princeton, NJ, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 14,232 bottles (1,423,200 tablets) |
More recalls from Bionpharma Inc. · all drug recalls · recalls from August 2026