Bionpharma recall: Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg
Bionpharma Inc. is recalling Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg – 14,232 bottles (1,423,200 tablets). The U.S. Food and Drug Administration published the recall on September 9, 2026; it began on August 7, 2026. Distributed nationwide.
Lower risk Class III means using the product is not likely to cause health problems; it breaks a labeling or manufacturing rule.
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| Product | Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg |
| Brand | Bionpharma |
| Company | Bionpharma Inc. |
| Type | Drugs |
| Classification | Class III |
| Recall date | August 7, 2026 |
| Published by FDA | September 9, 2026 |
| Quantity | 14,232 bottles (1,423,200 tablets) |
| Recall ID | 99551 |
Recalled products
- 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 number
- D-0822-2026
- Codes, lots and dates
- Lot # DMA25006, Exp Date: 11/30/2028.
- Quantity
- 14,232 bottles (1,423,200 tablets)
- Classification
- Class III
Identifiers and details
- FDA event ID
- 99551
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Princeton, NJ, United States
Why it was recalled
The reason the FDA lists: “Presence of Foreign Tablets/Capsules”
Where it was sold
Nationwide. Distribution as the FDA records it: “US Nationwide.”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99551, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
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About this recall
Is Bionpharma Doxylamine Succinate recalled?
Yes. Bionpharma Inc. recalled it on August 7, 2026; FDA published it September 9, 2026 (Class III). Only the lots, dates or models listed on this page are included.
Why was it recalled?
Presence of Foreign Tablets/Capsules
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.