Unrated Drug recall · FDA · Published August 7, 2026

Bionpharma recalls Doxylamine-Pyridoxine tablets with foreign tablets risk

Bionpharma recalls 100-count Doxylamine Succinate and Pyridoxine HCl tablets (Rx only) made in India due to foreign tablets present. Consumers should contact the company for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0822-2026Drug Bionpharma ›

Recall notice

Presence of Foreign Tablets/Capsules

✎ GovInfoNow plain-language explainer

Bionpharma is recalling 100-count Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets (10 mg/10 mg) made in India because foreign tablets may be present. This could cause harm if taken without knowing the contents. Read more at govinfonow.com/recall/838290-bionpharma-recalls-doxylamine-pyridoxine-tablets-with-foreign-tablets-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/838290-bionpharma-recalls-doxylamine-pyridoxine-tablets-with-foreign-tablets-risk · Updated September 16, 2026 · FDA enforcement record: FDA #D-0822-2026

Cite this page

“Bionpharma recalls Doxylamine-Pyridoxine tablets with foreign tablets risk.” GovInfoNow, updated September 16, 2026. https://govinfonow.com/recall/838290-bionpharma-recalls-doxylamine-pyridoxine-tablets-with-foreign-tablets-risk. Based on FDA recall #D-0822-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0822-2026%22&limit=1).

Bionpharma Inc. recalled Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets due to the presence of foreign tablets or capsules, according to the FDA on Aug. 7, 2026.

How to tell if you have it

Brand: Bionpharma
Product: Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg
Packaging: 100-count bottle, Rx Only, MADE IN INDIA
NDC: 69452-206-20
Lot #: DMA25006
Expiration Date: 11/30/2028
Quantity: 14,232 bottles (1,423,200 tablets)
Distribution: US Nationwide

The hazard

The recall addresses the presence of foreign tablets or capsules within the product. The FDA classified this as a Class III recall.

Context

GovInfoNow's records show Bionpharma Inc. has had three other recalls since July 16, 2019. On June 26, 2026, the company recalled Divalproex Tablets due to a foreign tablets risk. Other recent recalls of similar products include Amgen's Corlanor recall on June 4, 2026, and Golden State's Baclofen recall on Nov. 26, 2025.

How to tell if you have this one

Check for the 100-count bottle labeled 'Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg' made in India. The product was distributed by Bionpharma Inc. in Princeton, NJ with NDC 69452-206-20 and lot number DMA25006.

Brand
Bionpharma
Category
Drug

Based on the official FDA remedy

What to do — step by step

Contact Bionpharma
Reach out to Bionpharma Inc. at their address in Princeton, NJ for specific instructions on handling the recalled product.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 33 days after the firm started it.

Aug 7, 2026Firm started the recall
Aug 28, 2026FDA classified it Class III
Sep 9, 2026Published in FDA’s Enforcement Report
Sep 15, 2026Added to GovInfoNow

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/838290-bionpharma-recalls-doxylamine-pyridoxine-tablets-with-foreign-tablets-risk">Bionpharma recalls Doxylamine-Pyridoxine tablets with foreign tablets risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0822-2026 (August 7, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0822-2026 to see it in context.
Plain-language summary written by qwen3:4b on September 16, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.