D-0822-2026Class III

Bionpharma Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm

Bionpharma Inc.

Product type

Drug

Status

Ongoing

Report date

2026-09-09

Distribution

US Nationwide.

Firm state

Product quantity

14,232 bottles (1,423,200 tablets)

Initiated by

Voluntary: Firm initiated

Reason for recall

Presence of Foreign Tablets/Capsules

Product description

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.

Code / lot info

Lot # DMA25006, Exp Date: 11/30/2028.

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →