August 2026 FDA Recall Doxylamine Succinate And Pyridoxine Hydrochloride by Bionpharma Inc.
D-0822-2026 - Presence of Foreign Tablets/Capsules

This Class III drug recall was voluntarily initiated by Bionpharma Inc. on August 7, 2026 for the product Doxylamine Succinate And Pyridoxine Hydrochloride. The FDA reported the reason for recall as presence of foreign tablets/capsules. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0822-2026

Reason for Recall
Presence of Foreign Tablets/Capsules
Initiated
08-07-2026
Reported
09-09-2026
Quantity
14,232 bottles (1,423,200 tablets)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
99551
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Bionpharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
US Nationwide.
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

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

Affected Packages Involved in this Recall

69452-206-20 Doxylamine Succinate And Pyridoxine Hydrochloride