DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE
Recalling Firm / Manufacturer: Bionpharma Inc.
(Princeton, NJ, United States)
FDA Recall Number: D-0822-2026
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE
Generic Name
DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE
Active Substance(s)
Doxylamine Succinate, Pyridoxine Hydrochloride
Administration Route
Oral
National Drug Code (NDC)
69452-206
Total Quantity Recalled
14,232 bottles (1,423,200 tablets)
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Presence of Foreign Tablets/Capsules
Full Product Description
Packaging specifications and labeling details
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.
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class III
Current Action Status
Ongoing
FDA Enforcement Report Date
September 09, 2026
Firm Initiation Date
August 07, 2026
FDA Classification Date
Aug 28, 2026
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot # DMA25006, Exp Date: 11/30/2028.
Distribution Information
Geographic scope of affected shipments
US Nationwide.
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Advisory Notice
This Class III recall involves technical or packaging non-conformities that are not expected to cause adverse health consequences. Consult your pharmacist if you have questions.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0822-2026
Questo Retrieval Date: September 15, 2026 00:00 1789430406UTCC