URGENT: Drug RECALL re: Doxylamine Succinate and Pyridoxine HCI
- HOPE Clinic
- 7 days ago
- 3 min read
Bionpharma Inc.
400 Alexander Park Suite 2-4B
Princeton, NJ 08540
Phone: 609-380-3310
Date: August 7, 2026
URGENT: DRUG RECALL
RE: Doxylamine Succinate and Pyridoxine HCI Delayed-Release tablets 10 mg/10 mg
(NDC # 69452-206-20, Lot # DMA25006, Exp. 11/2028, lOO's count)
Dear Valued Customer,
We are writing to inform you of a product recall being conducted voluntarily by Bionpharma Inc. for one lot of Doxylamine Succinate and Pyridoxine HCI Delayed-Release tablets 10 mg/10 mg distributed between 4-1-2026 and 7-7-2026. Bionpharma has initiated a recall of the impacted lot, and it is being conducted in cooperation with the Food and Drug Administration (FDA).
NOC# | Impacted Lot# | Expir,y Date |
69452-206-Z0 | DMA25006 | 11/2028 |
A single foreign tablet was found in one l00's count bottle of the above-referenced lot of the product. Based on the investigation, this is an isolated incident with an extremely low frequency of occurrence. The foreign tablet is readily distinguishable from Doxylamine Succinate and Pyridoxine HCI DelayedRelease tablets 10 mg/10 mg based on their physical characteristics, including color (white vs. pink), size (8 mm vs 7 mm) and imprint (DP 1 vs B 10}. So, one product cannot be mistaken for another. However, out of an abundance of caution, Bionpharma has decided to recall the batch to the retail level.
See enclosed product label for ease in identifying the product at the retail level.
It is important to note that Bionpharma has not received any adverse event reports to date relating to this issue and no other lot of Bionpharma's Doxylamine Succinate and Pyridoxine HCI Delayed-Release tablets 10 mg/10 mg is impacted by this recall.
We request that you take the following actions:
1. Immediately cease distribution of the drug product from the affected lot (Lot # DMA25006} and remove it from active inventory.
2. Please contact our Recall Coordinator and promptly return the attached "Recall Response Form" at the below email address or fax or via mail. Please send the Recall Response Form even if you do not have any product from the affected lot.
Qualanex, LLC
Qualanex Recall# 513
1410 Harris Road
Libertyville, IL 60048
Phone: 800-505-9291 (Mon-Fri 9AM-5PM CST); Fax: 847-737-3719
Email: recall@gualanex.com
If you have any product from the affected lot, please contact the Recall Coordinator for issuance of a Return Authorization (RA) Form. The RA Form provided will contain all information required to return affected lot (Lot DMA25006) of Doxyfamine Succinate and Pyridoxine HCI Delayed-Release tablets 10 mg/10 mg.
3. Credit for any returned merchandise, along with shipping charges, will be reimbursed by credit memo.
4. If you have supplied the impacted lot to retail pharmacies, please take the following steps:
a. Please forward this Recall Letter along with the attached Recall Response Form to the retailer.
b. Instruct the retailer to immediately cease distribution of the drug product from the affected lot (Lot# DMA25006) and remove it from active inventory.
c. Instruct the retailer to complete the attached Recall Response Form and send it to Bionpharma (as explained in #2 above).
If you have any further questions, please feel free to contact me at 919-396-6016 (Mon-Fri 9AM-SPM). Our primary concern is always for the health and safety of our customers.
We appreciate your cooperation and sincerely regret any inconvenience caused by this action.
Kind Regards,
Jerri Lubke
Director, Sales Operations
Bionpharma Inc.
2250 Perimeter Park Drive,
Suite 100, Morrisville, NC 27560
400 Alexander Park, Suite 2-4B, Princeton, NJ 08540
Click below to View the Recall Letter from the Manufacturer & the Product Label