Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg, 100-count bottle, Rx Only, MADE IN INDIA, D
Summary
The FDA issued a Class III for Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg, 100 by Bionpharma Inc.. Reason: Presence of Foreign Tablets/Capsules.
Details
Source
Drug Recall
External ID
D-0822-2026
Action Date
2026-09-09
Status
Ongoing
Category
drug
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.
Lot/Code Info: Lot # DMA25006, Exp Date: 11/30/2028.
Quantity Affected: 14,232 bottles (1,423,200 tablets)
Reason for Recall
Presence of Foreign Tablets/Capsules
Distribution
US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-07
Company
Princeton, NJ
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 53 drug recalls issued in the same week, part of 66 drug-related FDA actions this month.
Bionpharma Inc. has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Bionpharma Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Bionpharma Inc. have FDA actions?
Bionpharma Inc. has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0822-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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