FDA Drugs recall ·
Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10… recall
- Recall number
- D-0822-2026
- Date
- (initiated August 7, 2026)
- Company / brand
- Bionpharma Inc.
400 Alexander Park Ste 2-4b, Princeton, NJ, United States - Category
- Drugs › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- 14,232 bottles (1,423,200 tablets)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Presence of Foreign Tablets/Capsules
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot # DMA25006, Exp Date: 11/30/2028.
Distribution
US Nationwide.
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (drugs), recall D-0822-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.