D-0822-2026 Class III Ongoing
FDA drug recall D-0822-2026 was initiated by Bionpharma Inc. on August 7, 2026 and is designated Class III. Reason for recall: Presence of Foreign Tablets/Capsules The recall status is ongoing. Affected quantity: 14,232 bottles (1,423,200 tablets).
Recall Details
- Product Type
- Drugs
- Report Date
- September 9, 2026
- Initiation Date
- August 7, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14,232 bottles (1,423,200 tablets)
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.
Reason for Recall
Presence of Foreign Tablets/Capsules
Distribution Pattern
US Nationwide.
Code Information
Lot # DMA25006, Exp Date: 11/30/2028.