FDA-Drug2026-09-09Class IIIPACKAGING DEFECT
Bionpharma Doxylamine Succinate/Pyridoxine tablets recalled for foreign tablets in bottles
What this means
Bionpharma Inc. is recalling Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets (10 mg/10 mg, 100-count bottles) because some bottles contain unidentified foreign tablets or capsules mixed in with the correct medication. The affected lot is DMA25006 with an expiration date of 11/30/2028. This issue was discovered during quality control.
- Check if you have this medication (NDC 69452-206-20, lot DMA25006, expiration 11/30/2028).
- Do not use the product if foreign tablets or capsules are present in the bottle.
- Contact your pharmacist or doctor for guidance on safely returning or disposing of the medication.
- Contact Bionpharma Inc. or the FDA if you have questions.
The agency's original wording
Hazard
Presence of Foreign Tablets/Capsules
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide.
Affected count
14,232 bottles (1,423,200 tablets)
Manufactured in
400 Alexander Park Ste 2-4b, N/A, Princeton, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0822-2026Want us to check the next one for you?
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