Bionpharma Doxylamine Succinate/Pyridoxine tablets recalled for foreign tablets in bottles
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.
From the FDA notice · Read the official notice ↗
What to do
- 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.
Is yours affected?
Compare your label or packaging with the recalled product.
- 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.
- Sold in
- Nationwide
- Made for
- Adults
Details
- Units affected
- 14,232 bottles (1,423,200 tablets)
- Illnesses reported
- None reported
- Manufactured in
- 400 Alexander Park Ste 2-4b, N/A, Princeton, NJ, United States
- Classification
- Class III
- Recall number
- D-0822-2026
In the FDA's words
- 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. Presence of Foreign Tablets/Capsules Lot # DMA25006, Exp Date: 11/30/2028. Distribution: US Nationwide. Affected quantity: 14,232 bottles (1,423,200 tablets)
- Hazard
- Presence of Foreign Tablets/Capsules