Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg recall
FDA recall D-0822-2026 · initiated Aug 7, 2026
Bionpharma Inc. recalled Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg in Aug 2026 — an FDA Class III recall (D-0822-2026) because Presence of Foreign Tablets/Capsules.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Presence of Foreign Tablets/Capsules
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 14,232 bottles (1,423,200 tablets)
Details
- 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.
- Recalling company
- Bionpharma Inc
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- US Nationwide.
- Initiated
- Aug 7, 2026
- FDA report date
- Sep 9, 2026
Frequently asked
- Was Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg recalled?
- Bionpharma Inc. recalled Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg in Aug 2026 — an FDA Class III recall (D-0822-2026) because Presence of Foreign Tablets/Capsules. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg recalled?
- Per the FDA enforcement record, the reason for recall D-0822-2026 was: Presence of Foreign Tablets/Capsules
- Is a recalled Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg are affected?
- Distributed: US Nationwide.. The recall covers these lots — Lot # DMA25006, Exp Date: 11/30/2028.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0822-2026.