CLASS III ONGOING Drug recall · Reported 9 Sep 2026 · FDA Enforcement Report
Doxylamine Succinate and Pyridoxine HCl Delayed-Release recalled
Bionpharma is recalling Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg, distributed nationwide in the US. The recall was initiated on 7 Aug 2026 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0822-2026
- FDA event ID
- 99551
- Recalling firm
- Bionpharma, Princeton, NJ
- Manufacturer
- Bionpharma Inc.,
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 7 Aug 2026
- FDA classified
- 28 Aug 2026
- Reported
- 9 Sep 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 7 Aug 2026 | Recall initiated by company | |
| 28 Aug 2026 | Classified by FDA | +21 days |
| 9 Sep 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Tablets/Capsules
Product as listed by the FDA
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.
Where it was distributed
US Nationwide.
Questions about this recall
Why was it recalled?
Presence of Foreign Tablets/Capsules
Which lots are affected?
Lot # DMA25006, Exp Date: 11/30/2028.
Where was it sold?
US Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Bionpharma
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|---|---|---|---|---|---|
| Drug | CLASS II | Divalproex Sodium Delayed-Release Tablets, USP, 500 mg recalledDivalproex Sodium | Bionpharma | Other | Nationwide |
| Drug | CLASS I | Atovaquone Oral Suspension, USP 750 mg recalled by BionpharmaAtovaquone | Bionpharma | Sterility | Nationwide |
| Drug | CLASS II | Clobazam Oral Suspension, 2.5 mg/mL recalled by BionpharmaClobazam | Bionpharma | Sterility | Nationwide |
Other Doxylamine recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Doxylamine Succinate and Pyridoxine Hydrochloride recalledDoxylamine Succinate And Pyridoxine Hydrochloride | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |