FDA Drug recall D-0822-2026
Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg, 100-count bottle, Rx Only, MADE IN INDIA, Distributed by: Bion…
- FDA Drug
- Class III
- ongoing
- Published 2026-09-09
On 2026-09-09 the FDA classified a Class III recall of Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg, 100-count bottle, Rx Only, MADE IN INDIA, Distributed by: Bion… by Bionpharma, citing presence of Foreign Tablets/Capsules.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0822-2026 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2026-08-07 |
| Published | 2026-09-09 |
| Last updated | 2026-09-15 05:30 UTC |
| Company | Bionpharma |
| Distribution | US |
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.
Reason
Presence of Foreign Tablets/Capsules
Identifiers
| ndc | 69452-206-20 |
|---|---|
| code_info | Lot # DMA25006, Exp Date: 11/30/2028. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-15 05:30 UTC. Current status: ongoing.
Other recalls by Bionpharma
- Divalproex Sodium Delayed-Release Tablets, USP, 500 mg, 500 Tablets bottles, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540,…
FDA Drug · Class II · 2026-07-29 · Bionpharma - Atovaquone Oral Suspension, USP 750 mg/5 mL, 210 mL bottle, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, NDC # 69452-252-…
FDA Drug · Class I · 2024-10-23 · Bionpharma - Clobazam Oral Suspension, 2.5 mg/mL, 120 mL bottle, Rx only, Distributed by: Bionpharma Inc., 600 Alexander Road, Princeton, NJ 08540, NDC…
FDA Drug · Class II · 2019-07-31 · Bionpharma
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0822-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.