FDA Drug recall D-0487-2024
traMADol Hydrochloride Tablets, USP 50 mg, 1000-count bottle, Rx Only, Distributed by: Advagen Pharma Limited, 666 Plainsboro Road Suite 60…
- FDA Drug
- Class II
- ongoing
- Published 2024-05-15
On 2024-05-15 the FDA classified a Class II recall of traMADol Hydrochloride Tablets, USP 50 mg, 1000-count bottle, Rx Only, Distributed by: Advagen Pharma Limited, 666 Plainsboro Road Suite 60… by Rubicon Research Private, citing presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0487-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-04-26 |
| Published | 2024-05-15 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Rubicon Research Private |
| Distribution | US |
Product
traMADol Hydrochloride Tablets, USP 50 mg, 1000-count bottle, Rx Only, Distributed by: Advagen Pharma Limited, 666 Plainsboro Road Suite 605, Plainsboro, NJ, 08536, USA, Manufactured by: Rubicon Research, Private Limited, Ambernath, Dist. Thane, 421506 India NDC 72888-080-00
Reason
Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol
Identifiers
| ndc | 72888-162-30 |
|---|---|
| ndc | 72888-162-01 |
| ndc | 72888-162-05 |
| ndc | 72888-162-00 |
| ndc | 72888-080-01 |
| ndc | 72888-080-05 |
| ndc | 72888-080-00 |
| ndc | 72888-163-30 |
| ndc | 72888-163-01 |
| ndc | 72888-163-05 |
| ndc | 72888-163-00 |
| ndc | 72888-008-01 |
| ndc | 72888-008-05 |
| ndc | 72888-008-00 |
| code_info | Lot #: 230774Hl, Exp 4/30/2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0487-2024%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.