Home / Recalls / Rubicon Research Private Limited / D-0487-2024

D-0487-2024 Class II Ongoing

Recalled by Rubicon Research Private Limited — Ambarnath, N/A

FDA drug recall D-0487-2024 was initiated by Rubicon Research Private Limited on Apr 26, 2024 and is designated Class II. Reason for recall: Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol The recall status is ongoing. Affected quantity: 2,592 1000-count Bottles.

Recall details

Product Type: Drugs
Report Date: May 15, 2024
Initiation Date: Apr 26, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2,592 1000-count Bottles

Product description

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 for recall

Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol

Distribution pattern

Nationwide in the USA

Code information

Lot #: 230774Hl, Exp 4/30/2026

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0487-2024
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.