Tramadol Hydrochloride Tablet, Coated
FDA Recall NDC 72888-080
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Tramadol Hydrochloride (NDC 72888-080). A significant event, classified as Class II, was initiated on Apr 26, 2024 by Advagen Pharma Limited. The reported reason for this action was: "Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol
Apr 26, 2024
May 15, 2024
2,592 1000-count Bottles
Recall Profile & Regulatory Data
Event ID
94467
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Rubicon Research Private Limited
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
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
Batch or Lot Expiration Information
Lot# : 230774Hl, Exp 4/30/2026
Affected Packages Involved in this Recall
72888-162-30Product
72888-162-01Product
72888-162-05Product
72888-162-00Product
72888-080-01Product
72888-080-05Product
72888-080-00Product
72888-163-30Product
72888-163-01Product
72888-163-05Product
72888-163-00Product
72888-008-01Product
72888-008-05Product
72888-008-00Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
