CLASS II ONGOING Drug recall · Reported 15 May 2024 · FDA Enforcement Report
traMADol Hydrochloride Tablets, USP 50 mg recalled
Rubicon Research Private is recalling traMADol Hydrochloride Tablets, USP 50 mg, distributed nationwide in the US. The recall was initiated on 26 Apr 2024 and the FDA has classified it as Class II.
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-0487-2024
- FDA event ID
- 94467
- Recalling firm
- Rubicon Research Private, Ambarnath, N/A
- Manufacturer
- Advagen Pharma Limited
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 26 Apr 2024
- FDA classified
- 7 May 2024
- Reported
- 15 May 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Pain Medication
Timeline
| 26 Apr 2024 | Recall initiated by company | |
| 7 May 2024 | Classified by FDA | +11 days |
| 15 May 2024 | Published in enforcement report | +8 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: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol
Product as listed by the FDA
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
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol
Which lots are affected?
Lot #: 230774Hl, Exp 4/30/2026
Where was it sold?
Nationwide in the USA
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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 Rubicon Research Private
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | AcetaZOLAMIDE Tablets, USP, 125 mg bottled recalledAcetazolamide | Rubicon Research Private | Other | Nationwide |
| Drug | CLASS II | Metoprolol Tartrate Tablets USP, 25mg recalledMetoprolol Tartrate | Rubicon Research Private | Foreign Material | Nationwide |
| Drug | CLASS II | Metoprolol Tartrate Tablets, USP 25 mg recalledMetoprolol Tartrate | Rubicon Research Private | Foreign Material | Nationwide |
Other Tramadol recalls
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | traMADol Hydrochloride Tablets, USP, 50 mg recalled | Amneal Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | TraMADol HCl, Packaged as (a) recalled by RemedyRepack | RemedyRepack | Packaging Defects | Nationwide |
| Drug | CLASS II | Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose Tablets recalled | The Harvard Drug Group | Packaging Defects | Nationwide |
| Drug | CLASS II | Tramadol Hydrochloride Tablets USP 100mg recalled by Cardinal Health | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS III | Tramadol Hydrochloride Tablets, USP, 50 mg recalled | Golden State Medical Supply | Packaging Defects | Nationwide |