Tramadol Hydrochloride Tablets Recalled Due to Baclofen Contamination
Advagen Pharma is recalling Tramadol Hydrochloride Tablets after a pharmacy discovered baclofen tablets mixed in a bottle of tramadol. This nationwide recall affects 2,592 bottles.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall where baclofen tablets (a different medication) were confirmed to be present in tramadol bottles. No illnesses or injuries have been reported, but the presence of foreign medication poses a significant risk of harm to patients, meeting the rubric criterion for Score 3 (risk-of-harm products where injury has not yet been reported).
Plain-English summary
Advagen Pharma Limited is recalling Tramadol Hydrochloride Tablets, USP 50 mg, in 1000-count bottles due to the presence of foreign tablets in recalled units. A pharmacy reported discovering a tablet of baclofen mixed in with tramadol tablets. Lot #230774Hl with an expiration date of 4/30/2026 is affected.
The presence of foreign medication tablets in the drug bottle poses a serious risk to patients. Patients expecting to receive tramadol may instead receive baclofen, a muscle relaxant with different therapeutic uses, dosing requirements, and potential contraindications.
The recall affects 2,592 1000-count bottles distributed nationwide in the United States. The affected product was manufactured by Rubicon Research Private Limited in India and distributed by Advagen Pharma Limited.
Patients and healthcare providers who have this medication should verify the contents of their bottles. If baclofen or other foreign tablets are found, contact the pharmacy or Advagen Pharma immediately. Do not use the affected medication and consult with a healthcare provider about alternative treatment options.
The recalled product
- Product
- TRAMADOL HYDROCHLORIDE (TRAMADOL HYDROCHLORIDE)
- Brand
- TRAMADOL HYDROCHLORIDE
- Manufacturer
- Rubicon Research Private Limited
- Category
- Drug — Prescription Opioid
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 230774Hl
- Exp 4/30/2026
UPCs (14)
- 0372888163000
- 0372888008059
- 0372888080055
- 0372888163307
- 0372888008011
- 0372888008004
- 0372888162300
- 0372888163055
- 0372888080017
- 0372888162003
- 0372888162010
- 0372888080000
- 0372888163017
- 0372888162058
Distribution
Distributed nationwide across the United States.
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