traMADol Hydrochloride Tablets recall
FDA recall D-0487-2024 · initiated Apr 26, 2024
Rubicon Research Private Limited recalled traMADol Hydrochloride Tablets in Apr 2024 — an FDA Class II recall (D-0487-2024) because Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 2,592 1000-count Bottles
Details
- 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
- Recalling company
- Rubicon Research Private Limited
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Apr 26, 2024
- FDA report date
- May 15, 2024
Frequently asked
- Was traMADol Hydrochloride Tablets recalled?
- Rubicon Research Private Limited recalled traMADol Hydrochloride Tablets in Apr 2024 — an FDA Class II recall (D-0487-2024) because Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was traMADol Hydrochloride Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0487-2024 was: Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol
- Is a recalled traMADol Hydrochloride Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of traMADol Hydrochloride Tablets are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot #: 230774Hl, Exp 4/30/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0487-2024.