TraMADol HCl 50 mg Tablet recall
FDA recall D-0489-2024 · initiated May 2, 2024
RemedyRepack Inc. recalled TraMADol HCl 50 mg Tablet in May 2024 — an FDA Class II recall (D-0489-2024) because Presence of Foreign Tablets: Manufacturer received a report from a Pharmacist who reported finding 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: Manufacturer received a report from a Pharmacist who reported finding 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: 23,970 Tablets
Details
- Product
- TraMADol HCl 50 mg Tablet, Packaged as (a) 30-count blister pack, NDC 70518-3824-00; (b) 90-count blister pack, NDC 70518-3824-02; (a) 180-count blister pack, NDC 70518-3824-03; RX ONLY, MFG: Advagen Pharma Limited, Plainsboro. NJ 08536, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, 724.465.8762
- Recalling company
- RemedyRepack Inc.
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- May 2, 2024
- FDA report date
- May 15, 2024
Frequently asked
- Was TraMADol HCl 50 mg Tablet recalled?
- RemedyRepack Inc. recalled TraMADol HCl 50 mg Tablet in May 2024 — an FDA Class II recall (D-0489-2024) because Presence of Foreign Tablets: Manufacturer received a report from a Pharmacist who reported finding 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 HCl 50 mg Tablet recalled?
- Per the FDA enforcement record, the reason for recall D-0489-2024 was: Presence of Foreign Tablets: Manufacturer received a report from a Pharmacist who reported finding a tablet of baclofen in a bottle of 1000-count tramadol
- Is a recalled TraMADol HCl 50 mg Tablet 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 HCl 50 mg Tablet are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lots#: (a)J0732085-101023, Exp (b) B2546618-100523, Exp (c) B2546541-100523. 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-0489-2024.