Methadone Hydrochloride Tablets recall
FDA recall D-0183-2025 · initiated Dec 19, 2024
West-Ward Columbus Inc recalled Methadone Hydrochloride Tablets in Dec 2024 — an FDA Class III recall (D-0183-2025) because Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
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: 2591 100-count boxes
Details
- Product
- Methadone Hydrochloride Tablets, USP, 5mg, 10x10 Unit-Dose Tablets, Rx Only, Distributed by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, NDC 0054-0709-20
- Recalling company
- West-Ward Columbus Inc
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- US Nationwide.
- Initiated
- Dec 19, 2024
- FDA report date
- Jan 15, 2025
Frequently asked
- Was Methadone Hydrochloride Tablets recalled?
- West-Ward Columbus Inc recalled Methadone Hydrochloride Tablets in Dec 2024 — an FDA Class III recall (D-0183-2025) because Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Methadone Hydrochloride Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0183-2025 was: Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.
- Is a recalled Methadone 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. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. 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 Methadone Hydrochloride Tablets are affected?
- Distributed: US Nationwide.. The recall covers these lots — Lot # AC2556A; Exp. 03/2027. 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-0183-2025.