CLASS III ONGOING Drug recall · Reported 15 Jan 2025 · FDA Enforcement Report
Methadone Hydrochloride Tablets, USP, 5mg, Unit-Dose Tablets recalled
West-Ward Columbus is recalling Methadone Hydrochloride Tablets, USP, 5mg, Unit-Dose Tablets, distributed nationwide in the US. The recall was initiated on 19 Dec 2024 and the FDA has classified it as Class III.
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-0183-2025
- FDA event ID
- 95999
- Recalling firm
- West-Ward Columbus, Columbus, OH
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 19 Dec 2024
- FDA classified
- 3 Jan 2025
- Reported
- 15 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 19 Dec 2024 | Recall initiated by company | |
| 3 Jan 2025 | Classified by FDA | +15 days |
| 15 Jan 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.
Product as listed by the FDA
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
Where it was distributed
US Nationwide.
Questions about this recall
Is Methadone Hydrochloride Tablets, USP, 5mg, Unit-Dose Tablets recalled?
Yes. West-Ward Columbus recalled Methadone Hydrochloride Tablets, USP, 5mg, Unit-Dose Tablets on 19 Dec 2024. The recall is Class III and its status is Ongoing. Recall number D-0183-2025.
Why was it recalled?
Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.
Which lots are affected?
Lot # AC2556A; Exp. 03/2027
Where was it sold?
US Nationwide.
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 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 West-Ward Columbus
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|---|---|---|---|---|---|
| Drug | CLASS III | Methotrexate Tablets, USP, 5 mg, Unit-Dose Tablets recalledMethotrexate Sodium | West-Ward Columbus | Other | MS, OH |
| Drug | CLASS III | Leucovorin Calcium Tablets USP, 10 mg recalled by West-Ward ColumbusLeucovorin Calcium | West-Ward Columbus | Other | MS, OH |
| Drug | CLASS II | Doxycycline Hyclate Tablets USP, 100 mg recalled by West-Ward ColumbusDoxycycline Hyclate | West-Ward Columbus | Potency & Assay | Nationwide |
| Drug | CLASS III | Ethacrynic Acid Tablets USP, 25 mg recalled by West-Ward Columbus | West-Ward Columbus | Potency & Assay | Nationwide |
| Drug | CLASS II | Oxcarbazepine Oral Suspension, USP, 300 mg recalled | West-Ward Columbus | Potency & Assay | Nationwide |
Other Methadone recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Methadone HCl Injection in all strengths, all doses recalled | Pharmedium Services | Sterility | Nationwide |
| Drug | CLASS II | Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II, a.) recalledMethadone Hydrochloride | VistaPharm | Sterility | Nationwide |
| Drug | CLASS II | Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II recalledMethadone Hydrochloride | VistaPharm | Sterility | Nationwide |
| Drug | CLASS II | Methadone Hydrochloride Oral Concentrate, USP 5 mg/ C-II recalled | VistaPharm | Sterility | Nationwide |