Methadone Hydrochloride Tablets recalled for illegible product identification
West-Ward Columbus is recalling Methadone Hydrochloride Tablets, 5mg, in unit-dose packaging due to illegible product identification on individual tablets. Lot AC2556A was distributed nationwide.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Class III recall with no reported illnesses or injuries. Illegible identification on tablets is a labeling defect affecting a controlled substance. Class III recalls are typically scored 1-2; this labeling error places it at Moderate (2).
Plain-English summary
West-Ward Columbus Inc. is recalling Methadone Hydrochloride Tablets, USP, 5mg, in unit-dose packaging due to illegible product identification on the tablets. The product identification marking on individual tablets in the unit-dose configuration cannot be read clearly, preventing visual verification of the tablet strength.
The affected product is Lot AC2556A with an expiration date of March 2027. Approximately 2,591 100-count boxes were distributed nationwide through Hikma Pharmaceuticals USA Inc., Berkeley Heights, New Jersey.
Patients currently taking methadone from this lot should verify their medication with their pharmacy or healthcare provider to confirm they have the correct product and dosage. Healthcare providers and patients with questions about this recall should contact West-Ward Columbus Inc. for additional information.
The recalled product
- Product
- METHADONE HYDROCHLORIDE (METHADONE HYDROCHLORIDE)
- Brand
- METHADONE HYDROCHLORIDE
- Manufacturer
- West-Ward Columbus Inc
- Category
- Drug — Opioid
- Hazard
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 # AC2556A
- Exp. 03/2027
UPCs (2)
- 0300540709259
- 0300540710255
Distribution
Distributed nationwide across the United States.
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