West-Ward Recalls Lisinopril Tablets Due to Impurity Test Failures
West-Ward Pharmaceutical Corp. is recalling 51,704 bottles of Lisinopril Tablets, USP, 2.5 mg because they failed impurity specifications at the 48-month time point.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
West-Ward Pharmaceutical Corp. is recalling 51,704 bottles of Lisinopril Tablets, USP, 2.5 mg, Rx only. The affected products are packaged in 100-count and 1,000-count bottles and were distributed nationwide. The recall involves specific lot numbers and expiration dates ranging from August 2013 to May 2016, manufactured by West-Ward Pharmaceutical Corp. in Eatontown, N.J., and manufactured for Blu Pharmaceuticals in Franklin, KY.
The recall was initiated because the products failed impurities and degradation specifications. Specifically, out-of-specification results were obtained for individual other unknown related compounds at the 48-month time point. This indicates that the chemical stability of the medication did not meet required standards over the long term.
Consumers and healthcare providers should stop using the affected Lisinopril Tablets and return them to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if necessary.
The recalled product
- Product
- Lisinopril Tablets, USP, 2.5 mg, Rx only, packaged in a) 100-count bottles (NDC 0143-1265-01) and b) 1000-count bottles (NDC 0143-1265-10), Manufactured by: West-ward Pharmaceutical Corp., Eatontown, N.J. 07724; and c) 1000-count bottles (NDC 24658-240-10), Manufactured for: Blu…
- Manufacturer
- West-Ward Pharmaceutical Corp.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 51,704
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 (20)
- Lot #: a) 68679A
- 68679C
- Exp 01/15
- 64456A
- Exp 04/15
- 68980A
- Exp 05/15
- 69234A
- 69235A
- Exp 07/15
- 69607A
- Exp 11/15
- 69609C
- 69835A
- Exp 01/16
- b) 64455B
- Exp 08/13
- 64456C
- Exp 04/14
- 64457A
Distribution
Distributed nationwide across the United States.
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