Accord Healthcare Recalls Lisinopril Tablets Due to Missing Break Line
Accord Healthcare is recalling 12,896 bottles of 5 mg Lisinopril tablets because the tablets are missing a break line. The recall covers the U.S. and Puerto Rico.
What this means for you
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, but the defect is a physical specification failure (missing break line) with no reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Accord Healthcare, Inc. is recalling 12,896 bottles of Lisinopril tablets, 5 mg, 1000-count bottles. The product is prescription-only and was manufactured for Accord Healthcare, Inc. in Durham, NC. The recall is classified as Class II by the FDA.
The reason for the recall is a failed tablet specification: the 5 mg tablets are missing a break line. This defect affects the physical characteristics of the tablet but does not indicate a chemical or biological contamination.
The affected lots are T04483 and T04484 (Exp 2/18), T06028 (Exp 4/18), and T08423 (Exp 5/18). The product was distributed nationwide in the U.S. and in Puerto Rico. Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for guidance on replacement or return.
The recalled product
- Product
- Lisinopril tablets, 5 mg, 1000-count bottle, Rx only, Manufactured for Accord Healthcare, Inc., Durham, NC 27703, NDC 16729-376-17
- Manufacturer
- Accord Healthcare, Inc.
- Category
- Drug — Tablets
- Hazard
- Affected units
- 12,896
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 (7)
- Lot # T04483
- T04484
- Exp 2/18
- T06028
- Exp 4/18
- T08423
- Exp 5/18
Distribution
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