Sandoz Recalls Lisinopril Tablets Due to Missing Package Insert
Sandoz Inc is recalling 3,048 bottles of Lisinopril Tablets USP, 30 mg, because the package insert is incorrect or missing.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The hazard is a documentation/packaging issue (missing insert) rather than a direct safety risk like contamination or dosage error.
Plain-English summary
Sandoz Inc is recalling 3,048 bottles of Lisinopril Tablets USP, 30 mg, 100-count bottles. The recall is due to a labeling issue where the package insert is incorrect or missing.
The affected product is identified by NDC 0185-0630-01, Lot # FC1960, and an expiration date of 02/18. The recall covers 304,800 tablets distributed nationwide.
Consumers with this product should contact their healthcare provider or pharmacist for guidance. The FDA classifies this as a Class III recall, indicating that the labeling error is unlikely to cause adverse health consequences.
The recalled product
- Product
- Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, NDC 0185-0630-01
- Manufacturer
- Sandoz Inc
- Category
- Drug — Prescription Medication
- 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 # FC1960
- Exp.: 02/18
Distribution
Distributed nationwide across the United States.
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