Mylan Recalls Lisinopril Tablets With Incorrect Identifier Codes
Mylan Pharmaceuticals is recalling 2,405 bottles of Lisinopril 10 mg tablets because the pills have the wrong ID code imprinted on them.
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 the product is unlikely to cause adverse health consequences. The defect is a labeling/imprint error without reported harm.
Plain-English summary
Mylan Pharmaceuticals Inc. is recalling 2,405 bottles of Lisinopril Tablets, USP 10 mg. The specific product affected is the 1000-count bottle with NDC 0378-20740-10, Lot # 3002450, and an expiration date of 8/14. The recall is due to the tablets being imprinted with an incorrect identifier code on the embossed surface.
The affected products were distributed nationwide. This recall is classified as Class III by the FDA, indicating that the product is not likely to cause adverse health consequences.
Consumers with this specific lot of Lisinopril should stop using the medication and contact their healthcare provider or pharmacist for a replacement. The incorrect imprint may cause confusion regarding the medication's identity, though the recall notice does not report any illnesses or injuries associated with this defect.
The recalled product
- Product
- Lisinopril Tablets, USP 10 mg, Rx only, 1000 count bottles, Manufactured for: Mylan Pharmaceuticals Inc ,Morgantown, WV 26505 U.S.A. Made in India; NDC 0378-20740-10
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 2,405
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# 3002450
- exp 8/14
Distribution
Distributed nationwide across the United States.
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