Lisinopril
FDA Recall NDC 68001-337
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.
The FDA has identified 1 recorded enforcement report(s) associated with Lisinopril (NDC 68001-337). A significant event, classified as Class II, was initiated on Jul 17, 2020 by Bluepoint Laboratories. The reported reason for this action was: "Presence of Foreign Tablets/Capsules: Lisinopril Tablets USP, 20mg found in a 1000 count bottle of Lisinopril Tablets USP, 10mg"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Presence of Foreign Tablets/Capsules: Lisinopril Tablets USP, 20mg found in a 1000 count bottle of Lisinopril Tablets USP, 10mg
Jul 17, 2020
Aug 05, 2020
11,688 bottles
Recall Profile & Regulatory Data
Event ID
86053
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed to OH and may have been further distributed throughout the United States.
Termination Date
Aug 26, 2021
Product Description
Lisinopril Tablets USP, 10 mg, 1000 count bottles, Manufactured by: Lupin Limited, Nagpur INDIA, For BluePoint Laboratories NDC 68001-334-08
Batch or Lot Expiration Information
Lot# Q000232, exp. date 01/2022
Affected Packages Involved in this Recall
68001-337-00Product
68001-337-08Product
68001-332-00Product
68001-332-03Product
68001-333-00Product
68001-333-08Product
68001-486-00Product
68001-486-08Product
68001-334-00Product
68001-334-08Product
68001-335-00Product
68001-335-08Product
68001-336-00Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
