November 2024 FDA Recall Lisinopril by Evaric Pharmaceuticals Inc.
D-0061-2025 - Presence of Foreign Object

This Class II drug recall was voluntarily initiated by Evaric Pharmaceuticals Inc. on November 15, 2024 for the product Lisinopril. The FDA reported the reason for recall as presence of foreign object. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0061-2025

Reason for Recall
Presence of Foreign Object: A pharmacist discovered a metal fragment embedded in a lisinopril 10 mg tablet.
Initiated
11-15-2024
Reported
11-27-2024
Quantity
222, 600 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
95749
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Evaric Pharmaceuticals Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-23-2026
Product Description About Product Description
Full technical description of the product.
Lisinopril Tablets, USP 10 mg, 90 tablets per bottle, Rx Only, Distributed by: Walmart, Bentonville, AR 72716, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045, NDC# 68645-610-90.

Batch or Lot Expiration Information

Lot# : 241103, exp. date 05/31/2026

Affected Packages Involved in this Recall

68645-609-90 Lisinopril
68645-610-90 Lisinopril
68645-611-90 Lisinopril
68645-608-90 Lisinopril
68645-612-90 Lisinopril
68645-613-90 Lisinopril