Lisinopril Tablets, USP 10 mg, 90 tablets per bottle, Rx Only, Distributed by: Walmart, Bentonville, AR 72716, Manufactu
Summary
The FDA issued a Class II for Lisinopril Tablets, USP 10 mg, 90 tablets per bottle, Rx Only, Distributed by: W by Evaric Pharmaceuticals Inc.. Reason: Presence of Foreign Object: A pharmacist discovered a metal fragment embedded in a lisinopril 10 mg tablet..
Details
Source
Drug Recall
External ID
D-0061-2025
Action Date
2024-11-27
Status
Terminated
Category
drug
Product Description
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.
Lot/Code Info: Lot #: 241103, exp. date 05/31/2026
Quantity Affected: 222, 600 bottles
Reason for Recall
Presence of Foreign Object: A pharmacist discovered a metal fragment embedded in a lisinopril 10 mg tablet.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2024-11-15
Company
Hauppauge, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 166 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Evaric Pharmaceuticals Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Evaric Pharmaceuticals Inc. have FDA actions?
This is the only FDA action we have on record for Evaric Pharmaceuticals Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0061-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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