Agency classClass IIOur severity:High FDA (Drugs)·D-1536-2022·Announced 2022-09-21

Lisinopril Tablets Recalled for Embedded Metal Contamination

Lupin Pharmaceuticals is recalling Lisinopril 10 mg tablets due to discovery of a metal piece embedded in one tablet. Affected lot Q201182 was distributed nationwide to wholesalers.

The agency’s classification

FDA (Drugs): Class II

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.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II drug recall with a physical contaminant (metal piece) embedded in a tablet, posing a risk of harm if ingested. No illnesses or injuries have been reported to date, but the presence of a foreign object in medication represents a legitimate safety hazard.

Plain-English summary

Lupin Pharmaceuticals Inc. is recalling Lisinopril Tablets USP, 10 mg, in 1000-count bottles due to discovery of foreign material (a metal piece) embedded in one tablet.

A metal piece was found embedded within a single tablet in the affected lot, which poses a potential safety risk to consumers if the contaminated tablet is taken.

The recall affects 11,802 bottles of 1000-count Lisinopril tablets (lot # Q201182, expiration date March 2024). The affected product was distributed to major pharmaceutical distributors and wholesalers nationwide. NDC 68180-980-03.

Consumers taking Lisinopril from this lot should contact their pharmacist or healthcare provider. Do not consume tablets from this lot. Return the product to the pharmacy where it was obtained, or contact Lupin Pharmaceuticals for instructions on returning the product.

The recalled product

Product: LISINOPRIL (LISINOPRIL)
Brand: LISINOPRIL
Manufacturer: Lupin Pharmaceuticals Inc.
Category: Drug — Prescription Drug
Hazard: metal-contamination
choking

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 # Q201182
exp. date March 2024

UPCs (3)

0368180513018
0368180512028
0368180513032

Distribution

Distributed nationwide across the United States.

Same brand · LISINOPRIL

High
Lisinopril 10 mg Tablets Recalled for Metal Fragment Contamination
FDA (Drugs) · 2024-11-27
High
Lupin Recalls Lisinopril Tablets Due to Foreign Tablet Presence
FDA (Drugs) · 2020-08-05
High
Lupin Recalls Lisinopril 5 mg Tablets Due to Product Mix-Up
FDA (Drugs) · 2020-06-17
Moderate
Lupin Recalls Lisinopril Tablets Due to Foreign Tablet Mix-Up
FDA (Drugs) · 2020-04-08
Severe
Lupin Recalls Lisinopril Tablets Due to Metal Contaminant
FDA (Drugs) · 2018-08-22

Same manufacturer · Lupin Pharmaceuticals Inc.

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