Agency classClass IIOur severity:Moderate FDA (Drugs)·D-1079-2020·Announced 2020-04-08

Lupin Recalls Lisinopril Tablets Due to Foreign Tablet Mix-Up

Lupin Pharmaceuticals is recalling 25,944 bottles of Lisinopril 30 mg tablets because a 5 mg tablet was found mixed into a 30 mg bottle.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation that might cause temporary or medically reversible adverse health consequences. The hazard is a mix-up of a lower-dose tablet (5 mg) into a higher-dose bottle (30 mg), which is a labeling/packaging error rather than a high-risk contamination or structural defect.

Plain-English summary

Lupin Pharmaceuticals, Inc. is recalling 25,944 bottles of Lisinopril Tablets USP, 30 mg, 100-count. The recall was initiated after a product complaint indicated that one 5 mg lisinopril tablet was found inside a bottle intended to contain only 30 mg tablets.

The affected product is identified by Lot # Q900580 with an expiration date of 9/2021. The recall covers distribution across the U.S.A. nationwide. The specific NDC for the recalled 30 mg, 100-count bottle is 68180-982-01.

Consumers who have this specific lot of Lisinopril 30 mg tablets should stop using them and contact their pharmacist or healthcare provider for guidance on obtaining a replacement. The recall is classified as FDA Class II.

The recalled product

Product: LISINOPRIL (LISINOPRIL)
Brand: LISINOPRIL
Manufacturer: Lupin Pharmaceuticals Inc.
Category: Drug — Prescription Drug
Hazard: foreign-object
dosage-error
Affected units: 25,944

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 #: Q900580
Exp 9/2021

UPCs (3)

0368180513018
0368180512028
0368180513032

Distribution

Distributed nationwide across the United States.

Same brand · LISINOPRIL

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Lisinopril Tablets Recalled for Embedded Metal Contamination
FDA (Drugs) · 2022-09-21
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Lupin Recalls Lisinopril Tablets Due to Foreign Tablet Presence
FDA (Drugs) · 2020-08-05
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Lupin Recalls Lisinopril 5 mg Tablets Due to Product Mix-Up
FDA (Drugs) · 2020-06-17
Severe
Lupin Recalls Lisinopril Tablets Due to Metal Contaminant
FDA (Drugs) · 2018-08-22

Same manufacturer · Lupin Pharmaceuticals Inc.

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