Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0074-2021·Announced 2020-11-11

Zydus Recalls Lansoprazole Tablets Due to Failed Dissolution Specification

Zydus Pharmaceuticals is recalling 6,840 cartons of Lansoprazole 15 mg tablets because they failed to meet dissolution specifications.

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 temporary or medically reversible adverse health consequence. The failure to meet dissolution specifications is a quality defect that may reduce efficacy but does not present an immediate risk of serious injury or death.

Plain-English summary

Zydus Pharmaceuticals (USA) Inc. is recalling 6,840 units of Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg. The product is distributed in 100-count cartons (10 x 10 unit-dose) and is prescription-only. The specific lot number is M005681 with an expiration date of 3/2022.

The recall was initiated because the product failed to meet dissolution specifications. This means the tablets may not release the medication in the body as intended, potentially affecting the drug's effectiveness. The product was distributed nationwide in the USA.

Consumers with this specific lot of Lansoprazole should stop using it and contact their healthcare provider or pharmacist for a replacement or further instructions.

The recalled product

Product: LANSOPRAZOLE (LANSOPRAZOLE)
Brand: LANSOPRAZOLE
Manufacturer: Zydus Pharmaceuticals (USA) Inc
Category: Drug — Prescription Drug
Hazard: failed-dissolution
Affected units: 6,840

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 # M005681
EXP 3/2022

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Zydus Pharmaceuticals (USA) Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same brand · LANSOPRAZOLE

High
Lansoprazole Delayed-Release Tablets Recalled Nationwide Due to Failed Dissolution Specifications
FDA (Drugs) · 2022-08-03
High
Lansoprazole tablets recalled nationwide due to failed dissolution specifications
FDA (Drugs) · 2022-08-03
High
Lansoprazole Tablets Recalled Due to Failed Dissolution Specifications
FDA (Drugs) · 2022-05-11
Moderate
Lansoprazole Delayed-Release Capsules Recalled for Failed Dissolution Specifications
FDA (Drugs) · 2022-04-06
High
Lansoprazole Capsules Recalled for Failed Dissolution in Stability Testing
FDA (Drugs) · 2022-04-06

Same manufacturer · Zydus Pharmaceuticals (USA) Inc

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