The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0146-2021·Announced 2020-12-23

Zydus Recalls Lansoprazole Tablets for Failed Dissolution Specifications

Zydus Pharmaceuticals is recalling 22,848 cartons of Lansoprazole 30 mg tablets nationwide 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 due to failed dissolution specifications, which is a quality control issue that may lead to temporary or medically reversible adverse health consequences, fitting the 'Moderate' severity criteria for low-risk contamination or voluntary precautionary recalls without reported injuries.

Plain-English summary

Zydus Pharmaceuticals (USA) Inc. is recalling 22,848 cartons of Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg. The product is distributed nationwide and is available in 100-tablet blister packs (10 x 10 unit-dose). The recall is due to the tablets failing to meet dissolution specifications.

The affected lots are M900412 (December 2020), M904772 (February 2021), and M915745 (October 2021). The product is manufactured by Cadila Healthcare Ltd. in Ahmedabad, India, and distributed by Zydus Pharmaceuticals USA Inc. in Pennington, NJ. The NDC for the recalled product is 68382-772-77.

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance. The FDA classifies this recall as Class II, indicating a situation in which use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
LANSOPRAZOLE (LANSOPRAZOLE)
Brand
LANSOPRAZOLE
Manufacturer
Zydus Pharmaceuticals (USA) Inc
Category
Drug — Prescription Drug
Hazard
Affected units
22,848

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 (1)

  • M900412 December 2020 M904772 February 2021 M915745 October 2021

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 →

Related recalls

Same brand · LANSOPRAZOLE

Same manufacturer · Zydus Pharmaceuticals (USA) Inc

See all →

Same hazard · failed dissolution

See all →

Similar recalls