The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0145-2021·Announced 2020-12-23

Zydus Recalls Lansoprazole Tablets for Failed Dissolution Specifications

Zydus Pharmaceuticals is recalling 15,144 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text identifies the agency classification as Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), as they may cause temporary or medically reversible adverse health consequences.

Plain-English summary

Zydus Pharmaceuticals (USA) Inc. is recalling 15,144 cartons of Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg. The product is distributed nationwide and is available in 100-tablet blister packs. The recall is due to the tablets failing to meet dissolution specifications.

The affected product is a prescription-only medication manufactured by Cadila Healthcare Ltd. in Ahmedabad, India, and distributed by Zydus Pharmaceuticals USA Inc. in Pennington, NJ. The specific NDC for the recalled packaging is 68382-771-77. The recall involves lots with codes M915744 (October 2021) and M904770 (February 2021).

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance. The FDA classifies this as a Class II recall, indicating a situation where 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
15,144

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)

  • M915744 OCT 2021 M904770 FEB 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

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Same hazard · failed dissolution

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