Zydus Recalls Lansoprazole Tablets for Failed Dissolution Specification
Zydus Pharmaceuticals is recalling 7,908 cartons of Lansoprazole 30 mg tablets because they failed to meet dissolution specifications.
What this means for you
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 may cause temporary or medically reversible adverse health consequences. The specific defect is a failed dissolution specification, which is a quality control issue rather than a direct contamination or acute hazard like a high-risk pathogen.
Plain-English summary
Zydus Pharmaceuticals (USA) Inc. is recalling 7,908 units of Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 100-count cartons. The product is identified by Lot # M005682 and an expiration date of 3/2022. The recall was initiated because the product failed to meet dissolution specifications.
The affected medication is a prescription-only proton pump inhibitor manufactured by Cadila Healthcare Ltd. in Ahmedabad, India, and distributed by Zydus Pharmaceuticals USA Inc. in Pennington, NJ. The recall covers products distributed nationwide in the USA.
Consumers with this specific lot of medication should stop using it and contact their healthcare provider or pharmacist for guidance on replacement or disposal.
The recalled product
- Product
- LANSOPRAZOLE (LANSOPRAZOLE)
- Brand
- LANSOPRAZOLE
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 7,908
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 # M005682
- 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 →Related recalls
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