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.
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 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
- 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 →Related recalls
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