Lansoprazole Delayed-Release Capsules Recalled for Failed Dissolution Specifications
Dr. Reddy's Laboratories is recalling 7,703 bottles of Lansoprazole Delayed-Release Capsules (30 mg, 90-count) nationwide due to failed dissolution specifications found during long-term stability testing.
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: This FDA Class II recall involves a manufacturing quality defect (failed dissolution specifications) discovered through stability testing. Without documented safety incidents or reported illnesses, this represents a precautionary recall focused on product quality assurance.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling 7,703 bottles of Lansoprazole Delayed-Release Capsules, USP, 30 mg (NDC 55111-399-90) distributed nationwide in the United States. The recall was initiated due to failed dissolution specifications discovered during long-term stability testing.
The recalled product consists of 90-count bottles with Lot # C2102911 and expiration date 12/2023. The product was manufactured by Dr. Reddy's Laboratories Limited in Bachupally, India. Dissolution specifications are quality standards that ensure a medication dissolves appropriately to deliver its therapeutic effect.
Consumers and healthcare providers who have the recalled product should contact their healthcare provider or pharmacist for guidance. Individuals should not stop taking their medication without consulting a healthcare professional.
The recalled product
- Product
- LANSOPRAZOLE (LANSOPRAZOLE)
- Brand
- LANSOPRAZOLE
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Proton Pump Inhibitor
- Hazard
- dissolution-failure
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# C2102911
- Exp. 12/2023
Distribution
Distributed nationwide across the United States.
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