Lansoprazole Tablets Recalled Due to Failed Dissolution Specifications
Dr. Reddy's Laboratories is recalling Lansoprazole 30 mg orally disintegrating tablets (Lot T2000645) because they failed dissolution specifications. The tablets may not dissolve properly, affecting medication effectiveness.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries, but the failed dissolution specifications represent a risk-of-harm product where the medication may not be effectively absorbed, reducing therapeutic benefit for patients relying on this proton pump inhibitor.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg (NDC 43598-561-78) due to failed dissolution specifications. The affected lot is T2000645 with an expiration date of 07/2022. A total of 252 blister packs were distributed in Ohio.
The tablets failed to meet dissolution specifications, meaning they may not dissolve properly in the digestive tract. This could prevent the medication from being absorbed effectively, reducing its therapeutic effectiveness as a proton pump inhibitor used to treat acid reflux and related conditions.
Patients who have received prescriptions for this specific lot should contact their pharmacy or healthcare provider. Do not discontinue the medication without medical guidance, as this could affect management of your condition. Return unused tablets to your pharmacy for proper disposal.
The recalled product
- Product
- LANSOPRAZOLE (LANSOPRAZOLE)
- Brand
- LANSOPRAZOLE
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug
- 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 #: T2000645
- Exp 07/2022
Distribution
Distributed in 1 state:
- OH
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