The Recall Desk
HighFDA (Drugs)·D-1287-2022·Announced 2022-08-03

Lansoprazole tablets recalled nationwide due to failed dissolution specifications

Dr. Reddy's Laboratories is recalling Lansoprazole 15-mg delayed-release tablets nationwide due to failed dissolution specifications. The tablets may not dissolve properly, potentially 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 FDA Class II recall involves a manufacturing defect where tablets fail to meet dissolution specifications. No illnesses or hospitalizations have been reported. The defect presents a risk of reduced therapeutic effectiveness.

Plain-English summary

Dr. Reddy's Laboratories is recalling Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, nationwide in the United States. The recall affects 2,892 cartons with Lot T2100514 and expiration date of January 2023. Lansoprazole is a proton pump inhibitor that inhibits gastric acid secretion.

The FDA classified this as a Class II recall due to failed dissolution specifications. The tablets do not dissolve properly, which may affect how the medication functions in the body.

Consumers who have received this medication should check their medication bottle. If you possess Lansoprazole from Lot T2100514 expiring 01/2023 distributed by Dr. Reddy's Laboratories, contact your pharmacist or healthcare provider for guidance.

Do not stop taking your medication without consulting your healthcare provider. Contact your pharmacist or doctor for further instructions regarding this recall.

The recalled product

Product
LANSOPRAZOLE (LANSOPRAZOLE)
Brand
LANSOPRAZOLE
Manufacturer
Dr. Reddy's Laboratories, Inc.
Category
Drug — Proton Pump Inhibitor
Hazard
Affected units
2,892

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 T2100514
  • Exp 01/2023

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Dr. Reddy's Laboratories, 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 · Dr. Reddy's Laboratories, Inc.

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Same hazard · dissolution failure

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