The Recall Desk
HighFDA (Drugs)·D-1288-2022·Announced 2022-08-03

Lansoprazole Delayed-Release Tablets Recalled Nationwide Due to Failed Dissolution Specifications

Dr. Reddy's Laboratories is recalling Lansoprazole 35 mg tablets nationwide because they failed dissolution specifications. The tablets may not release the active ingredient properly, reducing 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: The recall involves a manufacturing defect (failed dissolution specifications) affecting a prescription medication's ability to release and be absorbed properly. This represents a risk-of-harm product where patients may not receive adequate treatment for their medical condition, fitting the Score 3 (High) category per the severity rubric, particularly given the FDA Class II classification and lack of reported illnesses or injuries.

Plain-English summary

Dr. Reddy's Laboratories, Inc. is recalling Lansoprazole Delayed-Release Orally Disintegrating Tablets, 35 mg, distributed nationwide in the United States. The recall affects 2,639 cartons with lot T2100515 and expiration date January 2023. The affected product is identified by NDC 43598-561-78 and blister barcode 4359856179.

The tablets failed to meet FDA dissolution specifications. When a tablet fails dissolution tests, the active ingredient may not be released and absorbed properly, which could result in reduced therapeutic effectiveness of the medication for treating acid reflux and related conditions.

Lansoprazole is a prescription proton pump inhibitor used to reduce stomach acid production and treat gastroesophageal reflux disease (GERD). Patients who have taken tablets from the recalled lot should contact their healthcare provider to discuss their treatment options and possible alternative medications.

Consumers should stop using the recalled tablets and contact their pharmacy or healthcare provider for guidance. The affected product should be returned to the pharmacy or disposed of according to local regulations. No illnesses or injuries have been reported in connection with this recall.

The recalled product

Product
LANSOPRAZOLE (LANSOPRAZOLE)
Brand
LANSOPRAZOLE
Manufacturer
Dr. Reddy's Laboratories, Inc.
Category
Drug — Proton Pump Inhibitor
Hazard
Affected units
2,639

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 T2100515
  • 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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