The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0738-2022·Announced 2022-04-06

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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
Affected units
7,703

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.

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.

See all →

Same hazard · dissolution failure

See all →

Similar recalls