The Recall Desk
HighFDA (Drugs)·D-0737-2022·Announced 2022-04-06

Lansoprazole Capsules Recalled for Failed Dissolution in Stability Testing

Dr. Reddy's Laboratories is recalling specific lots of Lansoprazole 15 mg delayed-release capsules nationwide because the capsules failed to dissolve properly during long-term stability testing, which could affect 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. The failed dissolution specifications represent a manufacturing defect that could affect medication efficacy, meeting the rubric criterion of 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Dr. Reddy's Laboratories, Inc. is recalling Lansoprazole Delayed-Release Capsules, USP, 15 mg. The recall includes 30-count bottles (lot C2103093) and 90-count bottles (lot C2103092), both expiring 12/2023. The affected products were distributed nationwide in the USA.

The recall was initiated because these capsules failed to meet dissolution specifications during long-term stability testing. Proper dissolution is necessary for the medication to be absorbed effectively in the body. If the capsule does not dissolve correctly, the drug may not work as intended.

Consumers who have bottles from the affected lots should contact their pharmacist or physician. Do not stop taking the medication without consulting a healthcare provider first. Dr. Reddy's Laboratories can provide further information about the recall.

The recalled product

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

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 (4)

  • Lot # a) C2103093
  • Exp. 12/2023
  • b)C2103092
  • 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.

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Same hazard · dissolution failure

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