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Class II · ModerateRecall completed

Lansoprazole

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot # a) C2103093, Exp. 12/2023; b)C2103092, Exp. 12/2023.
Where it was soldNationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed Dissolution Specifications; during long term stability testing.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byDr.Reddy's Laboratories Ltd.
Brand nameLANSOPRAZOLE
Generic nameLANSOPRAZOLE
Active ingredient(s)LANSOPRAZOLE
Distributed by / forDr. Reddy's Laboratories, Inc.
NDC55111-398-30
Show the full FDA record
Full product labelLansoprazole Delayed-Release Capsules, USP, 15 mg, a) 30-count bottle, (NDC 55111-398-30), b) 90-count bottle, (55111-398-90), Rx Only, Manufactured. By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090, India
Recalling firmDr. Reddy's Laboratories, Inc.
DistributionNationwide in the USA
Quantity8,352 bottles (30-count), 1,368 bottles (90-count)
Recall initiated2022-03-23
Report date2022-04-06
Recall completed2024-02-02
Recall numberD-0737-2022
ClassificationClass II
FDA statusTerminated
Origin on filePrinceton NJ United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.