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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 numberM915744 OCT 2021 M904770 FEB 2021
Where it was soldNationwide
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

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 byCadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 foreign manufacturer
Brand nameLANSOPRAZOLE
Generic nameLANSOPRAZOLE
Active ingredient(s)LANSOPRAZOLE
Distributed by / forZydus Pharmaceuticals USA Inc. Pennington, NJ 08534
NDC68382-771-77
Show the full FDA record
Full product labelLansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100 Tablets (10x10 unit dose) blister pack, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 NDC 68382-771-77
Recalling firmZydus Pharmaceuticals (USA) Inc
DistributionNationwide
Quantity15,144 cartons
Recall initiated2020-12-03
Report date2020-12-23
Recall completed2022-12-20
Recall numberD-0145-2021
ClassificationClass II
FDA statusTerminated
Origin on filePennington 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.