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Class II · ModerateRecall completed

Lisinopril

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

Does this affect you?
Check your lot numberLot # Q201182, exp. date March 2024
Where it was soldProduct was distributed to major distributors/wholesalers nationwide.
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

Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.

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 byLupin Limited, Nagpur- 441 108, India foreign manufacturer
Brand nameLISINOPRIL
Generic nameLISINOPRIL
Active ingredient(s)LISINOPRIL
Distributed by / forLupin Pharmaceuticals, Inc. Baltimore, Maryland 21202
NDC68180-980-03
Show the full FDA record
Full product labelLisinopril Tablets USP, 10 mg, 1000-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Nagpur- 441 108, India. NDC 68180-980-03
Recalling firmLupin Pharmaceuticals Inc.
DistributionProduct was distributed to major distributors/wholesalers nationwide.
Quantity11,802 1000-count bottles
Recall initiated2022-09-13
Report date2022-09-21
Recall completed2024-01-31
Recall numberD-1536-2022
ClassificationClass II
FDA statusTerminated
Origin on fileBaltimore MD 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.