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Class III · Lower riskRecall completed

Lisinopril

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberBatch number: H303487, H303488, H303489, Exp 09/16
Where it was soldAll product distributed domestically in the US. No recalled product was distributed to U.S. Government Agency consignees directly by Lupin. No recalled product was distributed to any foreign consignees by Lupin.
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

CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed 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 byLupin Limited, Pithampur (M.P.) 454 775, INDIA foreign manufacturer
Brand nameLISINOPRIL
Generic nameLISINOPRIL
Active ingredient(s)LISINOPRIL
Distributed by / forLupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States;
NDC68180-516-02
Show the full FDA record
Full product labelLisinopril Tablets USP, 30 mg, packaged in a) 500-count bottles (NDC 68180-516-02) and b) 100-count bottles (NDC 68180-516-01); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States; Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA.
Recalling firmLupin Pharmaceuticals Inc.
DistributionAll product distributed domestically in the US. No recalled product was distributed to U.S. Government Agency consignees directly by Lupin. No recalled product was distributed to any foreign consignees by Lupin.
Quantity20,556 bottles
Recall initiated2016-04-06
Report date2016-09-28
Recall completed2017-08-07
Recall numberD-1502-2016
ClassificationClass III
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.