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Class III · Lower riskRecall completed

Lisinopril And Hydrochlorothiazide

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

Does this affect you?
Check your lot numberLot #: a) H303459, b) H303460, Exp 09/2016
Where it was soldNationwide and Puerto Rico
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, a) foreign manufacturer
Brand nameLISINOPRIL AND HYDROCHLOROTHIAZIDE
Generic nameLISINOPRIL AND HYDROCHLOROTHIAZIDE
Active ingredient(s)HYDROCHLOROTHIAZIDE, LISINOPRIL
Distributed by / forLupin Pharmaceuticals, Inc. Baltimore, Maryland 21202
NDC68180-519-01
Show the full FDA record
Full product labelLisinopril & Hydrochlorothiazide Tables, USP 20mg/12.5mg, packaged in a)100-count bottles and b) 5000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 India, a) NDC 68180-519-01, b) 68180-519-30
Recalling firmLupin Pharmaceuticals Inc.
DistributionNationwide and Puerto Rico
Quantity59,520 Bottles
Recall initiated2016-04-04
Report date2016-07-06
Recall completed2017-06-01
Recall numberD-1052-2016
ClassificationClass III
FDA statusTerminated
Origin on fileBaltimore MD United States

Related

Hydrochlorothiazide recallsLisinopril recallsRecent drug recallsCheck another medication

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.