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Class II · ModerateRecall completed

Lisinopril And Hydrochlorothiazide

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

Does this affect you?
Check your lot numberLot #:H801815, Exp. March 2021
Where it was soldNationwide within the United States
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 Tablets/Capsules: Product complaint received of one Fenofibrate tablet 145mg observed in 500 s count product bottle.

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 AND HYDROCHLOROTHIAZIDE
Generic nameLISINOPRIL AND HYDROCHLOROTHIAZIDE
Active ingredient(s)HYDROCHLOROTHIAZIDE, LISINOPRIL
Distributed by / forLupin Pharmaceuticals, Inc. Baltimore, Maryland 21202
NDC68180-519-02
Show the full FDA record
Full product labelLisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg, 500-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, INDIA, NDC 68180-519-02
Recalling firmLupin Pharmaceuticals Inc.
DistributionNationwide within the United States
Quantity11,832 bottles
Recall initiated2019-07-19
Report date2019-07-31
Recall completed2020-09-09
Recall numberD-1581-2019
ClassificationClass II
FDA statusTerminated
Origin on fileBaltimore MD United States

Related

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.