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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 numberBatch# H900575, exp. date 01/2022
Where it was soldProduct was distributed to wholesalers/distributors and supermarket and drug chains throughout 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 Substance; Product complaints received related to brownish/blackish stains on the tablets and brownish/blackish powder observed inside the bottles.

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 byfor: Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by: Lupin Limited, Pithampur, INDIA foreign manufacturer
Brand nameLISINOPRIL AND HYDROCHLOROTHIAZIDE
Generic nameLISINOPRIL AND HYDROCHLOROTHIAZIDE
Active ingredient(s)HYDROCHLOROTHIAZIDE, LISINOPRIL
Distributed by / forLupin Pharmaceuticals Inc.
NDC68180-518-01
Show the full FDA record
Full product labelLisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg, 100 tablet bottle, Rx only, Manufactured by for: Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by: Lupin Limited, Pithampur, INDIA NDC 68180-518-01
Recalling firmLupin Pharmaceuticals Inc.
DistributionProduct was distributed to wholesalers/distributors and supermarket and drug chains throughout the United States.
Quantity39,216 bottles
Recall initiated2019-07-17
Report date2019-08-21
Recall completed2020-09-14
Recall numberD-1720-2019
ClassificationClass II
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.