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Class II · ModerateActive recall

Lisinopril And Hydrochlorothiazide

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

Does this affect you?
Check your lot numberLot #: QA01081, Exp. Date April 2027
Where it was soldProduct was distributed nationwide 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

Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg.

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 AND HYDROCHLOROTHIAZIDE
Generic nameLISINOPRIL AND HYDROCHLOROTHIAZIDE
Active ingredient(s)HYDROCHLOROTHIAZIDE, LISINOPRIL
Distributed by / forLupin Pharmaceuticals Inc.
NDC68180-519-01
Show the full FDA record
Full product labelLisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles, Rx only, Mfg for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, Manufactured by: Lupin Limited Nagpur-441 108, INDIA, NDC 68180-519-01
Recalling firmLupin Pharmaceuticals Inc.
DistributionProduct was distributed nationwide within the United States.
Quantity58,968 bottles
Recall initiated2025-06-20
Report date2025-07-23
Recall completed
Recall numberD-0532-2025
ClassificationClass II
FDA statusOngoing
Origin on fileNaples FL 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.