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Drug FDA Class II Ongoing Chemical

Lisinopril 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

Lupin Pharmaceuticals Inc. Published Jul 23, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Lupin Pharmaceuticals Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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.

Hazards

Atazanavir and Ritonavir · primary

Affected products (1)

Lisinopril 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

LISINOPRIL AND HYDROCHLOROTHIAZIDE · 58,968 bottles

NDC: 68180-518, 68180-519, 68180-520, 68180-518-02, 68180-518-01, 68180-518-30, 68180-519-30, 68180-519-01, 68180-519-02, 68180-520-02, 68180-520-30, 68180-520-01
Code info: Lot #: QA01081, Exp. Date April 2027

Affected areas

Nationwide

Timeline

  1. Initiated
    Jun 20, 2025
  2. Published
    Jul 23, 2025
Recall number
D-0532-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.