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Recall Observatory FDA recall evidence

Drug product

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

D-0532-2025

June 20, 2025

Class II

Product summary

Firm
Lupin Pharmaceuticals Inc.
Event
Event 97118
Status
Ongoing
Classification
Class II
Quantity
58,968 bottles
Official record key
drug-enforcement:D-0532-2025

Official wording

Reason: 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.

Code information: Lot #: QA01081, Exp. Date April 2027

Distribution pattern: Product was distributed nationwide within the United States.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    foreign tablet