FDA Recall D-0532-2025

Lupin Pharmaceuticals Inc. · Naples, FL

Class II Ongoing 328 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

Lot / code: Lot #: QA01081, Exp. Date April 2027

Quantity: 58,968 bottles

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.

Recall record

Recall number: D-0532-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: N/A
Distribution: Product was distributed nationwide within the United States.
Recall initiated: 2025-06-20
Classified by FDA Center: 2025-07-17
FDA published: 2025-07-23
Recalling firm: Lupin Pharmaceuticals Inc.
Firm location: Naples, FL

Drug identification

Brand name(s): LISINOPRIL AND HYDROCHLOROTHIAZIDE
Generic name(s): LISINOPRIL AND HYDROCHLOROTHIAZIDE
Manufacturer(s): Lupin Pharmaceuticals, Inc.
NDC(s): 68180-518, 68180-519, 68180-520
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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