Class II
Ongoing
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
This recall is currently active, issued July 23, 2025. It was issued by Lupin Pharmaceuticals Inc..
- Company
- Lupin Pharmaceuticals Inc.
- Recall Initiated
- June 20, 2025
- Posted
- July 23, 2025
- Recall Number
- D-0532-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 58,968 bottles
- Firm Location
- Naples, FL, United States
- Official Source
- View on FDA website ↗
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.
Distribution
Product was distributed nationwide within the United States.
Lot / Code Info
Lot #: QA01081, Exp. Date April 2027
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