D-0532-2025 Class II
FDA drug recall D-0532-2025 was initiated by Lupin Pharmaceuticals Inc. on Jun 20, 2025 and is designated Class II. 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… Affected quantity: 58,968 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 23, 2025
- Initiation Date
- Jun 20, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 58,968 bottles
Product Description
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
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 Pattern
Product was distributed nationwide within the United States.
Code Information
Lot #: QA01081, Exp. Date April 2027
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0532-2025
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026