Lisinopril and hydrochlorothiazide bottle contained a foreign antiretroviral tablet
Lisinopril and Hydrochlorothiazide Tablets 20 mg/12.5 mg are being recalled after a complaint that a sealed bottle contained a foreign tablet identified as atazanavir and ritonavir. 58,968 bottles affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Risk-of-harm product: a wrong drug found inside a sealed bottle means a patient could take a medicine that was never prescribed, with no injury reported in the source.
Plain-English summary
Lisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg, 100-count bottles, prescription only, manufactured for Lupin Pharmaceuticals, Inc. of Baltimore, Maryland by Lupin Limited of Nagpur, India, NDC 68180-519-01, are being recalled. The action covers 58,968 bottles.
The stated reason is a product mix up: a complaint was received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20 mg/12.5 mg had a foreign tablet identified as an atazanavir and ritonavir tablet 300 mg/100 mg. The FDA classified the action as Class II.
The affected lot is QA01081, expiring April 2027. Distribution was nationwide within the United States.
Patients holding the affected lot should check their tablets and speak to their pharmacist before taking any tablet that does not match the rest of the bottle. Pharmacies should follow the instructions issued by Lupin.
The recalled product
- Product
- LISINOPRIL AND HYDROCHLOROTHIAZIDE (LISINOPRIL AND HYDROCHLOROTHIAZIDE)
- Brand
- LISINOPRIL AND HYDROCHLOROTHIAZIDE
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Oral tablet
- Affected units
- 58,968
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: QA01081
- Exp. Date April 2027
UPCs (3)
- 0368180519010
- 0368180518013
- 0368180520016
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · LISINOPRIL AND HYDROCHLOROTHIAZIDE
- HighFDA Recalls Lisinopril and Hydrochlorothiazide Tablets Due to Temperature Storage Deviations
FDA (Drugs) · 2024-01-03
- ModerateLupin Recalls Lisinopril and Hydrochlorothiazide Tablets Due to Foreign Substance
FDA (Drugs) · 2019-08-21
- HighLupin Recalls Lisinopril and Hydrochlorothiazide Tablets Due to Foreign Object
FDA (Drugs) · 2019-07-31
- ModerateLupin Recalls Lisinopril and Hydrochlorothiazide Tablets Due to CGMP Deviations
FDA (Drugs) · 2016-07-06
Same manufacturer · Lupin Pharmaceuticals Inc.
See all →- ModerateLupin Recalls Clobetasol Propionate Cream for Content Uniformity Failures
FDA (Drugs) · 2026-09-02
- SevereGlucagon Emergency Kit Recalled for Manufacturing Process Deviation
FDA (Drugs) · 2026-07-08
- HighPrednisolone Acetate Ophthalmic Suspension Recalled for Foreign Substance
FDA (Drugs) · 2026-07-08
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- ModerateGanirelix acetate injection recalled after failing an impurity specification
FDA (Drugs) · 2025-12-17
Same hazard · product mix up
See all →- HighAripiprazole 30mg bottle contained voriconazole 50mg tablets instead
FDA (Drugs) · 2026-06-24
- HighOmeprazole capsule bottle contained a foreign divalproex sodium tablet
FDA (Drugs) · 2025-07-23
- HighKWIK-STICK Quality Control Kit for Culture Media Swab Mix-Up
FDA (Devices) · 2025-06-18
- HighStryker 3.0MM Neuro Precision Head Recalled for Package Labeling Mismatch
FDA (Devices) · 2025-01-29
- ModerateEMPOWR 3D Knee Tibial Insert Recalled for Wrong Product in Package
FDA (Devices) · 2025-01-01