Lupin Recalls Lisinopril and Hydrochlorothiazide Tablets Due to Foreign Object
Lupin Pharmaceuticals is recalling 11,832 bottles of Lisinopril and Hydrochlorothiazide tablets because a foreign tablet was found in the product.
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: The recall involves a risk-of-harm product (foreign object in medication) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Lupin Pharmaceuticals, Inc. is recalling 11,832 bottles of Lisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg, 500-count. The recall is due to a product complaint reporting the presence of one Fenofibrate tablet 145mg in a 500-count product bottle.
The affected product is identified by Lot #H801815 with an expiration date of March 2021. The product was distributed nationwide within the United States. The tablets are manufactured for Lupin Pharmaceuticals, Inc. in Baltimore, Maryland, and manufactured by Lupin Limited in Pithampur, India.
Consumers should check their medication for the specific lot number and expiration date. If the product matches the description, they should stop using it and contact their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- LISINOPRIL AND HYDROCHLOROTHIAZIDE (LISINOPRIL AND HYDROCHLOROTHIAZIDE)
- Brand
- LISINOPRIL AND HYDROCHLOROTHIAZIDE
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 11,832
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 #:H801815
- Exp. March 2021
UPCs (3)
- 0368180519010
- 0368180518013
- 0368180520016
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · LISINOPRIL AND HYDROCHLOROTHIAZIDE
- HighLisinopril and hydrochlorothiazide bottle contained a foreign antiretroviral tablet
FDA (Drugs) · 2025-07-23
- 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
- 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 · foreign object
See all →- SevereOutshine Strawberry Fruit Bars Recalled for Potential Glass Contamination
FDA (Food) · 2026-09-02
- SevereOutshine Black Cherry Fruit Bars Recalled for Potential Glass Contamination
FDA (Food) · 2026-09-02
- SevereOutshine Fruit Bars Recalled for Potential Glass Contamination
FDA (Food) · 2026-09-02
- SevereOutshine Fruit Bars Grape Recalled for Potential Glass Contamination
FDA (Food) · 2026-09-02
- SevereOutshine Watermelon Fruit Bars Recalled for Potential Glass Contamination
FDA (Food) · 2026-09-02