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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
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