Lisinopril-HCTZ Tablets (Lupin) – CGMP Deviation (2016)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Lisinopril & Hydrochlorothiazide Tables, USP 20mg/12.5mg, packaged in a)100-count bottles and b) 5000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 India, a) NDC 68180-519-01, b) 68180-519-30
Brand
Lupin Pharmaceuticals Inc.
Lot Codes / Batch Numbers
Lot #: a) H303459, b) H303460, Exp 09/2016
Products Sold
Lot #: a) H303459, b) H303460, Exp 09/2016
Lupin Pharmaceuticals Inc. is recalling Lisinopril & Hydrochlorothiazide Tables, USP 20mg/12.5mg, packaged in a)100-count bottles and b) 500 due to CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026