Ramipril Capsules 5mg (Lupin) – CGMP Source Issue (2024)
Class II: 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
Class II recall indicates potential for temporary health effects.
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
Ramipril Capsules USP 5 mg, a) 90 count (NDC 68180-590-09), b) 100 count NDC 68180-590-01), and c) 500 count (NDC 68180-590-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by Lupin Limited, Goa, India
Brand
Lupin Pharmaceuticals Inc.
Lot Codes / Batch Numbers
a) NDC 68180-590-09, Lots G326928, exp. date 30-Sep-25, GA00964, exp. date 31-Dec-25, b) NDC 68180-590-01, Lots G326897, G326929, exp. date 30-Sep-25, GA00854, GA00933, GA00954, exp. date 31-Dec-25, c) NDC 68180-590-02, Lot GA00955, exp. date 31-Dec-25
Products Sold
a) NDC 68180-590-09; Lots G326928, exp. date 30-Sep-25, GA00964, exp. date 31-Dec-25, b) NDC 68180-590-01, Lots G326897, G326929, exp. date 30-Sep-25, GA00854, GA00933, GA00954, exp. date 31-Dec-25, c) NDC 68180-590-02, Lot GA00955, exp. date 31-Dec-25
Lupin Pharmaceuticals Inc. is recalling Ramipril Capsules USP 5 mg, a) 90 count (NDC 68180-590-09), b) 100 count NDC 68180-590-01), and c) 5 due to CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor. 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: Active pharmaceutical ingredient was sourced from an unapproved vendor
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