Ramipril Capsule
FDA Recall NDC 68180-588
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Ramipril (NDC 68180-588). A significant event, classified as Class II, was initiated on Oct 23, 2024 by Lupin Pharmaceuticals, Inc.. The reported reason for this action was: "CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Oct 23, 2024
Nov 27, 2024
146,322 bottles
Recall Profile & Regulatory Data
Event ID
95610
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed to 30 wholesalers/distributors who may have further distributed the product nationwide.
Termination Date
Jan 05, 2026
Product Description
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
Batch or Lot Expiration Information
Lot# 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
Affected Packages Involved in this Recall
68180-589-09Product
68180-589-10Product
68180-589-01Product
68180-589-02Product
68180-590-09Product
68180-590-10Product
68180-590-01Product
68180-590-02Product
68180-591-09Product
68180-591-10Product
68180-591-02Product
68180-591-01Product
68180-588-01Product
68180-588-02Product
68180-588-09Product
Class II Terminated
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Oct 23, 2024
Nov 27, 2024
357,414 bottles
Recall Profile & Regulatory Data
Event ID
95610
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed to 30 wholesalers/distributors who may have further distributed the product nationwide.
Termination Date
Jan 05, 2026
Product Description
Ramipril Capsules USP 10 mg, a) 90 count (NDC 68180-591-09), b) 100 count NDC 68180-591-01), and c) 500 count (NDC 68180-591-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by Lupin Limited, Goa, India
Batch or Lot Expiration Information
Lot# a) NDC 68180-591-09; Lots G327086, exp. date 30-Sep-25 GA01065, exp. date 31-Dec-25, b) NDC 68180-591-01 Lots G325033, G324987, exp. date 31-Jul-25, G325110, GA00956, GA01066, GA01126, exp. date 31-Dec-25, GA03299, GA03288, GA03287, exp. date 31-Mar-26 c) NDC 68180-591-02 Lot GA05919, exp. date 31-Jul-26 G327131, exp. date 30-Sep-25
Affected Packages Involved in this Recall
68180-589-09Product
68180-589-10Product
68180-589-01Product
68180-589-02Product
68180-590-09Product
68180-590-10Product
68180-590-01Product
68180-590-02Product
68180-591-09Product
68180-591-10Product
68180-591-02Product
68180-591-01Product
68180-588-01Product
68180-588-02Product
68180-588-09Product
Class II Terminated
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Oct 23, 2024
Nov 27, 2024
112,770 bottles
Recall Profile & Regulatory Data
Event ID
95610
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed to 30 wholesalers/distributors who may have further distributed the product nationwide.
Termination Date
Jan 05, 2026
Product Description
Ramipril Capsules USP 2.5 mg, a) 90 count (NDC 68180-589-09), b) 100 count NDC 68180-589-01), and c) 500 count (NDC 68180-589-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by Lupin Limited, Goa, India
Batch or Lot Expiration Information
Lot# a) NDC 68180-589-09; Lots G326781, exp. date 30-Sep-25, GA04468, exp. date 31-May-25 b) NDC 68180-589-01; Lots G326763, exp. date 30-Sep-25, GA03041, exp. date 31-Mar-26, GA03725, exp. date 30-Apr-26, GA04402, exp. date 31-May-26, c) NDC 68180-589-02; Lots G326782, exp. date 30-Sep-25, GA04462, exp. date 31-May-26
Affected Packages Involved in this Recall
68180-589-09Product
68180-589-10Product
68180-589-01Product
68180-589-02Product
68180-590-09Product
68180-590-10Product
68180-590-01Product
68180-590-02Product
68180-591-09Product
68180-591-10Product
68180-591-02Product
68180-591-01Product
68180-588-01Product
68180-588-02Product
68180-588-09Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
