D-0054-2025 Class II Terminated
FDA drug recall D-0054-2025 was initiated by Lupin Pharmaceuticals Inc. on Oct 23, 2024 and is designated Class II. Reason for recall: CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor The recall status is terminated (terminated Jan 5, 2026). Affected quantity: 357,414 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Nov 27, 2024
- Initiation Date
- Oct 23, 2024
- Termination Date
- Jan 5, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 357,414 bottles
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
Reason for Recall
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Distribution Pattern
Product was distributed to 30 wholesalers/distributors who may have further distributed the product nationwide.
Code Information
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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0054-2025
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026