D-0052-2025 Class II Terminated
FDA drug recall D-0052-2025 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: 112,770 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
- 112,770 bottles
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
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 68180-589-09; 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0052-2025
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026