Recalls / Class II
Class IID-0052-2025
Product
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
- Brand name
- Ramipril
- Generic name
- Ramipril
- Active ingredient
- Ramipril
- Route
- Oral
- NDCs
- 68180-588, 68180-589, 68180-590, 68180-591
- FDA application
- ANDA077626
- Affected lot / code info
- 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
Why it was recalled
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Harborplace Tower, 111 S Calvert St Fl 21st, Baltimore, Maryland 21202-6174
Distribution
- Quantity
- 112,770 bottles
- Distribution pattern
- Product was distributed to 30 wholesalers/distributors who may have further distributed the product nationwide.
Timeline
- Recall initiated
- 2024-10-23
- FDA classified
- 2024-11-19
- Posted by FDA
- 2024-11-27
- Terminated
- 2026-01-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0052-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.