Recalls / Class II
Class IID-0054-2025
Product
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
- 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 68180-591-09; 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
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
- 357,414 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-0054-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.