Why it was recalled
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
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
Lot numbers, UPCs & expiration codes
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
Where it was sold
Product was distributed to 30 wholesalers/distributors who may have further distributed the product nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0054-2025
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 23, 2024
- FDA report date
- Nov 27, 2024
- Quantity
- 357,414 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0054-2025, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 95610
- Address
- Harborplace Tower
- Address (line 2)
- 111 S Calvert St Fl 21st
- 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
- Postal code
- 21202-6174
- Report date
- Nov 27, 2024
- Product type
- Drugs
- Recall number
- D-0054-2025
- Classification
- Class II
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 357,414 bottles
- Termination date
- Jan 5, 2026
- Reason for recall
- CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Product was distributed to 30 wholesalers/distributors who may have further distributed the product nationwide.
- Recall initiation date
- Oct 23, 2024
- Initial firm notification
- Letter
- Center classification date
- Nov 19, 2024