Why it was recalled
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Product description
Ramipril Capsules USP 5 mg, a) 90 count (NDC 68180-590-09), b) 100 count NDC 68180-590-01), and c) 500 count (NDC 68180-590-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by Lupin Limited, Goa, India
Lot numbers, UPCs & expiration codes
a) NDC 68180-590-09; Lots G326928, exp. date 30-Sep-25, GA00964, exp. date 31-Dec-25, b) NDC 68180-590-01, Lots G326897, G326929, exp. date 30-Sep-25, GA00854, GA00933, GA00954, exp. date 31-Dec-25, c) NDC 68180-590-02, Lot GA00955, exp. date 31-Dec-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-0053-2025
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 23, 2024
- FDA report date
- Nov 27, 2024
- Quantity
- 146,322 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0053-2025, 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 68180-590-09; Lots G326928, exp. date 30-Sep-25, GA00964, exp. date 31-Dec-25, b) NDC 68180-590-01, Lots G326897, G326929, exp. date 30-Sep-25, GA00854, GA00933, GA00954, exp. date 31-Dec-25, c) NDC 68180-590-02, Lot GA00955, exp. date 31-Dec-25
- Postal code
- 21202-6174
- Report date
- Nov 27, 2024
- Product type
- Drugs
- Recall number
- D-0053-2025
- Classification
- Class II
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 146,322 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 5 mg, a) 90 count (NDC 68180-590-09), b) 100 count NDC 68180-590-01), and c) 500 count (NDC 68180-590-02) 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