Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027
Product description
Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL, 34108, United States, Manufactured by: Lupin Limited, Goa 103 722, INDIA, NDC 68180-755-01.
Lot numbers, UPCs & expiration codes
Lot GB01616, expiration 2/28/2027
Where it was sold
Nationwide in the US
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-0542-2025
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 2, 2025
- FDA report date
- Aug 6, 2025
- Quantity
- 7668 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0542-2025, exactly as published.
Show all FDA fields
- City
- Naples
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 97182
- Address
- 5801 Pelican Bay Blvd
- Address (line 2)
- Suite 500
- Code information
- Lot GB01616, expiration 2/28/2027
- Postal code
- 34108-2755
- Report date
- Aug 6, 2025
- Product type
- Drugs
- Recall number
- D-0542-2025
- Classification
- Class II
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 7668 bottles
- Termination date
- Jul 30, 2026
- Reason for recall
- Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL, 34108, United States, Manufactured by: Lupin Limited, Goa 103 722, INDIA, NDC 68180-755-01.
- Distribution pattern
- Nationwide in the US
- Recall initiation date
- Jul 2, 2025
- Initial firm notification
- Letter
- Center classification date
- Jul 28, 2025