Recalls / Class II
Class IID-0542-2025
Product
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.
- Brand name
- Amlodipine Besylate And Benazepril Hydrochloride
- Generic name
- Amlodipine Besylate And Benazepril Hydrochloride
- Active ingredients
- Amlodipine Besylate, Benazepril Hydrochloride
- Route
- Oral
- NDCs
- 68180-459, 68180-755, 68180-756, 68180-472, 68180-463, 68180-473, 68180-759, 68180-760, 68180-757, 68180-758
- FDA application
- ANDA078466
- Affected lot / code info
- Lot GB01616, expiration 2/28/2027
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
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 5801 Pelican Bay Blvd, Suite 500, Naples, Florida 34108-2755
Distribution
- Quantity
- 7668 bottles
- Distribution pattern
- Nationwide in the US
Timeline
- Recall initiated
- 2025-07-02
- FDA classified
- 2025-07-28
- Posted by FDA
- 2025-08-06
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0542-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.