D-0542-2025 Class II Terminated
FDA drug recall D-0542-2025 was initiated by Lupin Pharmaceuticals Inc. on July 2, 2025 and is designated Class II. Reason for recall: Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027 The recall status is terminated (terminated July 30, 2026). Affected quantity: 7668 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- August 6, 2025
- Initiation Date
- July 2, 2025
- Termination Date
- July 30, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7668 bottles
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.
Reason for Recall
Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027
Distribution Pattern
Nationwide in the US
Code Information
Lot GB01616, expiration 2/28/2027