D-0542-2025 Class II Terminated
FDA drug recall D-0542-2025 was initiated by Lupin Pharmaceuticals Inc. on Jul 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 Jul 30, 2026). Affected quantity: 7668 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 6, 2025
- Initiation Date
- Jul 2, 2025
- Termination Date
- Jul 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0542-2025
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026