FDA Drug recall D-0542-2025
Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naple…
- FDA Drug
- Class II
- terminated
- Published 2025-08-06
On 2025-08-06 the FDA classified a Class II recall of Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naple… by Lupin Pharmaceuticals, citing labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0542-2025 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2025-07-02 |
| Published | 2025-08-06 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Lupin Pharmaceuticals |
| Distribution | US |
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.
Reason
Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027
Identifiers
| ndc | 68180-755-01 |
|---|---|
| ndc | 68180-755-02 |
| ndc | 68180-755-03 |
| ndc | 68180-756-01 |
| ndc | 68180-756-02 |
| ndc | 68180-756-03 |
| ndc | 68180-459-01 |
| ndc | 68180-459-02 |
| ndc | 68180-459-03 |
| ndc | 68180-472-01 |
| ndc | 68180-472-02 |
| ndc | 68180-472-03 |
| ndc | 68180-463-01 |
| ndc | 68180-463-02 |
| ndc | 68180-463-03 |
| ndc | 68180-473-01 |
| ndc | 68180-473-02 |
| ndc | 68180-473-03 |
| ndc | 68180-759-01 |
| ndc | 68180-759-02 |
| ndc | 68180-759-03 |
| ndc | 68180-760-01 |
| ndc | 68180-760-02 |
| ndc | 68180-760-03 |
| ndc | 68180-757-01 |
| ndc | 68180-757-02 |
| ndc | 68180-757-03 |
| ndc | 68180-758-01 |
| ndc | 68180-758-02 |
| ndc | 68180-758-03 |
| code_info | Lot GB01616, expiration 2/28/2027 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0542-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.