Amlodipine and Benazepril HCl Capsules USP 2 — Class II drug recall D-0542-2025

Terminated recall by Lupin Pharmaceuticals Inc., reported 2025-08-06, distributed nationwide. Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan

Recall number	`D-0542-2025`
Product type	Drug
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Lupin Pharmaceuticals Inc., Naples, FL, United States
Recall initiated	2025-07-02
Classified	2025-07-28
Reported by FDA	2025-08-06
Terminated	2026-07-30
Distributed	Nationwide (US)
Quantity	7,668 bottles
Reason classes	labeling
NDC	`68180-0459`, `68180-0459-01`, `68180-0459-02`, `68180-0459-03`, `68180-0463`, `68180-0463-01`, `68180-0463-02`, `68180-0463-03`, `68180-0472`, `68180-0472-01`, `68180-0472-02`, `68180-0472-03`, `68180-0473`, `68180-0473-01`, `68180-0473-02`, `68180-0473-03`, `68180-0755`, `68180-0755-01`, `68180-0755-02`, `68180-0755-03`, `68180-0756`, `68180-0756-01`, `68180-0756-02`, `68180-0756-03`, `68180-0757` and 15 more
Lot numbers	`GB01616`
Expiration dates	`2027-02-28`

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 for recall

Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0542-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.