FDA Recall D-0542-2025

Lupin Pharmaceuticals Inc. · Naples, FL

Class II Ongoing 316 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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.

Lot / code: Lot GB01616, expiration 2/28/2027

Quantity: 7668 bottles

Reason for recall

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

Recall record

Recall number: D-0542-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the US
Recall initiated: 2025-07-02
Classified by FDA Center: 2025-07-28
FDA published: 2025-08-06
Recalling firm: Lupin Pharmaceuticals Inc.
Firm location: Naples, FL

Drug identification

Brand name(s): AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
Generic name(s): AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
Manufacturer(s): Lupin Pharmaceuticals, Inc.
NDC(s): 68180-459, 68180-755, 68180-756, 68180-472, 68180-463, 68180-473, 68180-759, 68180-760, 68180-757, 68180-758
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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