Class II
Ongoing
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.
This recall is currently active, issued August 6, 2025. It was issued by Lupin Pharmaceuticals Inc..
- Company
- Lupin Pharmaceuticals Inc.
- Recall Initiated
- July 2, 2025
- Posted
- August 6, 2025
- Recall Number
- D-0542-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 7668 bottles
- Firm Location
- Naples, FL, United States
- Official Source
- View on FDA website ↗
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
Nationwide in the US
Lot / Code Info
Lot GB01616, expiration 2/28/2027
More recalls by Lupin Pharmaceuticals Inc.
Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/2'...
Dec 17, 2025 · Class II
Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Ph...
Dec 17, 2025 · Class II
clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite...
Jul 30, 2025 · Class II
Other recent Class II Drug recalls
Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief, L...
Wizcure Pharmaa Private Limited
· Mar 4, 2026
Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: Av...
Avkare
· Mar 4, 2026
Agebox iKids-Growth (Day Formula) capsules, 60-count bottles, Manufactured Exclusively For: AGEBOX I...
Agebox
· Mar 4, 2026
Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPL...
Leo Pharma Inc
· Mar 4, 2026
Pro Numb Tattoo Numbing Spray, For Sensitive Skin, 4% Lidocaine, [1FL OZ/28.4 ML or 4 oz/120 mL] per...
Pro Numb Tattoo Numbing Spray Llc
· Feb 18, 2026