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Lower risk Drug recall · FDA · Published July 2, 2025

Lupin Amlodipine Benazepril Capsules: Incorrect Expiry Date Risk

Lupin Pharmaceuticals recalls 2.5mg/10mg capsules with wrong expiry date (Feb 2027 instead of Jan 2027). Discard or contact for replacement.

🇺🇸 FDA recall #D-0542-2025DrugLupin ›
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Recalling firmLupin Pharmaceuticals Inc.5801 Pelican Bay Blvd, Suite 500 · Naples, FL 34108-2755
✎ GovInfoNow plain-language explainer

Lupin Pharmaceuticals is recalling amlodipine and benazepril capsules due to incorrect expiry dates. This could lead to medication safety issues if the capsules are used after the wrong expiration date. Read more at govinfonow.com/recall/32003-lupin-amlodipine-benazepril-capsules-incorrect-expiry-date-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/32003-lupin-amlodipine-benazepril-capsules-incorrect-expiry-date-risk · Updated August 18, 2026 · FDA enforcement record: FDA #D-0542-2025

Cite this page

“Lupin Amlodipine Benazepril Capsules: Incorrect Expiry Date Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/32003-lupin-amlodipine-benazepril-capsules-incorrect-expiry-date-risk. Based on FDA recall #D-0542-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0542-2025%22&limit=1).

Lupin Pharmaceuticals Inc. recalled Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100-count bottles nationwide due to labeling errors showing an incorrect expiration date, the FDA said on July 2, 2025.

How to tell if you have it

  • Brand: Lupin
  • Product: Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle
  • NDC: 68180-755-01
  • Lot: GB01616
  • Expiration Date on Label: Feb.2027 (should be Jan.2027)
  • Quantity: 7668 bottles

The hazard

The product was released with the wrong expiry date as Feb.2027 instead of Jan.2027.

Context

GovInfoNow's records show Lupin Pharmaceuticals Inc. has 90 other recalls on record since 2013-01-31. Other recent recalls of similar products include Lupin Clobetasol Cream Recall (2026-08-03), Lupin Glucagon Emergency Kit Recall (2026-06-23), and Lupin prednisolone acetate ophthalmic suspension recall (2026-06-04). Other recent recalls of similar products include OurPharma Fentanyl Injection Recall (2026-09-03), Sandoz Focalin XR 5mg Capsules: Missing Lot/Exp Date Recall (2026-06-01), and Premier Dental Products: Incorrect Expiration Date on Ferric Subsulfate Solution (2026-04-14).

How to tell if you have this one

Check for the lot number GB01616 on the bottle. The product is a 2.5 mg/10 mg amlodipine and benazepril capsule bottle sold by prescription.

  • Brand
    Lupin
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Expiry Date

    Verify the expiration date on the bottle label. If it shows February 2027 instead of January 2027, it is recalled.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide in the US” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 13 months after the firm started it.

1. Firm started the recall: Jul 2, 202512. FDA classified it Class II: Jul 28, 202523. Published in FDA’s Enforcement Report: Aug 6, 202534. FDA terminated the recall: Jul 30, 2026420252026
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Other Lupin recalls

Keep exploring

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0542-2025 (July 2, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0542-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA