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Lower risk Drug recall · FDA · Published June 10, 2022

Lupin Zileuton 600mg Tablets Recall: Failed Dissolution Testing

Lupin Pharmaceuticals recalls 600mg Zileuton Extended-Release Tablets due to failed dissolution testing. Rx-only medication with specific batch numbers and expiration dates. Consumers should contact manufacturer for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-1150-2022DrugLupin Pharmaceuticals ›
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Contact the company

Recalling firmLupin Pharmaceuticals Inc.Harborplace Tower, 111 S Calvert St Fl 21st · Baltimore, MD 21202-6174
✎ GovInfoNow plain-language explainer

Lupin Pharmaceuticals is recalling 600mg Zileuton Extended-Release Tablets that failed dissolution testing during stability studies. This means the medication may not release properly in the body, potentially affecting effectiveness. The recall applies to specific batch numbers and expiration dates. Read more at govinfonow.com/recall/34624-lupin-zileuton-600mg-tablets-recall-failed-dissolution-testing.

Source Summary by GovInfoNow · govinfonow.com/recall/34624-lupin-zileuton-600mg-tablets-recall-failed-dissolution-testing · Updated August 18, 2026 · FDA enforcement record: FDA #D-1150-2022

Cite this page

“Lupin Zileuton 600mg Tablets Recall: Failed Dissolution Testing.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/34624-lupin-zileuton-600mg-tablets-recall-failed-dissolution-testing. Based on FDA recall #D-1150-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1150-2022%22&limit=1).

The FDA announced on June 10, 2022, that Lupin Pharmaceuticals Inc. is recalling Zileuton Extended-Release Tablets due to failed dissolution specifications. The agency classified the recall as Class II.

How to tell if you have it

  • Brand: Lupin Pharmaceuticals
  • Product: Zileuton Extended-Release Tablets, 600 mg, 120-count bottle
  • NDC: 68180-169-16
  • Lots: M100070 (Exp. 06/22), M100239 (Exp. 06/22), M100312 (Exp. 09/22), M100366 (Exp. 10/22)

The hazard

The recall addresses out-of-specification test results observed in dissolution testing during a long-term stability study. The FDA classified the action as Class II.

Context

GovInfoNow's records show Lupin Pharmaceuticals Inc. has 90 other recalls on record since Jan. 31, 2013. Other recent recalls of similar products include Lupin Clobetasol Cream (Aug. 3, 2026), Lupin Glucagon Emergency Kit (June 23, 2026), and Lupin prednisolone acetate ophthalmic suspension (June 4, 2026). Other recent recalls of similar products include Lannett Niacin Extended-release Tablets (May 27, 2026), Sun Pharmaceutical Lisdexamfetamine Capsules (Oct. 28, 2025), and Golden State NIACIN Extended-Release Tablets (May 29, 2026).

How to tell if you have this one

Check for the product name 'Zileuton Extended-Release Tablets, 600 mg, 120-count bottle', Rx only. Look for batch numbers M100070, M100239, M100312, M100366 and expiration dates up to 10/22.

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

What to do — step by step

  1. Check Product Details

    Identify the batch numbers and expiration dates listed in the recall notice to confirm if your product is affected.

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: “Product was distributed to 10 wholesalers/distributors and one mail order account who may have further distributed the product nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 8 months after the firm started it.

1. Firm started the recall: Jun 10, 202212. FDA classified it Class II: Jun 15, 202223. Published in FDA’s Enforcement Report: Jun 22, 202234. FDA terminated the recall: Feb 8, 2023420222023
  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.

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Teva Pharmaceuticals USA, IncPreferred Pharma Recalls Lidocaine Ointment Due to Content Issues
Preferred Pharmaceuticals, Inc.Northstar Rx Recalls Tretinoin Cream Due to Impurities
SUN PHARMACEUTICAL INDUSTRIES INCApothecary Pharma Recalls Tirzepatide Injections Due to Sterility Risk
Apothecary Pharma LLC

Other Lupin Pharmaceuticals recalls

Lupin Pharmaceuticals Inc. recalls Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL
August 3, 2026Lupin Pharmaceuticals Inc. recalls Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg per vial, Diluent for Glucagon, 1 mL
June 23, 2026Lupin Pharmaceuticals Inc. recalls prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile, a) 5 mL (NDC 70748-332-02); b) 10 mL (NDC
June 4, 2026Lupin Pharmaceuticals Inc. recalls Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108,
April 24, 2026Lupin Pharmaceuticals Inc. recalls Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/2' needle, Rx only,
November 13, 2025Lupin Pharmaceuticals Inc. recalls Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals,
November 5, 2025

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-1150-2022 (June 10, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1150-2022 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