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Lower risk Drug recall · FDA · Published November 22, 2023

Lupin Penicillamine Tablets 250mg Recall: Failed Dissolution Specifications

Lupin Pharmaceuticals recalls 250mg penicillamine tablets (Rx only) due to failed dissolution specifications. This may affect medication effectiveness. Contact for return instructions.

🇺🇸 FDA recall #D-0148-2024DrugLupin Pharmaceuticals ›
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Recalling firmLupin Pharmaceuticals Inc.Harborplace Tower, 111 S Calvert St Fl 21st · Baltimore, MD 21202-6174
✎ GovInfoNow plain-language explainer

What happened, in plain English

Lup: Pharmaceuticals is recalling penicillamine tablets (250mg, 100-count) that failed dissolution tests. This could mean the medication doesn't work properly, so affected users should stop using them and contact the company. Read more at govinfonow.com/recall/32936-lupin-penicillamine-tablets-250mg-recall-failed-dissolution-specifications.

Source Summary by GovInfoNow · govinfonow.com/recall/32936-lupin-penicillamine-tablets-250mg-recall-failed-dissolution-specifications · Updated August 17, 2026 · FDA enforcement record: FDA #D-0148-2024

Cite this page

“Lupin Penicillamine Tablets 250mg Recall: Failed Dissolution Specifications.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32936-lupin-penicillamine-tablets-250mg-recall-failed-dissolution-specifications. Based on FDA recall #D-0148-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0148-2024%22&limit=1).

Why it’s dangerous

The tablets failed dissolution specifications, meaning they may not dissolve properly in the body. This could lead to incorrect medication levels, but the recall does not mention serious injury risks.

Who’s affected

Prescription users of penicillamine tablets (250mg, 100-count) who bought them from pharmacies or hospitals. Patients with specific medical conditions requiring this medication are most at risk.

How to tell if you have this one

Look for penicillamine tablets labeled 250mg, 100-count, Rx only, with NDC# 70748-153-01 and lot number M200498. They were manufactured by Lupin Limited in India and distributed in the U.S. by Lupin Pharmaceuticals, Inc.

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

What to do — step by step

  1. Stop Using Now

    Discard the recalled penicillamine tablets immediately as they may not work properly.

How this recall unfolded

Recall timeline

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

1. Firm started the recall: Nov 22, 202312. FDA classified it Class II: Dec 13, 202323. Published in FDA’s Enforcement Report: Dec 20, 202334. FDA terminated the recall: Jul 8, 2024420232024
  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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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-0148-2024 (November 22, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0148-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 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