Stop using now Drug recall · FDA · Published July 30, 2021

Custopharm FLUDARABINE PHOSPHATE INJECTION Recall: Risk of Contamination

Custopharm recalls 50mg FLUDARABINE PHOS: manufacturing had microbial issues. Stop using if you have this injection. Details: NDC 24201-237-01, Lot 31327913C, Exp 10/2022.

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

🇺🇸 FDA recall #D-0765-2021Drug Custopharm ›

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Lack of Assurance of Sterility: the manufacturing firm had microbial recoveries during environmental monitoring in aseptic areas of manufacturing.

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Contact the company

Recalling firmCustopharm, Inc.2325 Camino Vida Roble · Carlsbad, CA 92011-1567

✎ GovInfoNow plain-language explainer

Custopharm is recalling FLUDARABINE PHOSPHATE injections due to potential contamination from microbial growth during manufacturing. This could lead to serious infections if used improperly. Read more at govinfonow.com/recall/35997-custopharm-fludarabine-phosphate-injection-recall-risk-of-contamination.

Source Summary by GovInfoNow · govinfonow.com/recall/35997-custopharm-fludarabine-phosphate-injection-recall-risk-of-contamination · Updated August 18, 2026 · FDA enforcement record: FDA #D-0765-2021

Cite this page

“Custopharm FLUDARABINE PHOSPHATE INJECTION Recall: Risk of Contamination.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35997-custopharm-fludarabine-phosphate-injection-recall-risk-of-contamination. Based on FDA recall #D-0765-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0765-2021%22&limit=1).

Custopharm, Inc. recalled FLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial on July 30, 2021, due to a lack of assurance of sterility, the FDA said. The recall was initiated voluntarily by the firm.

How to tell if you have it

Brand: Custopharm
Product: FLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial, Single dose vial, Rx Only
Mfd for: Leucadia Pharmaceuticals
NDC: 24201-237-01
Lot#: 31327913C
Exp. Date: 10/2022

The hazard

The manufacturing firm had microbial recoveries during environmental monitoring in aseptic areas of manufacturing, according to the FDA. This created a lack of assurance of sterility for the drug.

Context

GovInfoNow's records show other recent recalls of similar products include Fresenius Kabi Famotidine Injection Recall: Microbial Contamination Risk (2025-11-06), Sunny Pharmtech Cyclophosphamide Injection Recall: Stainless Steel Particulate Risk (2026-07-17), and American Regent Multrys IV injection recall: Particulate matter contamination risk (2026-07-24).

How to tell if you have this one

Check the product label for 'FLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial'. Look for NDC 24201-237-01 and Lot# 31327913C with an expiration date of 10/2022.

Brand
Custopharm
Category
Drug

Based on the official FDA remedy

What to do — step by step

Stop Using Now
Immediately discard the injection if you have the recalled product.

Where it went and when

Where it was distributed

Distributed nationwide.

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

Distributed nationwide.

Recall timeline

FDA terminated this recall 12 months after the firm started it.

Jul 30, 2021Firm started the recall
Aug 23, 2021FDA classified it Class II
Sep 1, 2021Published in FDA’s Enforcement Report
Aug 8, 2022FDA terminated the recall

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

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Link to this recall

<a href="https://govinfonow.com/recall/35997-custopharm-fludarabine-phosphate-injection-recall-risk-of-contamination">Custopharm FLUDARABINE PHOSPHATE INJECTION Recall: Risk of Contamination (GovInfoNow)</a>

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-0765-2021 (July 30, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0765-2021 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.