Pfizer recalls Bleomycin for Injection vials due to glass particulate matter. This may cause serious injury during medical use. Affected vials have specific NDC and lot numbers.
“Pfizer Bleomycin Injection Recall: Glass Particulate Matter Hazard.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32916-pfizer-bleomycin-injection-recall-glass-particulate-matter-hazard. Based on FDA recall #D-0261-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0261-2024%22&limit=1).
The FDA announced on December 21, 2023, that Pfizer is recalling Bleomycin for Injection, USP due to the presence of glass particulate matter. The voluntary Class I recall affects 3,546 vials distributed nationwide in the USA, Netherlands and Libya.
How to tell if you have it
Brand: Pfizer
Product: Bleomycin for Injection, USP
Quantity: 15 units per vial
Packaging: 1 single dose glass fliptop vial
Distributor: Hospira, Inc., Lake Forest, IL 68045
NDC: 61703-332-18
Lot #: BL12206A
Exp date: 06/30/2024
The hazard
The recall is due to the presence of particulate matter, specifically glass, in the product. The FDA classified this as a Class I recall, indicating a situation where there is a reasonable probability that the use of the product will cause serious adverse health consequences or death.
Context
GovInfoNow's records show Pfizer has issued three other recalls since June 28, 2018, including a September 4, 2026 recall for Dopamine HCl Injection regarding sterility risks and a July 29, 2025 recall for Levoxyl tablets due to subpotency. Other recent recalls of similar products include Sun Pharmaceutical's May 12, 2026 DOXOrubin Liposome Injection recall for glass particulate risk and GE Healthcare's March 24, 2026 Omnipaque 300 mg/mL Injection recall for particulate matter hazard.
How to tell if you have this one
Check for vials labeled 'Bleomycin for Injection, USP, 15 units per vial' with NDC 61703-332-18 and lot number BL12206A. These vials were distributed by Hospira and expire June 30, 2024.
Brand
Pfizer
Category
Drug
Based on the official FDA remedy
What to do — step by step
Stop Using Immediately
Discontinue use of the recalled Bleomycin vial if you have it.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Nationwide in the USA, Netherlands and Libya” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 41 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-0261-2024 (December 21, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0261-2024 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.