Hikma Pharmaceuticals recalls Bleomycin injection vials due to mislabeling. This may affect patients using prescription cancer treatment. Contact Hikma for details.
“Hikma Bleomycin Injection Recall: Mislabeling Hazard.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35989-hikma-bleomycin-injection-recall-mislabeling-hazard. Based on FDA recall #D-0771-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0771-2021%22&limit=1).
Hikma Pharmaceuticals USA Inc. recalled Bleomycin for Injection, USP due to mislabeling hazards, according to the FDA on Aug. 5, 2021. The Food and Drug Administration announced the Class III voluntary recall of 1,152 vials distributed nationwide.
How to tell if you have it
Brand: Hikma
Product: Bleomycin for Injection, USP
NDC: 0143-9240-01
Lot code: BL0018
Quantity: 15 units per single dose vial
Manufacturer: Thymoorgan Pharmazie GmbH
Distributor: Hikma USA Inc., Berkeley Heights, NJ
The hazard
The recall addresses mislabeling of the drug product. The FDA classified this as a Class III recall.
Context
GovInfoNow's records show Hikma Pharmaceuticals USA Inc. has 14 other recalls on record since Dec. 17, 2019. Other recent recalls of similar products include Hikma Ramipril Capsules (Aug. 24, 2026), Hikma Alendronate Sodium Oral Solution (April 7, 2026), and Hikma Lorazepam Injection (July 22, 2025). Other recent recalls of similar products include American Regent Levocarnitine Injection (April 16, 2026), Asclemed Lidocaine HCl Injection (June 8, 2026), and Baxter Healthcare Daptomycin Injection (Aug. 6, 2026).
How to tell if you have this one
Check for vials labeled 'Bleomycin for Injection, USP, 15 units per single dose vial, Rx only' with NDC number 0143-9240-01. The vials were manufactured by Thymoorgan Pharmazie in Germany.
Brand
Hikma
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Vial Label
Look for the NDC number 0143-9240-01 on the vial label.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “USA 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 22 months after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
4FDA terminated the recall
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-0771-2021 (August 5, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0771-2021 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.