CLASS I ONGOING Drug recall · Reported 31 Jan 2024 · FDA Enforcement Report
Bleomycin for Injection, USP per vial dose glass fliptop vial recalled
Pfizer is recalling Bleomycin for Injection, USP per vial dose glass fliptop vial, distributed nationwide in the US. The recall was initiated on 21 Dec 2023 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0261-2024
- FDA event ID
- 93693
- Recalling firm
- Pfizer, New York, NY
- Brand
- Bleomycin
- Manufacturer
- Hospira, Inc.
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 21 Dec 2023
- FDA classified
- 25 Jan 2024
- Reported
- 31 Jan 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 21 Dec 2023 | Recall initiated by company | |
| 25 Jan 2024 | Classified by FDA | +35 days |
| 31 Jan 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of particulate matter: glass
Product as listed by the FDA
Bleomycin for Injection, USP, 15 units per vial, 1 single dose glass fliptop vial, Rx Only, Distributed by: Hospira, Inc., Lake Forest, IL 68045, NDC 61703-332-18
Where it was distributed
Nationwide in the USA, Netherlands and Libya
Questions about this recall
Why was it recalled?
Presence of particulate matter: glass
Which lots are affected?
Lot #: BL12206A, Exp date 06/30/2024
Where was it sold?
Nationwide in the USA, Netherlands and Libya
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
| Drug | CLASS II | Dopamine HCl Inj., USP, 200 mg/ (40 mg/mL) Single-dose recalledDopamine Hydrochloride | Pfizer | Sterility | Nationwide |
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| Drug | CLASS II | Vial Label: Epinephrine Injection, USP, 1mg/ (0.1 mg/mL) recalled | Pfizer | Sterility | Nationwide |
| Drug | CLASS II | Levoxyl (levothyroxine sodium tablets, USP), 50 mcg recalled by PfizerLevoxyl | Pfizer | Potency & Assay | NY |
| Drug | CLASS II | Bicillin L-A (penicillin G benzathine injectable recalled by PfizerBicillin L-a | Pfizer | Particulate Matter | Nationwide |
Other Bleomycin recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Bleomycin for Injection recalled by Hikma Pharmaceuticals USABleomycin | Hikma Pharmaceuticals USA | Labeling Errors | Nationwide |