Hospira Recalls Bupivacaine Hydrochloride Due to Particulate Matter
Hospira recalls 143,250 vials of Bupivacaine Hydrochloride Injection due to confirmed particulate matter. Check lot #59064DK.
Stop using this now
Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial.
Contact the company
What happened, in plain English
Hospira Inc., a Pfizer company, is recalling one lot of Bupivacaine Hydrochloride Inj., USP because customer reports confirmed the presence of particulate matter inside a single vial. This recall affects 143,250 vials distributed nationwide. The record does not specify the current remedy or return instructions for this specific recall. Read more at govinfonow.com/recall/42497-hospira-recalls-bupivacaine-hydrochloride-due-to-particulate-matter.
Source Summary by GovInfoNow · govinfonow.com/recall/42497-hospira-recalls-bupivacaine-hydrochloride-due-to-particulate-matter · Updated October 11, 2026 · FDA enforcement record: FDA #D-0218-2017
Cite this page
“Hospira Recalls Bupivacaine Hydrochloride Due to Particulate Matter.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/42497-hospira-recalls-bupivacaine-hydrochloride-due-to-particulate-matter. Based on FDA recall #D-0218-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0218-2017%22&limit=1).
Why it’s dangerous
The presence of particulate matter in an injectable drug poses a risk of embolism, infection, or tissue damage when injected into the body. Class I recalls indicate that use of the product could cause serious adverse health consequences or death.
Who’s affected
Patients who have received or may receive Bupivacaine Hydrochloride Injection from the recalled lot, particularly those using it for anesthesia or pain management. Healthcare providers and pharmacies holding this inventory are also affected.
How to tell if you have this one
Look for Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25% in 30 mL Single-dose Preservative-Free vials. Check for NDC 0409-1159-02, Lot # 59064DK, and an expiration date of 11/17.
- Brand
Hospira- Category
Drug
What to do — step by step
Stop using the product
Do not administer or use any vials matching the recalled lot number due to the risk of particulate matter.
Check inventory details
Verify if your stock matches NDC 0409-1159-02, Lot # 59064DK, Exp. 11/17.
Contact manufacturer
Reach out to Hospira Inc. for further instructions on disposal or return, as specific remedy details are not provided in this record.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 5 months after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
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-0218-2017 (August 4, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0218-2017 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 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.