CLASS I Drug recall · Reported 25 Dec 2013 · FDA Enforcement Report
0.75% Bupivacaine HCl Injection, USP, 7.5 mg/mL recalled by Hospira
Hospira is recalling 0.75% Bupivacaine HCl Injection, USP, 7.5 mg/mL, Single-dose, Hospira Inc., Lake Forest, distributed nationwide in the US. The recall was initiated on 12 Jul 2013 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-381-2014
- FDA event ID
- 66260
- Recalling firm
- Hospira, Lake Forest, IL
- Manufacturer
- Hospira, Inc.
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 12 Jul 2013
- FDA classified
- 18 Dec 2013
- Reported
- 25 Dec 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 12 Jul 2013 | Recall initiated by company | |
| 18 Dec 2013 | Classified by FDA | +159 days |
| 25 Dec 2013 | Published in enforcement report | +7 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: visible free floating and partially embedded particulate matter in the glass vials.
Product as listed by the FDA
0.75% Bupivacaine HCl Injection, USP, 7.5 mg/mL, 30 mL, Single-dose, Hospira Inc., Lake Forest, IL 60045, NDC 0409-1165-02
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials.
Which lots are affected?
Lot # 23-338-DK, Exp. 11/14
Where was it sold?
Nationwide
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.
Other products in this recall event
1 other product · FDA event 66260This product is part of a recall event; the main page for the event is 0.25% Bupivacaine HCl Injection, USP, 2.5 mg/mL recalled by Hospira.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | 0.25% Bupivacaine HCl Injection, USP, 2.5 mg/mL recalled by HospiraBupivacaine Hydrochloride | Hospira | Particulate Matter | Nationwide |
More recalls from Hospira
All 225| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Infant 25% Dextrose Injection recalled by HospiraDextrose | Hospira | Particulate Matter | Nationwide |
| Device | CLASS II | Minibore Extension Set with Spin Lock Collar, Non-DEHP, Latex-Free recalled | Hospira | Other | Nationwide |
| Drug | CLASS III | 5% Lidocaine HCL and 7.5% Dextrose Injection, USP Single-dose ampule recalled | Hospira | Potency & Assay | PR |
| Drug | CLASS II | Fentanyl Citrate Injection, USP, 100 mcg Fentanyl recalled by Hospira | Hospira | Sterility | Nationwide |
| Device | CLASS II | LifeCare PCA 3, PCA recalled by Hospira | Hospira | Device Malfunction | Nationwide |
Other Bupivacaine recalls
All 49| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection recalledBupivacaine Hydrochloride | Huons | Sterility | Nationwide |
| Drug | CLASS II | BUPIVAcaine HCL Sterile injection recalled by Tailstorm Health | Tailstorm Health | Sterility | Nationwide |
| Drug | CLASS II | Sensorcaine (Bupivacaine HCl and Epinephrine Injection recalledSensorcaine | Fresenius Kabi USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection recalledSensorcaine | Fresenius Kabi USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Sensorcaine (Bupivacaine HCl and Epinephrine Injection recalledSensorcaine | Fresenius Kabi USA | Potency & Assay | Nationwide |