CLASS I ONGOING Drug recall · Reported 28 Dec 2016 · FDA Enforcement Report
Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) recalled
Hospira Inc. A Pfizer is recalling Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, distributed nationwide in the US. The recall was initiated on 4 Aug 2016 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-0218-2017
- FDA event ID
- 74925
- Recalling firm
- Hospira Inc. A Pfizer, Lake Forest, IL
- Manufacturer
- Hospira, Inc.
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 4 Aug 2016
- FDA classified
- 22 Dec 2016
- Reported
- 28 Dec 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 4 Aug 2016 | Recall initiated by company | |
| 22 Dec 2016 | Classified by FDA | +140 days |
| 28 Dec 2016 | 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: Confirmed customer report for the presence of particulate matter within a single vial.
Product as listed by the FDA
Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Single-dose Preservative-Free vials, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1159-02
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial.
Which lots are affected?
Lot # 59064DK, Exp. 11/17
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.
More recalls from Hospira Inc. A Pfizer
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Labetalol Hydrochloride Injection, USP, 100 mg recalledLabetalol Hydrochloride | Hospira Inc. A Pfizer | Foreign Material | Nationwide |
| Drug | CLASS III | Argatroban Injection, 250 mg/ (100 mg/mL) Single-use vial recalled | Hospira Inc. A Pfizer | Potency & Assay | Nationwide |
| Drug | CLASS II | Levophed norepinephrine bitartrate, injection, USP, 4 mg / (1 mg/mL) recalledLevophed | Hospira Inc. A Pfizer | Packaging Defects | Nationwide |
| Drug | CLASS I | Vancomycin Hydrochloride for Injection, USP, Pharmacy recalled | Hospira Inc. A Pfizer | Particulate Matter | Nationwide |
| Drug | CLASS II | METRONIDazole Injection, USP 500 mg (5 mg/mL) recalled | Hospira Inc. A Pfizer | Sterility | Nationwide |
Other Bupivacaine recalls
All 54| 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 |