CLASS II Drug recall · Reported 19 Oct 2016 · FDA Enforcement Report
Marcaine 0.25% (bupivacaine HCl) injection, USP, 125 mg recalled
Hospira Inc. A Pfizer is recalling Marcaine 0.25% (bupivacaine HCl) injection, USP, 125 mg/ (2.5 mg/mL) Multiple-Dose Vial, distributed nationwide in the US. The recall was initiated on 16 Sep 2016 and the FDA has classified it as Class II.
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-0096-2017
- FDA event ID
- 75156
- Recalling firm
- Hospira Inc. A Pfizer, Lake Forest, IL
- Brand
- Marcaine
- Manufacturer
- Hospira, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Sep 2016
- FDA classified
- 13 Oct 2016
- Reported
- 19 Oct 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Drug class
- Injectable & IV Drugs
Timeline
| 16 Sep 2016 | Recall initiated by company | |
| 13 Oct 2016 | Classified by FDA | +27 days |
| 19 Oct 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
Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Marcaine 0.25% (bupivacaine HCl) injection, USP, 125 mg/50 mL (2.5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1587-50.
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency.
Which lots are affected?
Lot #: 60295DD, Ep 1DEC2017
Where was it sold?
Nationwide and Puerto Rico
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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 75156| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Marcaine 0.5% (bupivacaine HCl) injection, USP, 250 mg recalledMarcaine | Hospira Inc. A Pfizer | Foreign Material | Nationwide |
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 |