Hospira Recalls Marcaine Injection Vials Due to Visible Metal Particles
Hospira is recalling 85,680 vials of Marcaine (bupivacaine HCl) injection because a customer complaint confirmed the presence of visible metal particles and discolored solution.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA has classified this recall as Class I, which indicates a reasonable probability that use of or exposure to the violative product will cause serious adverse health consequences or death.
Plain-English summary
Hospira Inc. is recalling 85,680 vials of Marcaine (bupivacaine HCl) injection, USP, 0.25%, Preservative-Free, 10 mL (25 mg) Single-dose Vial. The recall is limited to Lot # 34-440-DD, which has an expiration date of 10/15. The product is distributed nationwide.
The recall was initiated following a confirmed customer complaint regarding the presence of particulate matter. The complaint described a discolored solution with visible metal particles embedded in the glass vial and visible in the solution. The FDA has classified this recall as Class I.
Healthcare providers and patients should stop using the affected vials immediately. Consumers should check their medication for the specific lot number and expiration date listed above. If the product matches the recalled lot, it should be returned to the pharmacy or healthcare provider for disposal or replacement.
The recalled product
- Product
- MARCAINE (BUPIVACAINE HYDROCHLORIDE)
- Brand
- MARCAINE
- Manufacturer
- Hospira Inc.
- Category
- Drug — Prescription Injection
- Affected units
- 85,680
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 34-440-DD
- Exp 10/15
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · MARCAINE
- SevereHospira Recalls Marcaine Injection Vials Due to Sterility and Potency Defects
FDA (Drugs) · 2016-10-19
- SevereHospira Recalls Marcaine Injection Due to Sterility and Potency Issues
FDA (Drugs) · 2016-10-19
- SevereHospira Recalls Marcaine Injection Vials Due to Visible Metal Particles
FDA (Drugs) · 2014-10-08
- SevereHospira Recalls Marcaine Injection Vials Due to Metal Particulate Matter
FDA (Drugs) · 2014-03-26
Same manufacturer · Hospira Inc.
See all →- CriticalHospira Recalls Dextrose Injection Syringes Due to Human Hair Particulate
FDA (Drugs) · 2017-05-31
- ModerateHospira Recalls Minibore Extension Sets Due to Solvent Occlusion
FDA (Devices) · 2017-01-18
- LowHospira Recalls Lidocaine and Dextrose Injection for Stability Failures
FDA (Drugs) · 2016-12-14
- SevereHospira Recalls Fentanyl Citrate Injection Ampules Due to Broken Tips
FDA (Drugs) · 2016-11-30
- HighHospira Symbiq Infusion Pump Recall for White Screen Safety Shutdown
FDA (Devices) · 2016-11-16
Same hazard · particulate matter
See all →- SevereACTHAR Gel Recalled for Presence of Glass and Stopper Particulate Matter
FDA (Drugs) · 2026-09-02
- SevereB. Braun Recalls Lactated Ringer's Injection Due to Particulate Matter
FDA (Drugs) · 2026-09-02
- CriticalAmerican Regent Recalls Papaverine Hydrochloride Injection Due to Particulate Matter
FDA (Drugs) · 2026-08-26
- SevereAmerican Regent Recalls Nitroglycerin Injection Due to Particulate Matter
FDA (Drugs) · 2026-08-26
- SevereAmerican Regent Recalls Cyanocobalamin Injections Due to Particulate Matter
FDA (Drugs) · 2026-08-26