Hospira Marcaine 0.25% Injection Recall: Risk of Lower Potency Due to Glass Defect
Hospira recalls Marcaine 0.25% injections with a glass defect that may cause the product to be less potent than labeled. Affected lots were sold in 2017. Consumers should contact Hospira for details.
Lower-risk 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.
Contact the company
What happened, in plain English
Hospira is recalling Marcaine 0.25% (bupivacaine) injections that may have been diluted due to a glass defect. This could lead to less effective pain relief during medical procedures. The product is prescription-only and sold in 50 mL vials. Read more at govinfonow.com/recall/42437-hospira-marcaine-0-25-injection-recall-risk-of-lower-potency.
Source Summary by GovInfoNow · govinfonow.com/recall/42437-hospira-marcaine-0-25-injection-recall-risk-of-lower-potency · Updated October 9, 2026 · FDA enforcement record: FDA #D-0096-2017
Cite this page
“Hospira Marcaine 0.25% Injection Recall: Risk of Lower Potency Due to Glass Defect.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42437-hospira-marcaine-0-25-injection-recall-risk-of-lower-potency. Based on FDA recall #D-0096-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0096-2017%22&limit=1).
Why it’s dangerous
A defect in the glass vial prevented the stopper from sealing properly. This allowed water to enter the vial and dilute the medication, reducing its potency. The product may not provide the intended pain relief during procedures.
Who’s affected
Prescription patients receiving Marcaine 0.25% injections from Hospira. Healthcare providers using the product for medical procedures are most at risk.
How to tell if you have this one
Check for the product name 'Marcaine 0.25% (bupivacaine HCl) injection, USP, 125 mg/50 mL (2.5 mg/mL), 50 mL Multiple-Dose Vial'. The lot number 60295DD was produced in December 2017.
- Brand
Hospira- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide and Puerto Rico- NDC
0409-1559-18, 0409-1559-10, 0409-1559-19, 0409-1559-30, 0409-1560-18, 0409-1560-10, 0409-1560-19, 0409-1560-29, 0409-1582-18, 0409-1582-10, 0409-1582-19, 0409-1582-29, 0409-1587-50, 0409-1610-50, 0409-1746-70, 0409-1746-10, 0409-1746-71, 0409-1746-30, 0409-1749-70, 0409-1749-10, 0409-1749-71, 0409-1749-29, 0409-1752-50, 0409-1755-50, 0409-2510-01, 0409-2510-25, 0409-7535-01, 0409-7535-25, 0409-1250-01, 0409-1250-25, 0409-5010-01, 0409-5010-25, 0409-1530-01, 0409-1530-25, 0409-0525-01, 0409-0525-25, 0409-7510-01, 0409-7510-25, 0409-2253-01, 0409-2253-25
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0096-2017 | 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.; Lot #: 60295DD, Ep 1DEC2017 | 15 vials |
| D-0097-2017 | Marcaine 0.5% (bupivacaine HCl) injection, USP, 250 mg/50 mL (5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1610-50.; Lot #: 59310DD, Exp 1NOV2017 | 4768 vials |
What to do — step by step
Check Product Details
Look for the lot number 60295DD on the vial label, which was produced in December 2017.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.9 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
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-0096-2017 (September 16, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0096-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 9, 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.