Hospra Hydromorphone Injection Recall: Silicone Oil Particulate Risk
Hospra recalls 50 mL Hydromorphone injection vials due to silicone oil particles. This may cause serious injury if injected. Check NDC 0703-0018-01 and lot 560053F.
Stop using this now
Presence of Particulate Matter: Silicone oil
Contact the company
What happened, in plain English
Hospra is recalling hydromorphone injection vials that may contain silicone oil particles. Using these vials could cause serious injury if the particles enter the bloodstream during injection. Read more at govinfonow.com/recall/41424-hospra-hydromorphone-injection-recall-silicone-oil-particulate-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/41424-hospra-hydromorphone-injection-recall-silicone-oil-particulate-risk · Updated October 7, 2026 · FDA enforcement record: FDA #D-1080-2017
Cite this page
“Hospra Hydromorphone Injection Recall: Silicone Oil Particulate Risk.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/41424-hospra-hydromorphone-injection-recall-silicone-oil-particulate-risk. Based on FDA recall #D-1080-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1080-2017%22&limit=1).
Why it’s dangerous
Silicone oil particles can enter the bloodstream during injection, potentially causing serious injury or death. This risk occurs when the vials are used as intended for medical administration.
Who’s affected
Healthcare professionals using the recalled vials for medical injections. Patients receiving injections from these vials are at risk of serious injury.
How to tell if you have this one
Check for NDC code 0703-0018-01 and lot number 560053F on the vial. The vials were manufactured for Teva Parenteral Medicines, Inc. in Irvine, California.
- Brand
Hospra- Category
Drug
All 3 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 in the USA
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-1080-2017 | Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Single Dose Vial. Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618 USA. NDC: 0703-0018-01; Lot #: 560053F, Exp. 01AUG2017 | 14,300 vials | 0703-0110-01, 0703-0110-03, 0703-0113-01, 0703-0113-03, 0703-0018-01 |
| D-1081-2017 | Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Single Dose Vial per Carton, 100 vials per case. Hospira, Inc., Lake Forest, IL 60045 USA, NDC: 0409-2634-50; Lot #: 56260DD, Exp. 01AUG2017 | 9,009 vials | 0409-2634-10, 0409-2634-01, 0409-2634-25, 0409-2634-05, 0409-2634-50 |
| D-1082-2017 | Hydromorphone Hydrochloride Injection, USP, 50 mg/5 mL (10 mg/mL), 5 mL Single Dose Vial.(10 vials per carton NDC 0703-0113-01) and 180 vials per case (NDC 0703-0113-03) Mfd By: Hospira, Inc., Lake Forest, IL 60045 USA, Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618 USA.; Lot #: 560103F, Exp. 01AUG2017 | 56,340 vials | 0703-0110-01, 0703-0110-03, 0703-0113-01, 0703-0113-03, 0703-0018-01 |
What to do — step by step
Stop Using Now
Immediately discard the vial if it contains silicone oil particles, as using it could cause serious injury.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 9 months 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.
Questions people ask
When was this product manufactured?
The vials were manufactured with lot number 560053F, expiring August 2017.
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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-1080-2017 (July 26, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1080-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 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.