Pfizer Recalls Hydromorphone HCl Injection Due to Sterility Risk
Pfizer recalls specific lots of Hydromorphone HCl Injection due to lack of sterility assurance. Check your vials for lot number 760853A.
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Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.
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What happened, in plain English
Pfizer Inc. is recalling Hydromorphone HCl Injection, USP, 2 mg/mL, 1mL Single-use vials because they may not be sterile. The issue stems from a damaged sterilizing filter used for nitrogen during manufacturing. This affects 115,370 vials distributed in the United States and Singapore. Read more at govinfonow.com/recall/41353-pfizer-recalls-hydromorphone-hcl-injection-due-to-sterility-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/41353-pfizer-recalls-hydromorphone-hcl-injection-due-to-sterility-risk · Updated October 11, 2026 · FDA enforcement record: FDA #D-1167-2017
Cite this page
“Pfizer Recalls Hydromorphone HCl Injection Due to Sterility Risk.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/41353-pfizer-recalls-hydromorphone-hcl-injection-due-to-sterility-risk. Based on FDA recall #D-1167-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1167-2017%22&limit=1).
Why it’s dangerous
The lack of sterility assurance means the injection could contain harmful bacteria or contaminants. Using a non-sterile injectable medication can lead to serious infections or other severe health complications when introduced directly into the body.
Who’s affected
Patients who have been prescribed or received Hydromorphone HCl Injection from Pfizer/Hospira between distribution dates prior to August 22, 2017. Healthcare providers and pharmacies holding this specific stock are also affected.
How to tell if you have this one
Look for single-use vials packaged in cartons of 25. The product is Hydromorphone HCl Injection, USP, 2 mg/mL, 1mL. Check the NDC numbers: 0409-3365-11 (carton) and 0409-3365-01 (vial). The specific lot number to check is 760853A.
- Brand
Pfizer / 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
United States Nationwide (including Puerto Rico) and Singapore
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-1167-2017 | HYDROmorphone HCl Injection, USP, 2 mg/mL, 1mL Single-use vial, packaged in cartons of 25 vials, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3365-11 (carton) and 0409-3365-01(vial); Lot: 760853A | 115,370 vials | 0409-2552-11, 0409-2552-01, 0409-3356-11, 0409-3356-01, 0409-2540-11, 0409-2540-01, 0409-3365-11, 0409-3365-01, 0409-3365-10, 0409-1283-03, 0409-1283-31, 0409-1312-03, 0409-1312-30, 0409-1304-03, 0409-1304-31 |
| D-1168-2017 | Levophed (norepinephrine bitartrate) injection, USP, 4 mg/4 mL (1mg/mL), 4mL Fill in 5 mL Single dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3375-04; Lot #: 753003A, Exp 9/18; 762153A, 760803A, 761053A , Exp 10/18 | 98,050 vials | 0409-3375-14, 0409-3375-04, 0409-1443-14, 0409-1443-04 |
What to do — step by step
Stop using the product
Do not use any vials matching the recalled lot number due to sterility risks.
Contact your provider
Reach out to your healthcare provider or pharmacist for guidance on replacement or disposal.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “United States Nationwide (including Puerto Rico) and Singapore” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 5.5 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.
Questions people ask
Where was this product sold?
The product was distributed nationwide in the United States (including Puerto Rico) and Singapore.
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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-1167-2017 (August 22, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1167-2017 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 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.