Pfizer Inc. recalls Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation.
Pfizer recalls 10 mg/mL hydromorphone injection vials that may be empty or cracked, posing a risk of contamination. Affected vials have specific NDC and expiration dates.
Lower-risk recall
Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
Contact the company & request your remedy
What happened, in plain English
Pfizer is recalling high-potency hydromorphone injection vials that may be empty or cracked. This could lead to contamination and potential health risks for patients using the medication. Read more at govinfonow.com/recall/40884-pfizer-recalls-high-potency-hydromorphone-vials-with-possible-empty-or.
Source Summary by GovInfoNow · govinfonow.com/recall/40884-pfizer-recalls-high-potency-hydromorphone-vials-with-possible-empty-or · Updated October 7, 2026 · FDA enforcement record: FDA #D-0597-2018
Cite this page
“Pfizer recalls high-potency hydromorphone vials with possible empty or cracked containers.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40884-pfizer-recalls-high-potency-hydromorphone-vials-with-possible-empty-or. Based on FDA recall #D-0597-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0597-2018%22&limit=1).
Why it’s dangerous
The vials may be empty or cracked, which could allow contamination. This poses a risk of infection or improper medication delivery if the vial is compromised.
Who’s affected
Prescription patients using the recalled hydromorphone vials are affected. Healthcare providers who dispense the medication may also be impacted.
How to tell if you have this one
Check for vials with NDC 0409-2634-01 and expiration date 11/1/2018. The product is a 1 mL single-dose vial of high-potency hydromorphone injection.
- Brand
Pfizer- 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 I- Status
Terminated- Distribution
Nationwide in the USA
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-0596-2018 | Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618. NDC: 0703-0110-01; Lots # 691853F, EXP. 9/1/2018; 700753F, EXP. 10/1/2018. | 53600 vials | 0703-0110-01, 0703-0110-03, 0703-0113-01, 0703-0113-03, 0703-0018-01 |
| D-0597-2018 | Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. Hospira, Inc., Lake forest, IL 60045 USA. NDC: 0409-2634-01; Lot 71330DD EXP. 11/1/2018. | 29, 680 vials | 0409-2634-10, 0409-2634-01, 0409-2634-25, 0409-2634-05, 0409-2634-50 |
What to do — step by step
Check Vial Condition
Inspect the vial for cracks or signs of being empty.
Questions people ask
Why is this product being recalled?
Pfizer recalls these vials due to confirmed customer complaints of empty or cracked containers.
What should I do if I have this product?
The recall record does not specify a remedy, so check the vial for cracks or emptiness and contact your healthcare provider.
Is there a specific expiration date for these vials?
Yes, the vials expire on November 1, 2018.
Contact Pfizer
We’ve drafted a message you can send Pfizer to request your refund or repair — edit it as you like.
Subject: Recall D-0597-2018 — Pfizer Pfizer Hello, I own a Pfizer that is covered by recall D-0597-2018 from Pfizer. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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-0597-2018 (February 7, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0597-2018 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.