CLASS II Drug recall · Reported 27 Sep 2017 · FDA Enforcement Report
HYDROmorphone HCl Injection, USP, 2 mg/mL Single-use vial recalled
Pfizer is recalling HYDROmorphone HCl Injection, USP, 2 mg/mL Single-use vial, distributed nationwide in the US. The recall was initiated on 22 Aug 2017 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1167-2017
- FDA event ID
- 77956
- Recalling firm
- Pfizer, New York, NY
- Manufacturer
- Hospira, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Aug 2017
- FDA classified
- 15 Sep 2017
- Reported
- 27 Sep 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Pain Medication
Timeline
| 22 Aug 2017 | Recall initiated by company | |
| 15 Sep 2017 | Classified by FDA | +24 days |
| 27 Sep 2017 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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)
Where it was distributed
United States Nationwide (including Puerto Rico) and Singapore
Questions about this recall
Why was it recalled?
Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.
Which lots are affected?
Lot: 760853A
Where was it sold?
United States Nationwide (including Puerto Rico) and Singapore
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 77956| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Levophed (norepinephrine bitartrate) injection, USP, 4 mg recalledLevophed | Pfizer | Sterility | Nationwide |
More recalls from Pfizer
All 127| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Dopamine HCl Inj., USP, 200 mg/ (40 mg/mL) Single-dose recalledDopamine Hydrochloride | Pfizer | Sterility | Nationwide |
| Drug | CLASS II | Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq recalledSodium Bicarbonate | Pfizer | Sterility | Nationwide |
| Drug | CLASS II | Vial Label: Epinephrine Injection, USP, 1mg/ (0.1 mg/mL) recalled | Pfizer | Sterility | Nationwide |
| Drug | CLASS II | Levoxyl (levothyroxine sodium tablets, USP), 50 mcg recalled by PfizerLevoxyl | Pfizer | Potency & Assay | NY |
| Drug | CLASS II | Bicillin L-A (penicillin G benzathine injectable recalled by PfizerBicillin L-a | Pfizer | Particulate Matter | Nationwide |
Other Hydromorphone recalls
All 155| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | HYDROmorphone Hydrochloride 50mg/ (1mg/mL) recalled by OurPharma | OurPharma | Potency & Assay | Nationwide |
| Drug | CLASS II | HYDROmorphone HCl 30 mg/ in 0.9% Sodium Chloride Injection recalled | SCA Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | HYDROmorphone HCl 6 mg/ in 0.9% Sodium Chloride Injection recalled | SCA Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | HYDROmorphone HCl 25 mg/ in 0.9% Sodium Chloride Injection recalled | SCA Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | HYDROmorphone HCl 20 mg/ in 0.9% Sodium Chloride Injection recalled | SCA Pharmaceuticals | Sterility | Nationwide |