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
Is HYDROmorphone HCl Injection, USP, 2 mg/mL Single-use vial recalled?
Yes. Pfizer recalled HYDROmorphone HCl Injection, USP, 2 mg/mL Single-use vial on 22 Aug 2017. The recall is Class II and its status is Terminated. Recall number D-1167-2017.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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| Drug | CLASS II | Bicillin L-A (penicillin G benzathine injectable recalled by PfizerBicillin L-a | Pfizer | Particulate Matter | Nationwide |
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Other Hydromorphone recalls
All 18| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Hydromorphone Hydrochloride Injection, USP, 50mg/ (10 mg/mL) recalled | Akorn | Sterility | Nationwide |
| Drug | CLASS II | HYDROmorphone HCl Injection, USP, 10 mg/ 2 mg/mL) syringes recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |
| Drug | CLASS II | HYDROmorphone HCl Injection, USP, 50 mg/ (1 mg/mL) syringes recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |
| Drug | CLASS II | HYDROmorphone HCl Injection, USP 30 mg/ (1 mg/mL) syringe recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |
| Drug | CLASS II | HYDROmorphone HCl Injection, USP, 6 mg/ 2 mg/mL) syringes recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |