CLASS II Drug recall · Reported 28 Feb 2018 · FDA Enforcement Report
HYDROmorphone HCl in Sodium Chloride 0.9% in all doses recalled
Pharmedium Services is recalling HYDROmorphone HCl in Sodium Chloride 0.9% in all doses, all strengths, and all packaging, distributed nationwide in the US. The recall was initiated on 27 Dec 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-0428-2018
- FDA event ID
- 78828
- Recalling firm
- Pharmedium Services, Lake Forest, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Dec 2017
- FDA classified
- 20 Feb 2018
- Reported
- 28 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Sterility
- Drug class
- Pain Medication
Timeline
| 27 Dec 2017 | Recall initiated by company | |
| 20 Feb 2018 | Classified by FDA | +55 days |
| 28 Feb 2018 | Published in enforcement report | +8 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.
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 in Sodium Chloride 0.9% in all doses, all strengths, and all packaging.
Where it was distributed
U.S.A. Nationwide
Questions about this recall
Why was it recalled?
Lack of sterility assurance.
Which lots are affected?
All lots remaining within expiry.
Where was it sold?
U.S.A. Nationwide
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
41 other products · FDA event 78828This product is part of a recall event; the main page for the event is Glycopyrrolate in all strengths, all doses, and all packaging recalled.
More recalls from Pharmedium Services
All 291| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | rocuronium Bromide, 10 mg per mL, 50 mg per BD Syringe recalled | PharMEDium Services | Sterility | Nationwide |
| Drug | CLASS II | ePHEDrine Sulfate, 5 mg per mL, 25 mg recalled by PharMEDium Services | PharMEDium Services | Sterility | Nationwide |
| Drug | CLASS II | fentaNYL Citrate 10 mcg per mL, 2,500 mcg per in a LifeCare recalled | PharMEDium Services | Sterility | Nationwide |
| Drug | CLASS II | nICARdipine HCl (0.1 mg/mL) 1 mg recalled by PharMEDium Services | PharMEDium Services | Sterility | Nationwide |
| Drug | CLASS II | rocuronium Bromide 10 mg per mL 50 mg per BD Syringe recalled | PharMEDium Services | Sterility | 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 |