CLASS II Drug recall · Reported 20 Jun 2018 · FDA Enforcement Report
HYDROmorphone HCl 0.5 mg per mL recalled by PharMEDium Services
PharMEDium Services is recalling HYDROmorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride Total Volume in syringe, Rx, distributed nationwide in the US. The recall was initiated on 5 Jun 2018 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-0854-2018
- FDA event ID
- 80251
- Recalling firm
- PharMEDium Services, Dayton, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Jun 2018
- FDA classified
- 8 Jun 2018
- Reported
- 20 Jun 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 5 Jun 2018 | Recall initiated by company | |
| 8 Jun 2018 | Classified by FDA | +3 days |
| 20 Jun 2018 | 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
Superpotent and Subpotent
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
HYDROmorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride, 1 mL Total Volume in 3 mL syringe, Rx, PharMEDium Services, LLC, Dayton, NJ
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Superpotent and Subpotent
Which lots are affected?
Lot numbers: 180820005D, exp 6/21/2018; 180990007D, exp 7/8/2018; and 181000020D, exp 7/9/2018
Where was it sold?
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.
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 Per Ml recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Hydromorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride Injection recalled | PharMEDium Services | Potency & Assay | CA, IL |
| Drug | CLASS II | HYDROmorphone HCL 1 mg per mL recalled by SCA Pharmaceuticals | SCA Pharmaceuticals | Sterility | Nationwide |