CLASS II Drug recall · Reported 25 Nov 2015 · FDA Enforcement Report
Fentanyl PF (25 mcg/mL) Single Use Syringe, For IV recalled
US Compounding is recalling Fentanyl PF (25 mcg/mL) Single Use Syringe, For IV, IM or SC injection, distributed nationwide in the US. The recall was initiated on 12 Sep 2015 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-0252-2016
- FDA event ID
- 72179
- Recalling firm
- US Compounding, Conway, AR
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Sep 2015
- FDA classified
- 17 Nov 2015
- Reported
- 25 Nov 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Pain Medication
Timeline
| 12 Sep 2015 | Recall initiated by company | |
| 17 Nov 2015 | Classified by FDA | +66 days |
| 25 Nov 2015 | 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 Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on 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
Fentanyl PF 50 mL (25 mcg/mL), 10 mL Single Use Syringe, For IV, IM or SC injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-0002-50
Where it was distributed
Nationwide
Questions about this recall
Is Fentanyl PF (25 mcg/mL) Single Use Syringe, For IV, IM or SC injection recalled?
Yes. US Compounding recalled Fentanyl PF (25 mcg/mL) Single Use Syringe, For IV, IM or SC injection on 12 Sep 2015. The recall is Class II and its status is Terminated. Recall number D-0252-2016.
Why was it recalled?
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Which lots are affected?
Lot Numbers: 20150604@20 BUD: 10/3/2015; 20152306@20 BUD: 12/20/2015; 20152403@28 BUD: 9/20/2015
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 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.
More recalls from US Compounding
All 65| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Succinylcholine Chloride PF Inj recalled by US Compounding | US Compounding | Other | Nationwide |
| Drug | CLASS III | Neostigmine Methylsulfate PF Inj recalled by US Compounding | US Compounding | Labeling Errors | Nationwide |
| Drug | CLASS II | Ephedrine Sulfate, 50 mg/ Single Use Syringe recalled by US Compounding | US Compounding | Sterility | Nationwide |
| Drug | CLASS II | LET Gel 4% (Lidocaine HCl 4% + EPINEPHrine HCl 05% + recalled | US Compounding | Other | Nationwide |
| Drug | CLASS I | Docusate Oral 10 mg/mL Oral Syringe recalled by US Compounding | US Compounding | Sterility | TX |