CLASS II Drug recall · Reported 27 Feb 2019 · FDA Enforcement Report
Ephedrine Sulfate, 50 mg/ Single Use Syringe recalled by US Compounding
US Compounding is recalling Ephedrine Sulfate, 50 mg/ Single Use Syringe, distributed nationwide in the US. The recall was initiated on 29 Jan 2019 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-0508-2019
- FDA event ID
- 82012
- Recalling firm
- US Compounding, Conway, AR
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Jan 2019
- FDA classified
- 15 Feb 2019
- Reported
- 27 Feb 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Compounded Drugs
Timeline
| 29 Jan 2019 | Recall initiated by company | |
| 15 Feb 2019 | Classified by FDA | +17 days |
| 27 Feb 2019 | 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 assurance of sterility.
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
Ephedrine Sulfate, 50 mg/10 mL, 10 mL Single Use Syringe, Rx only, US Compounding Pharmacy 1270 Don's Lane Conway, AR 800-718-3588, Barcode: 62295308407
Where it was distributed
U.S.A. Nationwide
Questions about this recall
Why was it recalled?
Lack of assurance of sterility.
Which lots are affected?
Lot: 20181812@2 BUD: 06/16/2019
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.
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 | LET Gel 4% (Lidocaine HCl 4% + EPINEPHrine HCl 0.05% + recalled | US Compounding | Other | Nationwide |
| Drug | CLASS I | Docusate Oral 10 mg/mL Oral Syringe recalled by US Compounding | US Compounding | Sterility | TX |
| Drug | CLASS II | Fentanyl PF (25 mcg/mL) Single Use Syringe, For IV recalled | US Compounding | Sterility | Nationwide |
Other Ephedrine recalls
All 36| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | ePHEDrine in 0.9% sodium chloride, 50 mg/, (10 mg/mL) Syringe recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |
| Drug | CLASS II | ePHEDrine in 0.9% sodium chloride, 50 mg /, (10 mg/mL) Syringe recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |
| Drug | CLASS II | Ephedrine Sulfate Injection recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Ephedrine Plus (Ephedrine HCl 25mg, Guaifenesin 200mg) tablets recalled | Ultra Seal | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | ePHEDrine Sulfate, 50 mg/ in 0.9% Sodium Chloride Injection recalled | SCA Pharmaceuticals | Sterility | Nationwide |