CLASS II Drug recall · Reported 28 Sep 2016 · FDA Enforcement Report
Ephedrine Sulfate Injection, USP, 50 mg/mL Fill in a Vial recalled
Sandoz is recalling Ephedrine Sulfate Injection, USP, 50 mg/mL Fill in a Vial (, distributed nationwide in the US. The recall was initiated on 24 Aug 2016 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-1513-2016
- FDA event ID
- 75032
- Recalling firm
- Sandoz, Princeton, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Aug 2016
- FDA classified
- 19 Sep 2016
- Reported
- 28 Sep 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 24 Aug 2016 | Recall initiated by company | |
| 19 Sep 2016 | Classified by FDA | +26 days |
| 28 Sep 2016 | Published in enforcement report | +9 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 recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.
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 Injection, USP, 50 mg/mL, 1 mL Fill in a 2mL Vial (NDC 66758-008-01), packaged in 25 x 2 mL Vials per carton (NDC 66758-008-02), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540.
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.
Which lots are affected?
Lot #: 080514, 080614, 081114, 081214, 081314, 081414, 082714, 082814, 082914, Exp 08/16; 090214, 090314, 090814, 090914, 091014, 091114, 091214, 091514, Exp 09/16
Where was it sold?
Nationwide and Puerto Rico
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
1 other product · FDA event 75032This product is part of a recall event; the main page for the event is Phenylephrine HCI Injection, USP, 10mg/mL recalled by Sandoz.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Phenylephrine HCI Injection, USP, 10mg/mL recalled by Sandoz | Sandoz | Sterility | Nationwide |
More recalls from Sandoz
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|---|---|---|---|---|---|
| Drug | CLASS III | Focalin XR (dexmethylphenidate HCl) 5 mg recalled by SandozFocalin | Sandoz | Other | Nationwide |
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| Drug | CLASS I | Buffered Penicillin G Potassium for Injection recalled by SandozPenicillin G Potassium | Sandoz | Labeling Errors | Nationwide |
| Drug | CLASS I | Cefazolin for Injection, USP per vial, Sterile recalled by SandozCefazolin | Sandoz | Packaging Defects | 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 |