CLASS II Drug recall · Reported 28 Sep 2016 · FDA Enforcement Report
Phenylephrine HCI Injection, USP, 10mg/mL recalled by Sandoz
Sandoz is recalling Phenylephrine HCI Injection, USP, 10mg/mL, 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-1514-2016
- 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
- Cold & Cough Medicine
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
Phenylephrine HCI Injection, USP, 10mg/mL, packaged in a) 5 mL Vial, 50 mg/5 mL (NDC 66758-016-03), 25 x 5 mL Vials per carton (NDC 66758-016-04) and b) 10 mL Vials, 100 mg/10 mL (NDC 66758-017-01), 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 #: a) 091914, Exp 09/16; b) 080114, Exp 08/16; 090414, 092614, 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 75032| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Ephedrine Sulfate Injection, USP, 50 mg/mL Fill in a Vial recalled | Sandoz | Sterility | Nationwide |
More recalls from Sandoz
All 59| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Focalin XR (dexmethylphenidate HCl) 5 mg recalled by SandozFocalin | Sandoz | Other | Nationwide |
| Drug | CLASS II | Cyclophosphamide Injection 500 mg/ (100 mg/mL), Hazardous Drug recalledCyclophosphamide | Sandoz | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension recalledCiprofloxacin And Dexamethasone | Sandoz | Temperature Abuse | CA |
| 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 Phenylephrine Hci recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Phenylephrine HCI, 1000 mcg / Total Volume recalled | Park Avenue Compounding | Manufacturing (CGMP) Deviations | MO |
| Drug | CLASS II | Phenylephrine HCI 40mg/ in 0.9% Sodium Chloride recalled | Pharmakon Pharmaceuticals | Sterility | Nationwide |