CLASS II Drug recall · Reported 30 Mar 2022 · FDA Enforcement Report
Phenylephrine HCl Injection 50 mg recalled by Athenex Pharma Solutions
Athenex Pharma Solutions is recalling Phenylephrine HCl Injection 50 mg per in 0.9% Sodium Chloride, 50 mg excel, distributed nationwide in the US. The recall was initiated on 14 Mar 2022 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-0710-2022
- FDA event ID
- 89779
- Recalling firm
- Athenex Pharma Solutions, Clarence, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Mar 2022
- FDA classified
- 21 Mar 2022
- Reported
- 30 Mar 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Cold & Cough Medicine
Timeline
| 14 Mar 2022 | Recall initiated by company | |
| 21 Mar 2022 | Classified by FDA | +7 days |
| 30 Mar 2022 | 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
Defective container
Product as listed by the FDA
Phenylephrine HCl Injection 50 mg per 250 mL in 0.9% Sodium Chloride, 50 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-494-15
Where it was distributed
USA nationwide.
Questions about this recall
Why was it recalled?
Defective container
Which lots are affected?
Lot #: F2101652, F2101653, Exp 5/30/22; F2200111, Exp 7/27/22
Where was it sold?
USA 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.
Other products in this recall event
6 other products · FDA event 89779This product is part of a recall event; the main page for the event is Epinephrine Injection 8 mg per in 0.9% Sodium Chloride, 8mg excel recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Epinephrine Injection 8 mg per in 0.9% Sodium Chloride, 8mg excel recalled | Athenex Pharma Solutions | Other | Nationwide | |
| CLASS II | Norepinephrine Bitartrate Injection 8 mg recalled | Athenex Pharma Solutions | Other | Nationwide | |
| CLASS II | Norepinephrine Bitartrate Injection 16 mg per added recalled | Athenex Pharma Solutions | Other | Nationwide | |
| CLASS II | Phenylephrine HCl Injection in 0.9% Sodium Chloride, 20 mg excel recalled | Athenex Pharma Solutions | Other | Nationwide | |
| CLASS II | Phenylephrine HCl Injection 40 mg recalled by Athenex Pharma Solutions | Athenex Pharma Solutions | Other | Nationwide | |
| CLASS II | Norepinephrine Bitartrate Injection 4mg recalled | Athenex Pharma Solutions | Other | Nationwide |
More recalls from Athenex Pharma Solutions
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Norepinephrine Bitartrate Injection 4mg recalled | Athenex Pharma Solutions | Other | Nationwide |
| Drug | CLASS II | Phenylephrine HCl Injection 40 mg recalled by Athenex Pharma Solutions | Athenex Pharma Solutions | Other | Nationwide |
| Drug | CLASS II | Phenylephrine HCl Injection in 0.9% Sodium Chloride, 20 mg excel recalled | Athenex Pharma Solutions | Other | Nationwide |
| Drug | CLASS II | Norepinephrine Bitartrate Injection 16 mg per added recalled | Athenex Pharma Solutions | Other | Nationwide |
| Drug | CLASS II | Norepinephrine Bitartrate Injection 8 mg recalled | Athenex Pharma Solutions | Other | Nationwide |
Other Phenylephrine Per recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Phenylephrine HCl 1mg per (100 mcg/mL) syringes recalled | Denver Solutions | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Phenylephrine HCl 0.5 mg per (100 mcg/mL) Syringe recalled | Denver Solutions | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Phenylephrine HCl Injection 40 mg recalled by Athenex Pharma Solutions | Athenex Pharma Solutions | Other | Nationwide |