CLASS II ONGOING Drug recall · Reported 24 May 2023 · FDA Enforcement Report
PHENYLephrine HCl Injection, 1 mg per (100 mcg/mL) recalled
Apollo Care is recalling PHENYLephrine HCl Injection, 1 mg per (100 mcg/mL), Single-Use Syringe, Solution for IV, distributed in Missouri. The recall was initiated on 2 May 2023 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-0632-2023
- FDA event ID
- 92348
- Recalling firm
- Apollo Care, Columbia, MO
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 2 May 2023
- FDA classified
- 18 May 2023
- Reported
- 24 May 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Cold & Cough Medicine
Timeline
| 2 May 2023 | Recall initiated by company | |
| 18 May 2023 | Classified by FDA | +16 days |
| 24 May 2023 | Published in enforcement report | +6 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
PHENYLephrine HCl Injection, 1 mg per 10 mL (100 mcg/mL), Single-Use Syringe, Solution for IV Use Only. Apollo Care, LLC, 3801 Mojae Ct., Suite 101, Columbia, MO 65202. NDC: 71170-010-10
Where it was distributed
Missouri only
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lot #: AC-016606, Exp. Date 05/06/2023; AC-016636, Exp. Date 07/09/2023; AC-016643, Exp. Date 07/31/2023
Where was it sold?
Missouri only
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
15 other products · FDA event 92348This product is part of a recall event; the main page for the event is FentaNYL 500 mcg (2mcg/mL) and Ropivacaine HCL 250 mg recalled.
More recalls from Apollo Care
All 34| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Semaglutide 5mg (1mg/mL), Glycine 25 mg recalled by Apollo Care | Apollo Care | Particulate Matter | Nationwide |
| Drug | CLASS II | Semaglutide 4.5mg (0.9 mg/mL) Sterile Multi-Dose Vial recalled | Apollo Care | Particulate Matter | Nationwide |
| Drug | CLASS II | Semaglutide 9mg (4.5 mg/mL) Sterile Multi-Dose Vial recalled | Apollo Care | Particulate Matter | Nationwide |
| Drug | CLASS II | Semaglutide 10mg (5mg/mL), Glycine 10 mg recalled by Apollo Care | Apollo Care | Particulate Matter | Nationwide |
| Drug | CLASS II | Semaglutide 20mg (5mg/mL), Glycine 20 mg recalled by Apollo Care | Apollo Care | Particulate Matter | Nationwide |
Other Phenylephrine recalls
All 122| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Phenylephrine Hydrochloride Injectable Solution, 40mg recalled | Wells Pharma of Houston | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg recalled | Denver Solutions | Sterility | Nationwide |
| Drug | CLASS I | Phenylephrine HCl Injection, USP 100 mg/ (10 mg/mL) vials recalled | Provepharm | Particulate Matter | Nationwide |
| Drug | CLASS II | phenylephrine in 0.9% Sodium Chloride Inj, 1mg per (100 mcg/mL) recalled | Hikma Injectables USA | Sterility | Nationwide |
| Drug | CLASS I | Phenylephrine in 0.9% Sodium Chloride Injection recalled | Hikma Injectables USA | Labeling Errors | 5 states |