CLASS II ONGOING Drug recall · Reported 10 Dec 2025 · FDA Enforcement Report
Phenylephrine HCI, 1000 mcg / Total Volume recalled
Park Avenue Compounding is recalling Phenylephrine HCI, 1000 mcg / Total Volume, distributed in Missouri. The recall was initiated on 17 Sep 2025 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-0200-2026
- FDA event ID
- 97960
- Recalling firm
- Park Avenue Compounding, Saint Louis, MO
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Sep 2025
- FDA classified
- 2 Dec 2025
- Reported
- 10 Dec 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Cold & Cough Medicine
Timeline
| 17 Sep 2025 | Recall initiated by company | |
| 2 Dec 2025 | Classified by FDA | +76 days |
| 10 Dec 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations
Product as listed by the FDA
Phenylephrine HCI, 1000 mcg / 10 mL, 10 mL Total Volume, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO, 63110-2512, NDC 83863-0104-1.
Where it was distributed
MO
Questions about this recall
Why was it recalled?
CGMP Deviations
Which lots are affected?
Lot # 20250813-13D65E, Exp Date: FEB-09-2026.
Where was it sold?
MO
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 Park Avenue Compounding
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Fentanyl citrate, 2 mcg / ml / Ropivacaine, 0.2% in NS, CII recalled | Park Avenue Compounding | Manufacturing (CGMP) Deviations | MO |
Other Phenylephrine Hci recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Phenylephrine HCI Injection, USP, 10mg/mL recalled by Sandoz | Sandoz | Sterility | Nationwide |
| Drug | CLASS II | Phenylephrine HCI 40mg/ in 0.9% Sodium Chloride recalled | Pharmakon Pharmaceuticals | Sterility | Nationwide |