CLASS I ONGOING Drug recall · Reported 19 Mar 2025 · FDA Enforcement Report
PHENYLephrine added to 0.9% sodium chloride, 40 mg/* (160 mcg/mL) recalled
Central Admixture Pharmacy Services is recalling PHENYLephrine added to 0.9% sodium chloride, 40 mg/* (160 mcg/mL), distributed nationwide in the US. The recall was initiated on 20 Feb 2025 and the FDA has classified it as Class I.
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-0272-2025
- FDA event ID
- 96307
- Recalling firm
- Central Admixture Pharmacy Services, Allentown, PA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 20 Feb 2025
- FDA classified
- 11 Mar 2025
- Reported
- 19 Mar 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Cold & Cough Medicine
Timeline
| 20 Feb 2025 | Recall initiated by company | |
| 11 Mar 2025 | Classified by FDA | +19 days |
| 19 Mar 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
Presence of Particulate Matter
Product as listed by the FDA
PHENYLephrine added to 0.9% sodium chloride, 40 mg/250 mL* (160 mcg/mL), Rx Only, CAPS, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, 855-275-2270, NDC 71285-6092-1.
Where it was distributed
Product was distributed nationwide within the United States
Questions about this recall
Why was it recalled?
Presence of Particulate Matter
Which lots are affected?
Lot 37-928390, Exp Date, 03MAR2025; Lot 37-928796, Exp Date, 09MAR2025; Lot 37-928839, Exp Date, 10MAR2025
Where was it sold?
Product was distributed nationwide within the United States
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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 Central Admixture Pharmacy Services
All 347Other Phenylephrine Added To Chloride recalls
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | PHENYLephrine added to 0.9% sodium chloride, 20mg/ (80 mcg/mL), IV recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |
| Drug | CLASS II | PHENYLephrine added to 0.9% sodium chloride 50 mg/ (200mcg/mL), IV recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |
| Drug | CLASS II | phenylephrine 50 mg added to 0.9% sodium chloride recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |
| Drug | CLASS III | Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride recalled | New England Life Care | Other | Nationwide |
| Drug | CLASS II | PHENYLephrine added to 0.9% sodium chloride, 20 mg/* (80 mcg/mL) recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |