Class II · Moderate risk
Phenylephrine Hydrochloride Injectable Solution
cGMP deviations.
PHENYLephrine added to 0.9% sodium chloride
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Presence of Particulate Matter
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
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.
Affected NDC
71285-6092-01
Compare with the code on your package — it is the most precise check available.
Drug: Phenylephrine
- Recalling firm
- Central Admixture Pharmacy Services, Inc.
- NDC code
- 71285-6092-1
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- Company announcement
- Feb 24, 2025 · FDA notice with lot numbers
- FDA recall number
- D-0272-2025 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week.
Other Phenylephrine recalls
See all
Class II · Moderate risk
Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac…
Incorrect Product Formulation
Class II · Moderate risk
Phenylephrine HCI
CGMP Deviations
Class III · Low risk
Tropicamide-Proparacaine-Phenylephrine-Ketorolac
Sub-Potent Drug: Subpotent assay results during stability testing.
Class II · Moderate risk
PHENYLephrine HCl in 0.9% Sodium Chloride
Lack of Assurance of Sterility: Leaking/damaged syringes.
Other recalls by Central Admixture Pharmacy Services, Inc.
All 2025 recalls
Class III · Low risk
Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag
Incorrect Product Formulation
Class II · Moderate risk
Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag
Incorrect product formulation: bag did not contain copper and famotidine per label.
Class II · Moderate risk
HYDROmorphone in dextrose 5%
Lack of assurance of sterility:
Class II · Moderate risk
HYDROmorphone in 0.9% Sodium Chloride
Lack of assurance of sterility:
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