Agency classClass IIOur severity:High FDA (Drugs)·D-0727-2023·Announced 2023-05-31

FDA Recalls Phenylephrine Injectable Due to Sterility Concerns

Central Admixture Pharmacy Services is recalling 5,304 bags of phenylephrine injection nationwide after FDA inspection raised concerns about product sterility assurance.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall of injectable medication with potential sterility issues. No illnesses or injuries reported; the hazard is based on lack of sterility assurance following FDA inspection. This is a risk-of-harm product without reported injury, scoring at the High level per the rubric.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 5,304 bags of phenylephrine injection (25 mg per 250 mL in 0.9% sodium chloride, 100 mcg/mL). The recall was initiated after an FDA inspection called into question the sterility assurance of these injectable products.

The affected product was distributed nationwide throughout the United States. Twelve different lot numbers are included in this recall, with expiration dates ranging from May 2, 2023 to June 29, 2023. The product is identified by NDC 71285-7011-1.

No illnesses or injuries have been reported in connection with this recall. The issue was identified through FDA inspection of the manufacturer's processes.

The recalled product

Product: PHENYLephrine added to 0.9% sodium chloride, 25 mg/250 mL* (100 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7011-1.
Manufacturer: Central Admixture Pharmacy Services, Inc.
Category: Drug — Injectable
Hazard: sterility
Affected units: 5,304

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Lot # 37-883924
Exp 05/02/2023
37-884918
Exp 05/07/2023
37-885677
Exp 05/09/2023
37-887318
Exp 05/16/2023
37-889211
Exp 05/23/2023
37-889848
Exp 05/25/2023
37-891150
Exp 05/31/2023
37-892482
Exp 06/06/2023
37-894484
Exp 06/13/2023
37-896458
37-896480

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 108 recalled by Central Admixture Pharmacy Services, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 108 products in this recall →

Same manufacturer · Central Admixture Pharmacy Services, Inc.

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Severe
Injectable Phenylephrine Solution Recalled Due to Particulate Matter Contamination
FDA (Drugs) · 2025-03-19
High
Ephedrine Injectable Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-10-11
High
Fentanyl injectable syringes recalled nationwide for sterility assurance failure
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Same hazard · sterility