Phenylephrine Injectable Syringes Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 4,100 syringes of phenylephrine injectable solution due to inadequate validation of sterilization cycles. The lack of documented sterilization assurance creates potential for microbial contamination.
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: This is an FDA Class II recall of injectable medication where the hazard is lack of sterility assurance due to unvalidated sanitization processes. No illnesses or injuries have been reported, and the risk is theoretical rather than confirmed. Per the rubric, theoretical risks without reported harm score as High.
Plain-English summary
Central Admixture Pharmacy Services, Inc. has recalled 4,100 syringes of phenylephrine 1,000 mcg/10 mL (100 mcg/mL) injectable solution. The product was distributed nationwide across the United States.
The manufacturer lacks validation data demonstrating that sterilization cycles used in production adequately eliminate microorganisms. Without documented evidence that sanitization processes meet required standards, the company cannot assure the product meets FDA sterility requirements for injectable medications.
Phenylephrine is a vasoconstrictor medication administered intravenously or intramuscularly in clinical settings. Without verified sterilization, the product poses a potential risk of microbial contamination and associated infection.
Affected lot numbers are 36-262311, 36-262312, 36-262313, and 36-262314 (expiring 10/5/2023) and 36-262737, 36-262738, 36-262739, 36-262740, 36-262741, and 36-262742 (expiring 10/11/2023). Healthcare facilities and distributors should identify and quarantine affected units by lot number and not administer them to patients.
The recalled product
- Product
- PHENYLephrine 1,000 mcg/10mL, (100mcg/mL) in 0.9% sodium chloride, 10 mL Syringe, Rx Only, CAPS, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6009-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Injectable Medication
- Affected units
- 4,100
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 (12)
- Lot# 36-262312
- 36-262314
- 36-262311
- 36-262313
- Exp 10/5/2023
- 36-262739
- 36-262742
- 36-262741
- 36-262740
- 36-262738
- 36-262737
- Exp 10/11/2023.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 32 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 32 products in this recall →Related recalls
Same manufacturer · Central Admixture Pharmacy Services, Inc.
See all →- ModeratePediatric TPN Bags Recalled for Incorrect Formulation
FDA (Drugs) · 2026-08-12
- SeverePediatric Total Parenteral Nutrition Bag Recalled for Incorrect Formulation
FDA (Drugs) · 2026-07-01
- SevereInjectable Phenylephrine Solution Recalled Due to Particulate Matter Contamination
FDA (Drugs) · 2025-03-19
- HighEphedrine Injectable Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-10-11
- HighFentanyl injectable syringes recalled nationwide for sterility assurance failure
FDA (Drugs) · 2023-10-11
Same hazard · lack of sterility
See all →- SevereK.C. Pharmaceuticals Recalls Dry Eye Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Multiple Brands of Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Assurance Issues
FDA (Drugs) · 2026-09-30
- SevereGentle Eyes Lubricant Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
Similar recalls
- HighPHENYLephrine Injectable Syringe Recall Due to Insufficient Sterility Assurance
FDA (Drugs) · 2023-08-09
- HighPhenylephrine Injection Syringes Recalled Due to Sterility Validation Failure
FDA (Drugs) · 2023-08-09
- HighPhenylephrine Injectable Syringes Recalled Due to Sterility Validation Deficiency
FDA (Drugs) · 2023-08-09
- HighPhenylephrine Injectable Syringes Recalled for Sterility Assurance
FDA (Drugs) · 2023-10-11
- HighPhenylephrine injectable drug recalled due to sterility assurance failure
FDA (Drugs) · 2023-10-11
- HighPhenylephrine Syringes Recalled Nationwide for Sterility Assurance Failure
FDA (Drugs) · 2023-10-11