Phenylephrine injectable drug recalled due to sterility assurance failure
Central Admixture Pharmacy Services Inc is recalling 3,384 phenylephrine syringes due to lack of assurance of sterility. The product was distributed nationwide.
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 for an injectable pharmaceutical with sterility assurance failure. No illnesses, injuries, or deaths are reported; the hazard is theoretical. This qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Central Admixture Pharmacy Services Inc is recalling 3,384 10 mL syringes of phenylephrine in 0.9% sodium chloride (40 mcg/mL) due to lack of assurance of sterility. This injectable pharmaceutical product must remain sterile for safe use.
The affected syringes were distributed nationwide. The product is identified by NDC 71286-6007-1 and includes multiple lot numbers with expiration dates in October 2023: lots 17-275231 and 17-275232 expire 10/2/2023; lots 17-275563, 17-275567, 17-275573, and 17-275580 expire 10/8/2023; and lots 17-275767 and 17-275784 expire 10/10/2023.
Healthcare facilities and individuals who possess this product should not use it due to the sterility assurance failure.
The recalled product
- Product
- PHENYLephrine in 0.9 sodium chloride, 400 mcg/10 mL, (40 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6007-1
- Manufacturer
- Central Admixture Pharmacy Services Inc
- Category
- Drug — Injectable
- Hazard
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 (11)
- Lot: 17-275231
- 17-275232
- Exp. 10/2/2023
- 17-275563
- 17-275567
- 17-275573
- 17-275580
- Exp. 10/8/2023
- 17-275767
- 17-275784
- Exp. 10/10/2023
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 · sterility assurance
See all →- SevereSI-BONE iFuse TORQ Implant System Recalled for Sterility Assurance Issues
FDA (Devices) · 2026-10-21
- HighArrowhead DE LLC Recalls Arrow-LOK Implants Due to Sterility Assurance Concerns
FDA (Devices) · 2026-08-26
- SevereChloraPrep One-Step Applicators Recalled for Potential Packaging Seal Defects
FDA (Drugs) · 2026-07-22
- SeverePemetrexed for Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15
- SevereChloraPrep One-Step Applicators Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2026-07-08
Similar recalls
- HighPhenylephrine Injectable Syringes Recalled Due to Sterility Validation Deficiency
FDA (Drugs) · 2023-08-09
- HighPhenylephrine Injection Syringes Recalled Due to Sterility Validation Failure
FDA (Drugs) · 2023-08-09
- HighPHENYLephrine Injectable Syringe Recall Due to Insufficient Sterility Assurance
FDA (Drugs) · 2023-08-09
- HighPhenylephrine Injectable Syringes Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-09-06
- HighFDA Recalls PHENYLephrine Syringes Due to Sterility Validation Failure
FDA (Drugs) · 2023-08-09
- HighPhenylephrine Injectable Solution Recalled Over Sterility Assurance Failure
FDA (Drugs) · 2023-05-31