Phenylephrine Injectable Solution Recalled for Sterility Assurance Issues
Central Admixture Pharmacy Services is recalling 6,407 bags of phenylephrine injectable solution nationwide because FDA inspection questioned the sterility assurance of the product.
What this means for you
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 with no reported illnesses or injuries. The hazard—lack of sterility assurance in an injectable product—represents a risk-of-harm scenario where injury has not yet been reported, placing it in the High (3) severity category.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling phenylephrine added to 0.9% sodium chloride injection (10 mg/250 mL, 40 mcg/mL) supplied in 250 mL bags. Approximately 6,407 bags have been distributed nationwide.
An FDA inspection questioned whether the product maintains its required sterility. Because these injections must be sterile for safe use, the lack of assured sterility necessitates the recall.
The affected lots include 37-884272, 37-887513, 37-888083, 37-889123, 37-889423, 37-891563, 37-892577, 37-892582, 37-893248, 37-893257, 37-894436, 37-895805, and 37-898324, with expiration dates between May 3, 2023 and June 28, 2023.
The recalled product
- Product
- PHENYLephrine added to 0.9% sodium chloride, 10 mg/250 mL* (40 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6058-1.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Injectable Solution
- Affected units
- 6,407
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 # 37-884272
- Exp 05/03/2023
- 37-887513
- Exp 05/16/2023
- 37-888083
- Exp 05/18/2023
- 37-889123
- 37-889423
- Exp 05/23/2023
- 37-891563
- Exp 06/01/2023
- 37-892577
- 37-892582
- Exp 06/06/2023
- 37-893248
- 37-893257
- Exp 06/08/2023
- 37-894436
- Exp 06/13/2023
- 37-895805
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 →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
- HighInjectable Lidocaine Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2023-10-11
- HighMidazolam Injectable Solution Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2023-10-11
Same hazard · lack of sterility
See all →- HighRohto Cooling Eye Drops Max Strength Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- HighRohto Cooling Eye Drops Recalled Due to Lack of Assurance of Sterility
FDA (Drugs) · 2026-07-29
- SevereCleviprex Injectable Emulsion Recall Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-07-22
- SeverePemetrexed for Injection recalled due to lack of sterility assurance
FDA (Drugs) · 2026-07-15
- SevereAzacitidine for Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15