Ephedrine Injectable Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 1,590 syringes of ePHEDrine 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 injectable medication recall with lack of sterility assurance. Inability to assure sterility in injectable products represents significant risk of potential contamination. This meets the rubric criterion of risk-of-harm products where injury has not yet been reported, and is capped at High per the rule that theoretical hazards without reported illness score at most 3.
Plain-English summary
Central Admixture Pharmacy Services Inc. is recalling ePHEDrine in 0.9% sodium chloride, 50 mg/5 mL (10 mg/mL), 5 mL Syringe. Approximately 1,590 syringes are affected across lot numbers 17-275252, 17-275276 (expiring 10/2/2023), and 17-275525 (expiring 10/5/2023). The product was distributed nationwide in the United States.
The recall is due to lack of assurance that the product meets sterility standards. For injectable medications, the inability to assure sterility is a critical concern, as injectables must be free from microbial contamination to be safe for use.
Healthcare providers and pharmacies should immediately stop using these syringes and quarantine any remaining stock from the affected lots. Contact Central Admixture Pharmacy Services Inc. or the FDA for instructions on product return or disposal.
The recalled product
- Product
- ePHEDrine in 0.9% sodium chloride, 50 mg/5 mL, (10 mg/mL), 5 mL Syringe, Rx only, CAPS Inc., Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6004-1
- Manufacturer
- Central Admixture Pharmacy Services Inc
- Category
- Drug — Injectable medication
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 (5)
- Lot: 17-275252
- 17-275276
- Exp. 10/2/2023
- 17-275525
- Exp. 10/5/2023
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
- HighKetamine syringes 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
- HighePHEDrine Injectable Syringes Recalled Over Sterility Assurance Gaps
FDA (Drugs) · 2023-08-09
- HighFDA recalls epinephrine injection for lack of sterility assurance
FDA (Drugs) · 2023-05-31
- 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
- SeverePharMEDium Recalls ePHEDrine Sulfate Syringes Due to Sterility Assurance Issues
FDA (Drugs) · 2020-04-15
- HighMorphine Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-08-09