Pharmedium Recalls Potassium Chloride Infusions Due to Sterility Concerns
Pharmedium Services, LLC is recalling all lots of Potassium Chloride in 0.9% Sodium Chloride due to a lack of 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric for significant injury or property damage reports, or high-risk contamination.
Plain-English summary
Pharmedium Services, LLC is voluntarily recalling all strengths, doses, and packaging of Potassium Chloride in 0.9% Sodium Chloride. The recall is being conducted because of a lack of sterility assurance for the product.
The affected product is distributed nationwide in the United States. The recall includes all lots that are remaining within their expiration dates.
Healthcare providers and consumers should stop using the recalled product and contact Pharmedium Services, LLC for further instructions or a replacement.
The recalled product
- Product
- Potassium Chloride in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — IV Infusion
- 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 (1)
- All lots remaining within expiry.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 42 recalled by Pharmedium Services, LLC 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 42 products in this recall →Related recalls
Same manufacturer · Pharmedium Services, LLC
See all →- SeverePharMEDium Recalls nICARdipine HCl Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2020-04-15
- SeverePharMEDium Recalls ePHEDrine Sulfate Syringes Due to Sterility Assurance Issues
FDA (Drugs) · 2020-04-15
- SeverePharMEDium Recalls Fentanyl Citrate Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2020-04-15
- SeverePharMEDium Recalls Fentanyl Citrate Infusions Due to Sterility Assurance Issues
FDA (Drugs) · 2020-04-15
- SeverePharMEDium Recalls Rocuronium Bromide Syringes Due to Sterility Assurance Issues
FDA (Drugs) · 2020-04-15
Same hazard · sterility
See all →- HighFDA recalls injectable compounded mixture in single-use syringes
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tirzepatide Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tirzepatide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Leader Advanced Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
Similar recalls
- HighPharMedium Recalls Potassium Phosphate Injection Due to Sterility Concerns
FDA (Drugs) · 2017-07-26
- SeverePharm D Solutions Recalls 0.9% Sodium Chloride Injection Bags Due to Sterility Concerns
FDA (Drugs) · 2018-11-07
- SeverePotassium Chloride Injection Recall Due to Sterility Assurance Lack
FDA (Drugs) · 2021-10-20
- SevereFresenius Recalls 0.9% Sodium Chloride Injection Due to Sterility Concerns
FDA (Drugs) · 2018-05-30
- HighInjectable Sodium Chloride Solution Recalled Due to Sterility Concerns and Leakage
FDA (Drugs) · 2022-12-14
- SevereSodium Chloride Injection Recalled Due to Lack of Assurance of Sterility
FDA (Drugs) · 2026-04-15