Fresenius Naturalyte Liquid Acid Concentrate Recalled for Labeling Error
Fresenius Medical Care is recalling Naturalyte Liquid Acid Concentrate because the label incorrectly lists the calcium concentration.
The agency’s classification
FDA (Devices): 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a labeling discrepancy regarding calcium concentration without reporting any illnesses or injuries, fitting the criteria for a moderate severity labeling error.
Plain-English summary
Fresenius Medical Care Renal Therapies Group, LLC is recalling 848 units (212 cases) of Fresenius Naturalyte Liquid Acid Concentrate, Catalog Number 08-2301-3. The product is an acid concentrate intended for use in bicarbonate dialysis.
The recall is due to a labeling error on the product. The label incorrectly indicates that the product contains 2.5 mEq/L of calcium (Ca) in the right upper corner. The actual calcium concentration of the final dialysate, as indicated in the list of constituents, is 3.0 mEq/L.
The affected product is Lot Number 15STAC072 with an expiration date of 2017-12-31. Distribution was limited to the states of Kansas, Louisiana, Mississippi, Oklahoma, and Texas. Users should stop using the product and contact the manufacturer for instructions.
The recalled product
- Product
- Fresenius Naturalyte Liquid Acid Concentrate Catalog Number: 08-2301-3 Intended Use: Acid Concentrate for Bicarbonate Dialysis
- 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)
- Lot Number: 15STAC072 Exp Date: 2017-12-31
Distribution
Related recalls
Same manufacturer · Fresenius Medical Care Renal Therapies Group, LLC
See all →- ModerateFresenius CombiSet Hemodialysis Blood Tubing Set Recalled for Handling Review
FDA (Devices) · 2026-09-30
- HighFresenius Recalls Granuflo Dry Acid Concentrate Due to Discoloration
FDA (Devices) · 2026-09-09
- ModerateFresenius NaturaLyte Liquid Acid Concentrate Recalled for Discoloration
FDA (Devices) · 2026-09-09
- ModerateFresenius Citrasate Liquid Acid Concentrate Recalled for Discoloration
FDA (Devices) · 2026-09-09
- SevereFresenius 5008X HD/HDF Blood Tubing Set Recalled for Leak Risk
FDA (Devices) · 2026-09-09
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- HighFresenius Naturalyte Liquid Acid Concentrate Recall for Conductivity Deviation
FDA (Devices) · 2021-01-20
- SevereFresenius Naturalyte Liquid Acid Concentrate Recalled for Conductivity Deviation
FDA (Devices) · 2021-01-20
- ModerateFresenius NaturaLyte Liquid Acid Concentrate Recalled for Mislabeled Part Numbers
FDA (Devices) · 2018-06-13
- HighFresenius NaturaLyte Liquid Acid Concentrate Recall for Low Sodium and Calcium Levels
FDA (Devices) · 2021-01-20
- HighFresenius Naturalyte Liquid Acid concentrate bottles recalled for conductivity deviation
FDA (Devices) · 2021-01-20
- ModerateDialysis concentrate labeling error for chemical composition
FDA (Devices) · 2022-11-16