Sodium Acetate Anhydrous is a prescription medicine. The sections below reproduce one FDA label for it, named under "Label". Products in other forms, strengths or from other makers have their own labels, which can differ.
Class I recall (most serious) — September 16, 2026: Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene Only the lots listed are affected. Check the lots
- Type
- Prescription only (Rx)
- Taken
- Intravenous
- Label
- Somerset Therapeutics, LLC, revised October 21, 2025 · full label on DailyMed
- Generic
- No · details
Boxed warning — the FDA's most serious warning for a medicine
Pharmacy Bulk Package. Not for Direct Infusion
What it is used for
Sodium acetate injection (2 mEq/mL) is indicated as a source of sodium for addition to large volume intravenous fluids to prevent or correct hyponatremia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions.
Who should not take it (contraindications)
Sodium acetate injection (2 mEq/mL) is contraindicated in patients with hypernatremia or fluid retention.
Warnings
Sodium acetate injection (2 mEq/mL) must be diluted before use. To avoid sodium overload and water retention, infuse sodium-containing solutions slowly. Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention. In patients with diminished renal function, administration of solutions containing sodium ions may result in sodium retention. Solutions containing acetate ions should be used with great care in patients with metabolic or respiratory alkalosis. Acetate should be administered with great care in those conditions in which there is an increased level or an impaired utilization of this ion, such as severe hepatic insufficiency. The intravenous administration of this solution (after appropriate dilution) can cause fluid and/or solute overloading resulting in dilution of other serum electrolyte concentrations, overhydration, congested states or pulmonary edema. Excessive administration of potassium free solutions may result in significant hypokalemia. WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
Precautions
Do not administer unless solution is clear and seal is intact. Discard unused portion. Sodium replacement therapy should be guided primarily by the serum sodium level. Caution should be exercised in administering sodium-containing solutions to patients with severe renal function impairment, cirrhosis, cardiac failure, or other edematous or sodium-retaining states, as well as in patients with oliguria or anuria. Caution must be exercised in the administration of parenteral fluids, especially those containing sodium ions, to patients receiving corticosteroids or corticotropin. Solutions containing acetate ions should be used with caution as excess administration may result in metabolic alkalosis. Pregnancy : Animal reproduction studies have not been conducted with sodium acetate injection. It is also not known whether sodium acetate injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium acetate injection should be given to a pregnant woman only if clearly needed. Pediatric Use: Safety and effectiveness have been established in the age groups infant to adolescent. Geriatric Use: An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Sodium ions are known to be substantially excreted by the kidney, and the risk of toxic reactions may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Side effects (adverse reactions)
Sodium overload can occur with intravenous infusion of excessive amounts of sodium-containing solutions (See WARNINGS and PRECAUTIONS ).
Is there a generic Sodium Acetate Anhydrous?
No. The FDA has not approved a generic version yet.
Source: Drugs@FDA (via openFDA), checked October 29, 2026. Marketing status is what companies report to the FDA; whether a pharmacy stocks a product, and what your insurance covers, can differ.
Dosage:
we do not reproduce dosing instructions. The right dose depends on the person and the condition and is set by the prescriber or pharmacist. Dosage section of the full label.
Sodium in the news
We have not covered this medicine yet. Latest news
Shortage status
| Product | Availability | Expected supply / notes |
|---|---|---|
| Sodium Acetate, Injection, 164 mg/1 mL (NDC 70069-047-25) Somerset Therapeutics, LLC |
Available | — In shortage · October 27, 2026 |
| Sodium Acetate, Injection, 164 mg/1 mL (NDC 70069-048-20) Somerset Therapeutics, LLC |
Available | — In shortage · October 27, 2026 |
| Sodium Chloride 0.9%, Injection, 50 mL ADD-Vantage® Flexible Container (NDC 0409-7101-66) Hospira, Inc., a Pfizer Company |
Discontinuation of the manufacture of the drug Being discontinued · December 3, 2025 |
|
| Sodium Chloride 0.9%, Injection, 250 mL ADD-Vantage® Flexible Container (NDC 0409-7101-02) Hospira, Inc., a Pfizer Company |
Discontinuation of the manufacture of the drug Being discontinued · December 3, 2025 |
|
| Sodium Chloride 0.9%, Injection, 100 mL ADD-Vantage® Flexible Container (NDC 0409-7101-67) Hospira, Inc., a Pfizer Company |
Discontinuation of the manufacture of the drug Being discontinued · December 3, 2025 |
Recalls
-
Class I Ongoing
0.9% Sodium Chloride Injection, USP, 100 mL Partial Fill in 150 mL PAB Container, Sterile, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018 USA, NDC 0264-1800-32.
Reason: Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene
Lots, distribution and details
- Lots / codes
- Lot #: J6B435, J6B444, J6B457, Exp Date: 30APR2027.
- Distribution
- Nationwide within the United States
- Quantity
- 201,472 total container
- Recall started
- August 19, 2026 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0869-2026
-
Class I Ongoing
0.9% Sodium Chloride Injection USP 500 mL, VIAFLEX Plastic Containers, with 24 units per case. Baxter Healthcare Corporation, Deerfield, IL, 60015, USA, Made in USA, NDC 0338-0049-03
Reason: Presence of particulate matter: Particulates identified as fiberglass
Lots, distribution and details
- Lots / codes
- Lot: Y495523, Y495523A, Exp 31-Oct-2027
- Distribution
- Natonwide in the USA
- Quantity
- 145,464 500mL bags
- Recall started
- August 17, 2026 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0849-2026
-
Class II Ongoing
0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose, Preservative Free, Manufactured for: Spectra Medical Devices, LLC, Wilmington, MA, 01887, By: Houns Co., Ltd, Jecheon, Korea, 27159, NDC 65282-151…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- 0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose, Preservative Free, Manufactured for: Spectra Medical Devices, LLC, Wilmington, MA, 01887, By: Houns Co., Ltd, Jecheon, Korea, 27159, NDC 65282-1510-1.
- Lots / codes
- All lots within expiry
- Distribution
- USA Nationwide.
- Quantity
- 7,120,750 ampules
- Recall started
- April 2, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0531-2026
-
Class II Ongoing
0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL), 1,000 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Becton Drive, Franklin Lakes, NJ 07417, Distributed by BD, Manufactu…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL), 1,000 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Becton Drive, Franklin Lakes, NJ 07417, Distributed by BD, Manufactured by Fresenius Kabi, Unit of Sale NDC Number: 17271-701-07.
- Lots / codes
- Batch# 24EU10010, Exp Date: 05/31/2027.
- Distribution
- US Nationwide , Alaska, and Puerto Rico.
- Quantity
- —
- Recall started
- March 11, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0434-2026
-
Class II Ongoing
0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000 mL in a Single Dose freeflex bag, 1,000 mLx10, Fresenius Medical Care, Waltham, MA 02451, Distributed by: Fresenius Medical Care RTG, LLC, Manufa…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000 mL in a Single Dose freeflex bag, 1,000 mLx10, Fresenius Medical Care, Waltham, MA 02451, Distributed by: Fresenius Medical Care RTG, LLC, Manufactured by: Fresenius Kabi, Unit of Use NDC: 65219-282-01, Unit of Sale NDC Number: 65219-282-10.
- Lots / codes
- Batch# 23SU10001, Exp Date: 12/31/2026; Batch# 24AU10003, 24AU10004, 24AU10005, 24AU10008, Exp Date: 01/31/2027; Batch # 24EU10001, 24EU10002, Exp Date: 05/31/2027; Batch# 24PU10002, Exp Date: 11/30/2027; Batch# 25BU10003, Exp Date: 02/29/2028; Batch# 25EU10005, Exp Date: 05/31/2028.
- Distribution
- US Nationwide , Alaska, and Puerto Rico.
- Quantity
- —
- Recall started
- March 11, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0433-2026
-
Class II Ongoing
0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in a Single Dose freeflex bag, 500 mL x 20, Manufactured for: Fresenius Kabi USA, LLC ("Fresenius Kabi"), IL 60047, Unit of Use NDC: 65219-432-20…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in a Single Dose freeflex bag, 500 mL x 20, Manufactured for: Fresenius Kabi USA, LLC ("Fresenius Kabi"), IL 60047, Unit of Use NDC: 65219-432-20, Unit of Sale NDC Number: 65219-432-85.
- Lots / codes
- Batch# 23DU10004, Exp Date: 04/30/2026; Batch# 23HU10006, Exp Date: 06/30/2026.
- Distribution
- US Nationwide , Alaska, and Puerto Rico.
- Quantity
- —
- Recall started
- March 11, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0432-2026
-
Class II Ongoing
0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 250 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417, Distributed by BD, Manufactur…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 250 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417, Distributed by BD, Manufactured by: Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-05.
- Lots / codes
- Batch# 6402290, 6402291, Exp Date: 01/31/2028; Batch# 6402411, Exp Date: 02/29/2028; Batch# 6402412, 6402419, 6402424, 6402425, 6402426, 6402427, Exp Date: 03/31/2028; Batch# 6402479, 6402480, 6402517, 6402571, Exp Date: 05/31/2028; Batch# 6402518, Exp Date: 06/30/2028.
- Distribution
- US Nationwide , Alaska, and Puerto Rico.
- Quantity
- —
- Recall started
- March 11, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0431-2026
-
Class II Ongoing
0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100 mL in a Single Dose freeflex bag, Rx only, BD Beckton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manuf…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100 mL in a Single Dose freeflex bag, Rx only, BD Beckton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured by: Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-03.
- Lots / codes
- Batch# 6402153, Exp Date: 11/30/2026; Batch# 6402297, 6402298, Exp Date: 01/31/2027; Batch# 6402377, 6402378, 6402379, Exp Date: 02/28/2027; Batch # 6402429, 6402430, 6402431, 6402432, 6402433, Exp Date: 03/31/2027; Batch# 6402434, Exp Date: 04/30/2027; Batch# 6402512, Exp Date: 05/2027; Batch# 6402574, 6402576, Exp Date: 06/30/2027.
- Distribution
- US Nationwide , Alaska, and Puerto Rico.
- Quantity
- —
- Recall started
- March 11, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0430-2026
-
Class II Ongoing
0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured by Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- 0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured by Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-02.
- Lots / codes
- Batch# 6402428, Exp Date: 10/31/2026; Batch# 6402481, 6402482, Exp Date: 11/30/2026.
- Distribution
- US Nationwide , Alaska, and Puerto Rico.
- Quantity
- —
- Recall started
- March 11, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0429-2026
-
Class II Ongoing
0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL in a 500 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-472-05, Unit of…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- 0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL in a 500 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-472-05, Unit of Sale NDC Number: 65219-472-20.
- Lots / codes
- Batch# 24LU10013, 24LU10014, Exp Date: 09/30/2027; Batch# 24NU10001, 24NU10002, Exp Date: 10/31/2027.
- Distribution
- US Nationwide , Alaska, and Puerto Rico.
- Quantity
- —
- Recall started
- March 11, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0428-2026
Have this medicine at home? Compare the lot number and expiry date on your package with the recall. Do not stop taking a prescribed medicine on your own — stopping suddenly can be riskier than the recalled lot. Your pharmacist can check it and usually swap it for an unaffected one.
Get alerts for Sodium Acetate Anhydrous
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Source: FDA structured product labeling, retrieved through openFDA. Label text is shown as published by the FDA, without editing; long sections are shortened, marked […]. openFDA data are not validated for clinical use — always check the current label and ask a doctor or pharmacist about your own treatment. Set ID 93edebd6-ef7f-483a-80b6-bfaf34ea5ded.