Class IIOngoing
Baxter Healthcare Corporation recalls 17 products
Recall date · record updated Sep 9, 2026 · Source: U.S. Food and Drug Administration (openFDA drug enforcement)
Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.
- Company
- Baxter Healthcare Corporation
- Reason
- CGMP Deviations
- Hazard
- FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
- Who’s affected
- US Nationwide; Puerto Rico; and Chile.
- Where
- Nationwide
- Official notice
- www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99500…
Products (17)
Vancomycin Injection, USP in 5% Dextrose, 1 g per 200mL (5 mg/mL), in GALAXY Single-Dose Container, Rx only, Sterile Nonpyrogenic, Iso-osmotic, Baxter Healthcare Corporation, Deerfield, IL, 60015 USA, NDC 0338-3552-48.
Codes/lots: Lot # NC188678, Exp Date: 12/1/2026; Lot # NC188814, Exp Date: 12/5/2026; Lot # NC188944, Exp Date: 12/8/2026; Lot # NC193610, Exp Date: 4/21/2027, Lot # NC193665, Exp Date: 4/23/2027.Quantity: N/ARecall no. D-0805-2026Class IIMYXREDLIN, Insulin Human in 0.9% Sodium Chloride Injection, 100 units/100 mL (1 unit/mL), Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0126-12.
Codes/lots: Lot # NC188630, NC188708, NC188791, NC188845, NC188876, NC188968, Exp Date: 12/31/2027; Lot # NC193719, NC193849, Exp Date: 04/30/2028; Lot # NC194051, NC194105, Exp Date: 05/31/2028; Lot # NC195171, Exp Date: 06/30/2028.Quantity: N/ARecall no. D-0806-2026Class IIDaptomycin, in 0.9% Sodium Chloride Injection, 500 mg per 50 mL (10 mg/mL), 500 mg total, in 50 mL Single Dose Container (24 bags/carton), Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0714-24.
Codes/lots: Lot # NC188692, Exp Date: 11/22/2027.Quantity: N/ARecall no. D-0807-2026Class IIClindamycin Injection USP in 5% Dextrose, 600 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-3612-50.
Codes/lots: Lot # NC193764, Exp Date: 10/18/2027; Lot # NC195232, Exp Date: 11/25/2027.Quantity: N/ARecall no. D-0808-2026Class IIFamotidine Injection in Sodium Chloride Injection, 20 mg, 50 mL in GALAXY Single Dose Container, Rx Only, Sterile Nonpyrogenic, Baxter International Inc., Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-5197-41.
Codes/lots: Lot # NC188586, Exp Date: 02/28/2027; Lot # NC188913, Exp Date: 3/9/2027.Quantity: N/ARecall no. D-0809-2026Class IIDexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection, 400 mcg per 100 mL (4 mcg/mL) in Galaxy 100 mL Single Dose Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-9557-12.
Codes/lots: Lot # NC188654, Exp Date: 08/31/2027; Lot # NC188821, Exp Date: 09/30/2027; Lot # NC193658, NC193702, Exp Date: 01/31/2028.Quantity: N/ARecall no. D-0810-2026Class IIVasopressin, in 0.9% Sodium Chloride Injection, 20 units per 100 mL (0.2 units/mL), 100mL Single-Dose Container, Rx only, Sterile, Baxter Healthcare Corporation, Deerfield, IL, 60012 USA, NDC 0338-9640-12.
Codes/lots: Lot # NC193672, NC193795, Exp Date: 04/30/2028; Lot # NC194198, Exp Date: 05/31/2028.Quantity: N/ARecall no. D-0811-2026Class IIPantoprazole Sodium in 0.9% Sodium Chloride Injection, 80 mg/100 mL (0.8 mg/mL) Single-Dose Infusion Bag in 100 mL GALAXY Container, Rx only, Sterile, Baxter Healthcare Corporation, Deerfield, IL, 60015, USA, NDC 0338-9648-12.
Codes/lots: Lot # NC194129, Exp Date: 05/07/2028.Quantity: N/ARecall no. D-0812-2026Class IICARDENE IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection, 40 mg in 200 mL (0.2 mg/mL) in GALAXY Single-Dose Container, Manufactured and Marketed by: Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 43066-016-10.
Codes/lots: Lot # NC177818, Exp Date: 12/31/2026; Lot # NC188869, Exp Date: 12/31/2027.Quantity: N/ARecall no. D-0813-2026Class IINexterone (amiodarone HCI), 360 mg/200 mL (1.8 mg/mL) in GALAXY Single-Dose Container, sterile, Nonpyrogenic, iso-osmotic solution in Dextrose, Baxter Healthcare Corporation, Deerfield, IL 60015, Made in the USA, NDC 43066-360-20.
Codes/lots: Lot # NC177832, Exp Date: 12/31/2026; Lot # NC185417, NC185455, Exp Date: 08/31/2027; Lot # NC188593, Exp Date: 11/30/2027; Lot # NC188647, NC188685, NC188807, NC188838, NC188920, Exp Date: 12/31/2027; Lot # NC193603, NC193726, NC193788, NC193863, NC193900, Exp Date: 04/30/2028; Lot # NC194082, NC194112, NC194143, NC195157, Exp Date: 05/31/2028.Quantity: N/ARecall no. D-0814-2026Class IIClindamycin Injection USP in 5% Dextrose, 900 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-3814-50.
Codes/lots: Lot # NC185424, Exp Date: 2/12/2027; Lot # NC185479, Exp Date: 2/13/2027; Lot # NC193948, Exp Date: 10/23/2027.Quantity: N/ARecall no. D-0815-2026Class IIClindamycin Phosphate in 0.9% Sodium Chloride Injection, 600 mg per 50 mL (12 mg/mL), 50 mL Single-Dose GALAXY Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-9549-50.
Codes/lots: Lot # NC193689, Exp Date: 10/16/2027.Quantity: N/ARecall no. D-0816-2026Class IIClindamycin Injection USP in 5% Dextrose, 900 mg/50 mL (18 mg/mL), in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Manufactured by: Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-4114-50.
Codes/lots: Lot # NC194075, Exp Date: 10/29/2027.Quantity: N/ARecall no. D-0817-2026Class IIClindamycin Injection USP in 5% Dextrose, 900 mg/50 mL (18 mg/mL), in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Manufactured by: Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 43066-995-24.
Codes/lots: Lot # NC194068, Exp Date: 10/29/2027.Quantity: N/ARecall no. D-0818-2026Class IIVasopressin, in 0.9% Sodium Chloride Injection, 40 units per 100 mL (0.4 units/mL), 100mL Single-Dose Container, Rx only, Sterile, Baxter Healthcare Corporation, Deerfield, IL, 60015 USA, NDC 0338-9647-12.
Codes/lots: Lot # NC185448, Exp Date: 8/31/2027; Lot # NC192910, Exp Date: 4/30/2028; Lot # NC195218, Exp Date: 6/30/2028.Quantity: N/ARecall no. D-0819-2026Class IIVancomycin Injection, USP, in 0.9% Sodium Chloride, 1g per 200 mL (5 mg/mL) in GALAXY Single-Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL, 60015 USA, NDC 0338-3583-01.
Codes/lots: Lot # NC193894, Exp Date: 04/25/2027.Quantity: N/ARecall no. D-0820-2026Class IIDaptomycin, in 0.9% Sodium Chloride Injection, 1,000 mg per 100 mL (10 mg/mL), 1,000 mg total, in 1000 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0718-12.
Codes/lots: Lot # NC193856, Exp Date: 04/18/2028.Quantity: N/ARecall no. D-0821-2026Class II
Update history
- First listed on OVERLOOKED from the official record.
When the agency expands or changes this recall, we update this page and log the change here.
Proof: raw official record (JSON) · fetched from FDA API
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