FDA drug recalls · openFDA
Is SODIUM CHLORIDE recalled?
The FDA has recorded 25 recalls of SODIUM CHLORIDE (2023–2026) , recalled under brand like SODIUM CHLORIDE. 21 still ongoing.
2
Class I (most serious)
22
Class II
1
Class III
21
ongoing
A recall doesn't mean your pills are affected
Drug recalls are issued by lot (specific batches, identified by lot numbers / NDC) — not for every bottle of SODIUM CHLORIDE ever made. To know if yours is involved, match the lot codes on the recall below against your bottle, or ask your pharmacist. Do not stop a prescribed medication because of a recall without talking to your pharmacist or prescriber — stopping can be more dangerous than the recall. The Class is the FDA's risk judgment (Class I = reasonable probability of serious harm or death), not a measurement that harm occurred; most recalls are voluntary and Class II/III.
Why it was recalled
Lack of Assurance of Sterility 13
Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Conta 2
Presence of Particulate Matter 2
Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites. 1
Presence of Particulate Matter. 1
The recalls
Class I and ongoing recalls first. Tap a recall for its full record and lot detail.
0.9% Sodium Chloride Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, ND Class I ongoing
B BRAUN MEDICAL INC 2025-08-18 lots: Lot #: V3K770, Exp 1/31/2026
0.9% Sodium Chloride Injection USP, E8000, 1000mL container, Rx only, B. Braun Medical Inc., Irvine, CA, NDC 0264-7800-0 Class I ongoing
B. Braun Medical Inc 2024-07-24 lots: Lot #: J2L763, J2L764, Exp: 31 March 2025
0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 mL in a 250 mL freeflex bag, Rx only, Frese Class II ongoing
Fresenius Kabi USA, LLC 2026-03-11 lots: Batch# 23SU10008, Exp Date: 12/31/2026; Batch# 24JU10003, Exp Date: 07/31/2027; Batch# 24LU10011, 24LU10012, Exp Date: 9/30/2027; Batch# 6402273, 6402275, Exp Date: 01/31/2028; Batch# 6402420, 6402421, 6402422, 6402423, Exp Date: 03/31/2028; Batch# 6402473, 6402474, 6402475, 6402476, 6402485, Exp Date: 04/30/2028; Batch# 6402516, Exp Date: 05/31/2028.
0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 250 mL in a 250 mL freeflex bag, Rx only, Class II ongoing
Fresenius Kabi USA, LLC 2026-03-11 lots: Batch # 6402413, Exp Date: 02/29/2028
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, M Class II ongoing
Fresenius Kabi USA, LLC 2026-03-11 lots: Batch# 23DU10004, Exp Date: 04/30/2026; Batch# 23HU10006, Exp Date: 06/30/2026.
0.9% Sodium Chloride Injection, USP, 0.9% (900 mg per 100 mL) (9 mg per mL) 100 mL in a 100 mL freeflex bag, Rx only, Fr Class II ongoing
Fresenius Kabi USA, LLC 2026-03-11 lots: Batch# 6402299, 6402300, 6402301, 6402302, 6402303, Exp Date: 01/31/2027; Batch# 6402305, 6402398, Exp Date: 02/28/2027; Batch# 6402467, Exp Date: 04/30/2027; Batch# 6402577, 6402578, Exp Date: 06/30/2027.
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, Frese Class II ongoing
Fresenius Kabi USA, LLC 2026-03-11 lots: Batch# 24LU10013, 24LU10014, Exp Date: 09/30/2027; Batch# 24NU10001, 24NU10002, Exp Date: 10/31/2027.
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 B Class II ongoing
Fresenius Kabi USA, LLC 2026-03-11 lots: 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.
0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose, Preservative Free, Manufactured for: Spectra M Class II ongoing
Huons Co., Ltd. 2026-04-02 lots: All lots within expiry
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 Class II ongoing
Fresenius Kabi USA, LLC 2026-03-11 lots: 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.
0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) (9 mg per mL) 50 mL, Rx only, Fresenius Kabi USA, LLC ("Fres Class II ongoing
Fresenius Kabi USA, LLC 2026-03-11 lots: Batch# 6402372, 6402374, Exp Date: 08/31/2026; Batch# 6402437, Exp Date: 10/31/2026.
0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 U Class II ongoing
Fresenius Kabi USA, LLC 2026-03-11 lots: Batch# 6402428, Exp Date: 10/31/2026; Batch# 6402481, 6402482, Exp Date: 11/30/2026.
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 B Class II ongoing
Fresenius Kabi USA, LLC 2026-03-11 lots: 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.
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 Class II ongoing
Fresenius Kabi USA, LLC 2026-03-11 lots: Batch# 24EU10010, Exp Date: 05/31/2027.
0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose containe Class II ongoing
B BRAUN MEDICAL INC 2025-08-04 lots: Lot #: J5C919, Exp. 08/31/2027
0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham, Class II ongoing
Fresenius Medical Care Holdings, Inc. 2025-05-27 lots: 24PU06037, 24PU06038, 24PU06040, 24PU06041, 24PU06042, 24PU06043, 24PU06044, 24PU06045, 24PU0646, 24PU06047, 24PU06048, 24PU06049, 24PU06050, 24PU06052, 24PU06053, 24PU06054 & 24PU06055, Exp Date 11/30/2025; 24SU06001, 24SU06002, 24SU06003, 24SU06004, 24SU06005, 24SU06006, 24SU06007, 24SU06009, 24SU06010, 24SU06011 24SU06012, 24SU06013, 24SU06014, 24SU06015, 24SU06016, 24SU06017, 24SU06018, 24SU06019, 24SU06020, 24SU06021, 24SU06022, 24SU06023, 24SU06024, 24SU06025,24SU06026, 24SU06028,24SU06029, 24SU06030, 24SU06031, 24SU06032, 24SU06033 24SU06034, 24SU06035, 24SU06036, 24SU06037, 24SU06038, 24SU06039, 24SU06040, 24SU06041, 24SU06042, 24SU06043, 24SU06044, 24SU06045, 24SU06046, 24SU06047, 24SU06048, 24SU06049, 24SU06050, 24SU06051, 24SU06052, 24SU06053, 24SU06054, 24SU06055, 24SU06056, & 24SU06057, Exp Date 12/31/25 25AU06001, 25AU06002, 25AU06003. 25AU06004, 25AU06005, 25AU06006, 25AU06007, 25AU06008, 25AU06009, 25AU06010, 25AU06011, 25AU06013, 25AU06017, 25AU06020 25AU06021, 25AU06022, 25AU06027, 25AU06028, 25AU06029, 25AU06030, 25AU06031 25AU06032, 25AU06034, 25AU06035, 25AU06036, 25AU06037, 25AU06038, 25AU06039 25AU06040, 25AU06041, 25AU06042, 25AU06043, 25AU06044, 25AU06045, 25AU06046 25AU06047, 25AU06048, 25AU06049, 25AU06050, 25AU06051, 25AU06052, 25AU06053 & 25AU06056, Exp Date 1/31/26 25BU06001, 25BU06003, 25BU06004, 25BU06005, 25BU06006, 25BU06007, 25BU06008 25BU06009, 25BU06010, 25BU06011, 25BU06018, 25BU06020, 25BU06023, 25BU06024 25BU06026, 25BU06027, 25BU06028, 25BU06030, 25BU06031, 25BU06032, 25BU06033 25BU06034, 25BU06035, 25BU06036, 25BU06037, 25BU06038, 25BU06039, 25BU06040 25BU06041, 25BU06042, 25BU06043, 25BU06044, 25BU06045, 25BU06046 25BU06047, 25BU06049, 25BU06050, 25BU06051, 25BU06053 & 25BU06054, Exp Date 02/28/26 25CU06002, 25CU06003, 25CU06004, 25CU06005, 25CU06006, 25CU06007, 25CU06008 25CU06012, 25CU06013, 25CU06015, 25CU06016, 25CU06020, 25CU06021, 25CU06022 25CU06023, 25CU06024, 25CU06026, 25CU06028, 25CU06030, 25CU06032, 25CU06035 25CU06039, Exp Date 03/31/2026
0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-798 Class II ongoing
Otsuka ICU Medical LLC 2025-10-27 lots: Lot # 1029921, Exp Date: 28 February 2027
0.9% Sodium chloride Irrigation USP, Isotonic Solution for Irrigation, 500 mL Plastic Irrigation Container (PIC), B. Bra Class II ongoing
B. Braun Medical Inc 2025-03-31 lots: Lot # J4K936, Exp 7/31/2027
0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged 24 per case, Rx onl Class II ongoing
B BRAUN MEDICAL INC 2025-06-16 lots: Lot #: J4L260, J4L261, J4L270, J4L271, J4L280, Exp 2/28/2027
0.9% Sodium Chloride Injection, USP, 500 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, ND Class II Completed
B. Braun Medical Inc. 2023-02-10 lots: Lots: 0061794230 Exp. 01/31/2024; 0061794232 Exp. 01/31/2024; 0061797779 Exp. 02/29/2024; 0061797780 Exp. 02/29/2024; 0061797781 Exp. 02/29/2024; 0061797783 Exp. 02/29/2024; 0061797784 Exp. 03/31/2024; 0061797785 Exp. 03/31/2024; 0061797786 Exp. 03/31/2024; 0061797787 Exp. 03/31/2024; 0061797788 Exp. 03/31/2024; 0061809680 Exp. 04/30/2024
0.9% Sodium Chloride Injection, USP, 1000 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, N Class II Completed
B. Braun Medical Inc. 2023-02-10 lots: Lots: 0061786962 Exp. 11/30/2023; 0061797767 Exp. 04/30/2024; 0061797768 Exp. 05/31/2024; 0061787769 Exp. 05/31/2024; 0061797770 Exp. 05/31/2024; 0061797771 Exp. 05/31/2024; 0061797772 Exp. 05/31/2024; 0061797773 Exp. 05/31/2024; 0061797774 Exp. 05/31/2024; 0061797775 Exp. 05/31/2024; 0061797776 Exp. 05/31/2024; 0061812946 Exp. 05/31/2024; 0061812947 Exp. 05/31/2024; 0061812948 Exp. 05/31/2024; 0061812949 Exp. 05/31/2024; 0061812950 Exp. 05/31/2024; 0061816017 Exp. 06/30/2024; 0061816018 Exp. 06/30/2024; 0061816019 Exp. 06/30/2024; 0061816020 Exp. 06/30/2024; 0061816021 Exp. 06/30/2024; 0061816358 Exp. 06/30/2024; 0061816359 Exp. 06/30/2024; 0061816361 Exp. 07/31/2024; 0061816362 Exp. 07/31/2024; 0061816363 Exp. 07/31/2024; 0061816364 Exp. 07/31/2024; 0061818516 Exp. 07/31/2024; 0061818517 Exp. 07/31/2024; 0061818518 Exp. 07/31/2024; 0061821562 Exp. 08/31/2024; 0061821563 Exp. 08/31/2024; 0061821564 Exp. 08/31/2024; 0061823709 Exp. 08/31/2024; 0061823710 Exp. 08/31/2024; 0061823711 Exp. 08/31/2024; 0061823714 Exp. 08/31/2024; 0061823715 Exp. 08/31/2024; 0061823716 Exp. 08/31/2024; 0061824770 Exp. 08/31/2024; 0061824771 Exp. 08/31/2024; 0061824772 Exp. 08/31/2024; 0061824773 Exp. 08/31/2024; 0061824774 Exp. 08/31/2024; 0061824775 Exp. 08/31/2024; 0061824776 Exp. 08/31/2024; 0061824777 Exp. 08/31/2024; 0061826486 Exp. 08/31/2024; 0061826487 Exp. 08/31/2024; 0061826488 Exp. 08/31/2024
0.9% Sodium Chloride Injection, USP, 100 mL Single-Dose Container bag, Rx Only, Nephron Pharmaceuticals Corporation, 450 Class II Terminated
Nephron Sc Inc 2023-01-12 lots: Lot: 271043, Exp. 03/2023
Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America, Wa Class II Terminated
Fresenius Medical Care Holdings, Inc. 2023-05-23 lots: Lot # 23AU05030, Exp 01/13/2024; 23AU05035, Exp 01/15/2024
0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018-352 Class II Terminated
B. Braun Medical Inc. 2023-07-05 lots: Lot#: 0061858305, 0061858306 Exp 3/31/2025
0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018, ND Class III Terminated
B. Braun Medical Inc. 2023-08-02 lots: Lot #: 0061852531, Exp 2/28/2025
RECORDED — these are the FDA's published recall enforcement records (openFDA), grouped by the generic drug name. Scope: drug recalls the FDA recorded with a generic name; device recalls and recalls without a generic name are in the full recall browse. "Ongoing" reflects openFDA's last-published status — confirm current status and your lot at the FDA recall database. This page informs and routes; it is not medical advice.