CLASS II Drug recall · Reported 26 Jul 2023 · FDA Enforcement Report

Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq recalled by SterRx

SterRx is recalling Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per (12.6 mg per mL) Single Dose, distributed nationwide in the US. The recall was initiated on 7 Jul 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: 489344, Exp 25-Jul-23; 489352, Exp 26-Jul-23; 489361, Exp 27-Jul-23; 489387, 491647, Exp 28-Jul-23; 492181, Exp 29-Jul-23; 492199, 492201, Exp 2-Aug-23; 492210, 492228, Exp 3-Aug-23; 492236, 492244, Exp 4-Aug-23; 492261, Exp 5-Aug-23; 492279, 492287, Exp 8-Aug-23; 492295, 492308, Exp 9-Aug-23; 492957, 492965, Exp 19-Sep-23; 492973, 492981, Exp 20-Sep-23; 494194, 494207, Exp 21-Sep-23;494215, 494223, Exp 22-Sep-23; 494231, 495200, Exp 23-Sep-23; 495218, 495453, Exp 26-Sep-23; 495470, 495488, Exp 27-Sep-23; 495496, 495509, Exp 28-Sep-23; 495517, 495525, Exp 29-Sep-23; 495533, Exp 30-Sep-23; 495699, 495701, Exp 3-Oct-23; 495710, 495728, Exp 4-Oct-23; 496106, 497491, Exp 15-Nov-23; 497504, 497512, Exp 16-Nov-23; 497521, 497539, Exp 22-Nov-23; 497547, 497555, Exp 23-Nov-23; 497563, Exp 24-Nov-23; 497571, Exp 29-Nov-23; 497598, Exp 30-Nov-23; 497619, 498363, Exp 1-Dec-23; 498371, 498380, 498398, Exp 5-Dec-23; 498401, Exp 6-Dec-23; 498419, 498427, Exp 7-Dec-23; 498435, Exp 8-Dec-23; 498443, 498451, Exp 12-Dec-23; 498460, Exp 13-Dec-23; 498478, Exp 14-Dec-23; 498507, Exp 24-Jan-24; 498515, 498523, Exp 25-Jan-24; 498531, 498540, Exp 26-Jan-24; 498558, Exp 27-Jan-24; 498574, Exp 30-Jan-24; 498582, 499665, Exp 31-Jan-24; 500355, 500363, Exp 1-Feb-24; 500371, 500380, Exp 2-Feb-24; 500398, 500401, Exp 3-Feb-24; 500419, 500427, Exp 6-Feb-24; 500435, 500443, Exp 7-Feb-24; 500451, 500460, Exp 8-Feb-24; 500478, Exp 9-Feb-24

Quantity recalled137,304 bags

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0930-2023
FDA event ID: 92657
Recalling firm: SterRx, Plattsburgh, NY
Classification: Class II
Status: Terminated
Recall initiated: 7 Jul 2023
FDA classified: 19 Jul 2023
Reported: 26 Jul 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Drug class: Injectable & IV Drugs

Timeline

7 Jul 2023	Recall initiated by company
19 Jul 2023	Classified by FDA	+12 days
26 Jul 2023	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Lack of Assurance of Sterility

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL Single Dose bag, packaged in 1000 mL x 6 units per case, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-326-01.

Where it was distributed

Nationwide in the USA

Nationwide

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility

Which lots are affected?

Lot #: 489344, Exp 25-Jul-23; 489352, Exp 26-Jul-23; 489361, Exp 27-Jul-23; 489387, 491647, Exp 28-Jul-23; 492181, Exp 29-Jul-23; 492199, 492201, Exp 2-Aug-23; 492210, 492228, Exp 3-Aug-23; 492236, 492244, Exp 4-Aug-23; 492261, Exp 5-Aug-23; 492279, 492287, Exp 8-Aug-23; 492295, 492308, Exp 9-Aug-23; 492957, 492965, Exp 19-Sep-23; 492973, 492981, Exp 20-Sep-23; 494194, 494207, Exp 21-Sep-23;494215, 494223, Exp 22-Sep-23; 494231, 495200, Exp 23-Sep-23; 495218, 495453, Exp 26-Sep-23; 495470, 495488, Exp 27-Sep-23; 495496, 495509, Exp 28-Sep-23; 495517, 495525, Exp 29-Sep-23; 495533, Exp 30-Sep-23; 495699, 495701, Exp 3-Oct-23; 495710, 495728, Exp 4-Oct-23; 496106, 497491, Exp 15-Nov-23; 497504, 497512, Exp 16-Nov-23; 497521, 497539, Exp 22-Nov-23; 497547, 497555, Exp 23-Nov-23; 497563, Exp 24-Nov-23; 497571, Exp 29-Nov-23; 497598, Exp 30-Nov-23; 497619, 498363, Exp 1-Dec-23; 498371, 498380, 498398, Exp 5-Dec-23; 498401, Exp 6-Dec-23; 498419, 498427, Exp 7-Dec-23; 498435, Exp 8-Dec-23; 498443, 498451, Exp 12-Dec-23; 498460, Exp 13-Dec-23; 498478, Exp 14-Dec-23; 498507, Exp 24-Jan-24; 498515, 498523, Exp 25-Jan-24; 498531, 498540, Exp 26-Jan-24; 498558, Exp 27-Jan-24; 498574, Exp 30-Jan-24; 498582, 499665, Exp 31-Jan-24; 500355, 500363, Exp 1-Feb-24; 500371, 500380, Exp 2-Feb-24; 500398, 500401, Exp 3-Feb-24; 500419, 500427, Exp 6-Feb-24; 500435, 500443, Exp 7-Feb-24; 500451, 500460, Exp 8-Feb-24; 500478, Exp 9-Feb-24

Where was it sold?

Nationwide in the USA

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

4 other products · FDA event 92657

This product is part of a recall event; the main page for the event is Norepinephrine 4 mg per (16 mcg per mL) recalled by SterRx.

Reported	Class	Recall	Company	Reason	Where
26 Jul 2023	CLASS II	Norepinephrine 4 mg per (16 mcg per mL) recalled by SterRx	SterRx	Sterility	Nationwide
26 Jul 2023	CLASS II	Norepinephrine 16 mg per (64 mcg per mL) recalled by SterRx	SterRx	Sterility	Nationwide
26 Jul 2023	CLASS II	Norepinephrine 8 mg per (32 mcg per mL) recalled by SterRx	SterRx	Sterility	Nationwide
26 Jul 2023	CLASS II	Norepinephrine 32 mg per (128 mcg per mL) recalled by SterRx	SterRx	Sterility	Nationwide

More recalls from SterRx

All 35

Reported	Class	Recall	Company	Reason	Where
26 Jul 2023Drug	CLASS II	Norepinephrine 32 mg per (128 mcg per mL) recalled by SterRx	SterRx	Sterility	Nationwide
26 Jul 2023Drug	CLASS II	Norepinephrine 8 mg per (32 mcg per mL) recalled by SterRx	SterRx	Sterility	Nationwide
26 Jul 2023Drug	CLASS II	Norepinephrine 16 mg per (64 mcg per mL) recalled by SterRx	SterRx	Sterility	Nationwide
26 Jul 2023Drug	CLASS II	Norepinephrine 4 mg per (16 mcg per mL) recalled by SterRx	SterRx	Sterility	Nationwide
17 Aug 2022Drug	CLASS II	FentaNYL Citrate in 0.9% Sodium Chloride 1 mg per (10 mcg per mL) IV recalled	SterRx	Sterility	Nationwide

Other Sodium Bicarbonate recalls

All 34

Reported	Class	Recall	Company	Reason	Where
17 Sep 2025Drug	CLASS II	4.2% Sodium Bicarbonate Injection, USP, 5 mEq/ (0.5 mEq/mL) recalledSodium Bicarbonate	Exela Pharma Sciences	Lead & Heavy Metals	Nationwide
27 Aug 2025Drug	CLASS II	Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq recalledSodium Bicarbonate	Pfizer	Sterility	Nationwide
2 Apr 2025Drug	CLASS II	8.4% Sodium Bicarbonate Injection, USP, 50 mEq/ (1 mEq/mL) recalledSodium Bicarbonate	Exela Pharma Sciences	Sterility	Nationwide
24 Jan 2024Drug	CLASS I	8.4 % Sodium Bicarbonate Injection, USP 50 mEq/ (1 mEq/mL) recalledSodium Bicarbonate	Pfizer	Particulate Matter	Nationwide
24 Jan 2024Drug	CLASS I	4.2% Sodium Bicarbonate Injection, USP 5 mEq/ (0.5 mEq/mL) recalled	Pfizer	Particulate Matter	Nationwide