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Stop using now Drug recall · FDA · Published August 10, 2021

SterRx Sodium Bicarbonate Dextrose Injection Recall: Non-Sterility Risk

SterRx recalls 1,000 mL Sodium Bicarbonate in 5% Dextrose Injection bags due to microbial contamination. This poses a non-sterility hazard requiring immediate action.

🇺🇸 FDA recall #D-0767-2021DrugSterRx ›
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Contact the company

Recalling firmSterRx, LLC141 Idaho Ave · Plattsburgh, NY 12903-3987
✎ GovInfoNow plain-language explainer

SterRx is recalling 1,000 mL bags of Sodium Bicarbonate in 5% Dextrose Injection (150 mEq per 1,000 mL) because a third-party lab found microbial contamination. Using this product could lead to infection or other health risks if it's not sterile. Read more at govinfonow.com/recall/35984-sterrx-sodium-bicarbonate-dextrose-injection-recall-non-sterility-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/35984-sterrx-sodium-bicarbonate-dextrose-injection-recall-non-sterility-risk · Updated August 18, 2026 · FDA enforcement record: FDA #D-0767-2021

Cite this page

“SterRx Sodium Bicarbonate Dextrose Injection Recall: Non-Sterility Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35984-sterrx-sodium-bicarbonate-dextrose-injection-recall-non-sterility-risk. Based on FDA recall #D-0767-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0767-2021%22&limit=1).

The FDA announced on August 10, 2021, that SterRx, LLC voluntarily recalled Sodium Bicarbonate in 5% Dextrose Injection due to non-sterility confirmed by a third-party lab. The recall affects 1,098 bags distributed nationwide.

How to tell if you have it

  • Brand: SterRx
  • Product: Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL bags
  • NDC: 70324-326-01
  • Lot Number: BUP
  • Expiration Date: 03/23/22

The hazard

The firm's third-party lab confirmed microbial contamination in the product. This non-sterility hazard led to a Class I recall classification.

Context

GovInfoNow's records show SterRx, LLC has issued three other recalls since November 12, 2021, including Norepinephrine and Fentanyl IV bags lacking sterility assurance. Other recent recalls of similar products include Fresenius Kabi 1000mL Sodium Chloride Injection (March 11, 2026), Fresenius Kabi 0.9% Sodium Chloride Injection (March 11, 2026), and Fresenius Kabi 5% Dextrose Injection (March 11, 2026).

How to tell if you have this one

Check for the product name 'Sodium Bicarbonate in 5% Dextrose Injection', 150 mEq per 1,000 mL, 1,000 mL bags. The lot number is BUP with an expiration date of March 23, 2022.

  • Brand
    SterRx
  • Category
    Drug
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Status
    Terminated
  • Distribution
    Nationwide in the US
Recall numberProduct, codes & lotsQuantityClass
D-0767-2021Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903 NDC 70324-326-01; Lot Number: BUP, exp. date 03/23/221098 bagsClass I
D-0768-2021Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903; Lot Numbers: BTW, exp. date 03/08/22 BUI, exp. date 03/16/223378 bagsClass II
Based on the official FDA remedy

What to do — step by step

  1. Stop Using Now

    Immediately discard the product if you have it.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide in the US” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 9 months after the firm started it.

1. Firm started the recall: Aug 10, 202112. FDA classified it Class I: Aug 25, 202123. Published in FDA’s Enforcement Report: Sep 1, 202134. FDA terminated the recall: May 19, 2022420212022
  1. Firm started the recall
  2. FDA classified it Class I
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

What should I do if I have this product?

Discard it immediately and contact your healthcare provider for alternative options.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0767-2021 (August 10, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0767-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA