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Stop using now Drug recall · FDA · Published July 25, 2022

SterRx recalls fentanyl IV bags due to lack of sterility assurance

SterRx recalls fentanyl IV bags (NDC 70324-327-02) with lot CHL expiring Dec 2022 due to lack of sterility assurance. Patients should not use these bags.

🇺🇸 FDA recall #D-1332-2022DrugSterRx ›
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Contact the company

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

SterRx is recalling fentanyl IV bags that may not be sterile, which could lead to infections if used. This is a serious issue for patients receiving IV fentanyl treatments. Read more at govinfonow.com/recall/34391-sterrx-recalls-fentanyl-iv-bags-due-to-lack-of-sterility.

Source Summary by GovInfoNow · govinfonow.com/recall/34391-sterrx-recalls-fentanyl-iv-bags-due-to-lack-of-sterility · Updated August 18, 2026 · FDA enforcement record: FDA #D-1332-2022

Cite this page

“SterRx recalls fentanyl IV bags due to lack of sterility assurance.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/34391-sterrx-recalls-fentanyl-iv-bags-due-to-lack-of-sterility. Based on FDA recall #D-1332-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1332-2022%22&limit=1).

The FDA announced on July 25, 2022, that SterRx, LLC voluntarily recalled fentaNYL Citrate IV bags due to a lack of assurance of sterility. The recall affects 360 bags distributed nationwide.

How to tell if you have it

  • Brand: SterRx
  • Product: fentaNYL Citrate in 0.9% Sodium Chloride, 2.5 mg per 250 mL, (10 mcg per mL) IV bags
  • NDC: 70324-327-02
  • Lot #: CHL
  • Exp. Date: Dec 29, 2022

The hazard

The recall was issued because the product lacks assurance of sterility. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show SterRx, LLC has three other recalls on record since August 10, 2021. Other recent recalls of similar products include SterRx Norepinephrine 250mL Bags Recall (July 7, 2023), SterRx Fentanyl Injection Recall (November 12, 2021), and SterRx Sodium Bicarbonate Dextrose Injection Recall (August 10, 2021). Other recent recalls of similar products include Reliance Pemetrexed Injection Recall (June 24, 2026) and ProRx recalls Tirz (October 15, 2025) and Semaglutide Injection Recall (October 15, 2025).

How to tell if you have this one

Check for the NDC code 70324-327-02, lot number CHL, and expiration date December 29, 2022. The product is sold by SterRx in Plattsburgh, NY.

  • 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.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    Nationwide within the United States
Recall numberProduct, codes & lotsQuantity
D-1331-2022FentaNYL Citrate in 0.9% Sodium Chloride 1 mg per 100 mL (10 mcg per mL) IV bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903, NDC 70324-327-01.; Lot #: CHI, Exp. Date Dec 22, 2022720 bags
D-1332-2022fentaNYL Citrate in 0.9% Sodium Chloride, 2.5 mg per 250 mL, (10 mcg per mL) IV bags, Rx Only, SterRx, 141 Idaho Avenue, Plattsburgh, NY 12903, NDC 70324-327-02.; Lot #: CHL, Exp. Date Dec 29, 2022360 bags
Based on the official FDA remedy

What to do — step by step

  1. Stop using it now

    Immediately discard the recalled fentanyl IV bags if you have them.

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 within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 11 months after the firm started it.

1. Firm started the recall: Jul 25, 202212. FDA classified it Class II: Aug 9, 202223. Published in FDA’s Enforcement Report: Aug 17, 202234. FDA terminated the recall: Jun 22, 2023420222023
  1. Firm started the recall
  2. FDA classified it Class II
  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.

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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-1332-2022 (July 25, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1332-2022 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