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Unrated Drug recall · FDA · Published February 29, 2024

SSM Health Care Recalls IV Phenylephrine HCl Syringes Due to Sterility Risk

SSM Health Care recalls phenylephrine HCl syringes (NDC 60652-0104-1) with potential sterility issues. These IV drugs are for hospital/office use only and not for resale. Affected lots expire through July 2024.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0435-2024DrugSSM Health Care ›
Take action

Contact the company

Recalling firmSSM Health Care St. Louis DBA SSM St. Clare Health Center1015 Bowles Ave · Fenton, MO 63026-2394
✎ GovInfoNow plain-language explainer

SSM Health Care is recalling phenylephrine HCl syringes used in hospitals and clinics due to a lack of sterility assurance. This means the syringes could be contaminated, posing a risk of infection if used in medical procedures. Read more at govinfonow.com/recall/32789-ssm-health-care-recalls-iv-phenylephrine-hcl-syringes-due-to.

Source Summary by GovInfoNow · govinfonow.com/recall/32789-ssm-health-care-recalls-iv-phenylephrine-hcl-syringes-due-to · Updated August 17, 2026 · FDA enforcement record: FDA #D-0435-2024

Cite this page

“SSM Health Care Recalls IV Phenylephrine HCl Syringes Due to Sterility Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32789-ssm-health-care-recalls-iv-phenylephrine-hcl-syringes-due-to. Based on FDA recall #D-0435-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0435-2024%22&limit=1).

The FDA announced on Feb. 29, 2024, that SSM Health Care St. Louis DBA SSM St. Clare Health Center is recalling Phenylephrine HCl syringes due to a lack of sterility assurance. The firm did not perform process validation for the compounded drug.

How to tell if you have it

  • Brand: SSM Health Care
  • Product: Phenylephrine HCl, 1000 mcg/10 mL, 10 mL Total Volume per syringe, Intravenous, Rx Only, Hospital/Office Use Only
  • NDC: 60652-0104-1
  • Lot codes: 20240109-837CB8 (Exp. 07-Jul-2024), 20231219-08D09D (Exp. 16-Jun-2024), 20231121-20F8BB (Exp. 19-May-2024), 20231115-2FF64D (Exp. 13-May-2024), 20231101-09C52B (Exp. 29-Apr-2024), 20231010-3D0B35 (Exp. 07-Apr-2024), 20230912-847E0C (Exp. 10-Mar-2024)
  • Quantity: 11,798 syringes
  • Distribution: MO

The hazard

The recall is due to a lack of assurance of sterility because the firm did not perform process validation. The product is classified as Class II.

Context

GovInfoNow's records show SSM Health Care St. Louis DBA SSM St. Clare Health Center has 3 other recalls on record since 2017-08-10. Other recent recalls of similar products include New Life Pharma Semaglutide Injections Recall (2026-02-26), EPINEPHR: Sterility Risk in 1 mg/10mL Injection Recall (2026-04-01), and Reliance Pemetrexed Injection Recall (2026-06-24).

How to tell if you have this one

Check for the NDC code 60652-0104-1 on the syringe label. The lot numbers range from 20230912-847E0C to 20240109-837CB8 with expiration dates through July 2024.

  • Brand
    SSM Health Care
  • 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
    Ongoing
  • Distribution
    MO
Recall numberProduct, codes & lotsQuantity
D-0435-2024Phenylephrine HCl, 1000 mcg/10 mL, 10 mL Total Volume per syringe, Intravenous, Rx Only, Hospital/Office Use Only, This is a Compounded Drug - Not for Resale, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-0104-1; Lot #s: 20240109-837CB8, Exp. 07-Jul-2024; 20231219-08D09D, Exp. 16-Jun-2024; 20231121-20F8BB, Exp. 19-May-2024; 20231115-2FF64D, Exp. 13-May-2024; 20231101-09C52B, Exp. 29-Apr-2024; 20231010-3D0B35, Exp. 07-Apr-2024; 20230912-847E0C, Exp. 10-Mar-2024.11,798 syringes
D-0436-2024FentaNYL citrate, 10 mcg in 0.9% Sodium Chloride 1 mL Vial (10 mcg/mL), 1.5 mL Total Volume per Vial, Intravenous, Rx Only, Hospital/Office Use Only, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-9010-1; Lot: 20231031-0C91D9, Exo 29-Feb-2024.140 vials
Based on the official FDA remedy

What to do — step by step

  1. Check Syringe Label

    Look for the NDC code 60652-0104-1 and lot numbers listed in the recall notice.

Where it went and when

Where it was distributed

Distributed in Missouri.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: yesMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFL

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

States: Missouri.

Recall timeline

FDA published this recall 41 days after the firm started it.

1. Firm started the recall: Feb 29, 202412. FDA classified it Class II: Apr 4, 202423. Published in FDA’s Enforcement Report: Apr 10, 202432024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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

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Keep exploring

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-0435-2024 (February 29, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0435-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 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