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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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High RiskFDA Food
Food & Beverages/Packaged & Processed

Sweetums 24% Sucrose Solution Recalled for Contamination and Leaking Cups

Agency Publication Date: August 31, 2022
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Summary

Clinical Innovations, LLC is recalling 1,773 boxes of Sweetums 24% Sucrose Solution Preservative Free 15 mL cups because the firm received reports of leaking cups, black liquid, and black particulates within the solution. This product is used specifically in hospital settings, including Neonatal Intensive Care Units (NICU), and is administered directly to an infant's tongue or inner cheek. While no injuries or illnesses have been reported to date, the presence of foreign material or compromised packaging indicates a potential health risk to vulnerable patients. Medical professionals should immediately stop using the affected lots and contact the manufacturer for return instructions.

Risk

The presence of unidentified black liquid or particles and leaking containers suggests a failure in the aseptic packaging process and potential contamination. This poses a significant risk of infection or harm to neonatal patients who receive the solution directly on sensitive oral surfaces.

What You Should Do

  1. This recall affects Sweetums 24% Sucrose Solution Preservative Free (Catalog Number VPSU15037288) packaged in 15 mL cups with foil lids, sold in boxes of 288 cups.
  2. Check the packaging for lot numbers 21222, 21223, 21224, 21225, 21235, 21236, 21250, 21251, 21252, 21254, 21312, 21314, 21315, 21316, 21319, 21320, 21321, 21322, 21323, or 21326. See the Affected Products section below for the full list of affected codes and expiration dates.
  3. Stop using the recalled product immediately and contact Clinical Innovations, LLC or your medical supply distributor to arrange for the return of any remaining stock.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls for more information.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact the manufacturer or your clinical distributor to arrange for a return and full refund for any unused boxes of the affected solution.
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Dispose of any opened or affected product according to standard hospital protocols for contaminated medical supplies.

Affected Products

Product: Sweetums 24% Sucrose Solution Preservative Free (15 mL cups)
Variants: Preservative Free, 15 mL cups, Box of 288
Item Code:
VPSU15037288
UPC Codes:
814247020673
Lot Numbers:
21222 (Exp 08/10/2022)
21223 (Exp 08/11/2022)
21224 (Exp 08/12/2022)
21225 (Exp 08/13/2022)
21235 (Exp 08/23/2022)
21236 (Exp 08/24/2022)
21250 (Exp 09/07/2022)
21251 (Exp 09/08/2022)
21252 (Exp 09/09/2022)
21254 (Exp 09/11/2022)
21312 (Exp 11/08/2022)
21314 (Exp 11/10/2022)
21315 (Exp 11/11/2022)
21316 (Exp 11/12/2022)
21319 (Exp 11/15/2022)
21320 (Exp 11/16/2022)
21321 (Exp 11/17/2022)
21322 (Exp 11/18/2022)
21323 (Exp 11/19/2022)
21326 (Exp 11/22/2022)
GTIN:
00814247020673

Product is aseptically packaged in 15 mL cups with foil lid. Cup is latex-free, DEHP-free, and BPA-free. Intended for use in NICU settings.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90636
Status: Resolved
Manufacturer: Clinical Innovations, LLC
Sold By: Hospitals; Neonatal Intensive Care Units (NICU)
Manufactured In: United States
Units Affected: 1,773 boxes (288 cups/box)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.