Sweetums Preservative Free Solution (Clinical Innovations) – Product Defect (2022)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Sweetums 24% sucrose solution preservative free. Vials containing 1ml or 2ml of 24% sucrose in purified water. Product is administered by drop using vials and tip allows controlled administration directly to tongue or buccal surface. Product is only used in the hospital setting including the NICU. VPSU15031250, 2mL vial, box qty 250 UPC VPSU15033250, 1mL vial, box 250 UPC VPSU15033250B, 1mL vial, individually wrapped, box qty 250 UPC 00814247020314
Brand
Clinical Innovations, LLC
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
VPSU15031250 20114a 12/12/2022 VPSU15031250 21001a 01/31/2023 VPSU15031250 21001b 01/31/2023 VPSU15031250 21004a 01/11/2023 VPSU15031250 21004b 01/31/2023 VPSU15031250 21007a 01/31/2023 VPSU15031250 21007b 01/31/2023 VPSU15031250 21007c 01/30/2023 VPSU15031250 21015a 02/28/2023 VPSU15031250 21015b 02/28/2023 VPSU15031250 21022a 02/28/2023 VPSU15031250 21040d 03/29/2023 VPSU15031250 21043a 04/13/2023 VPSU15031250 21043b 04/30/2023 VPSU15031250 21049a 04/30/2023 VPSU15031250 21049b 04/30/2023 VPSU15031250 21051a 05/31/2023 VPSU15031250 21056b 05/31/2023 VPSU15031250 21069a 06/21/2023 VPSU15031250 21081a 07/31/2023 VPSU15031250 21081b 07/31/2023 VPSU15033250 20115a 12/12/2022 VPSU15033250 21002a 01/31/2023 VPSU15033250 21006a 01/31/2023 VPSU15033250 21037a 03/31/2023 VPSU15033250 21040b 03/31/2023 VPSU15033250 21056a 05/31/2023 VPSU15033250 21062a 06/30/2023 VPSU15033250 21076a 07/31/2023 VPSU15033250 21089a 08/10/2023 VPSU15033250B 21040c 03/31/2023 VP = Was used to distinguish product for specific customers. The decision was made to consolidate the naming of the SKUs. For ease of consolidation the prefix VP was maintained. SU = SweetUms 15033 = 1 mL capacity of vial 15031 = 2 mL capacity of vial 15032 = 2 mL capacity of vial w/preservatives 250 = number of units in a box A = All lots have an A. If the product needs to be sub-lotted QA issues new paperwork for the sublot with a "B".
Clinical Innovations, LLC is recalling Sweetums 24% sucrose solution preservative free. Vials containing 1ml or 2ml of 24% sucrose in purif due to Firm received complaints of leaking, black liquid, and black particulates in the product vials.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Firm received complaints of leaking, black liquid, and black particulates in the product vials.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 6, 2026