UDK ,Half Plum, 170 g, Container, 24, ambient
SUNGAL INC recalled this product and the FDA reported the enforcement action on 1 October 2025 as Class III. The recall was initiated by the firm. Cyclamate adulteration
The record
Every field below is published by the FDA in the openFDA food enforcement database. Check the FDA notice before acting on any recall: this page is a reading of the public record, not a substitute for it.
- Product
- UDK ,Half Plum, 170 g, Container, 24, ambient
- Reason for recall
- Cyclamate adulteration
- Recalling firm
- SUNGAL INC
- Firm location
- Kearny, New Jersey, United States
- Classification
- Class III
- Status
- Terminated
- Recall number
- H-0636-2025
- Quantity
- 29 CASES
- Distribution
- The adulterated product was distributed to the following states: CA, MD, NY, VA
- Initiated
- 8 August 2025
- Reported by FDA
- 1 October 2025
- Terminated
- 8 December 2025
- Firm notified by
- Product codes
- code 2024 12 15 2 UPC 9588837778794
Reading this record
Five things about this record are not in the record itself, and each one changes how it should be read.
- Class III means the FDA judged that the product was unlikely to cause harm but violated FDA labelling or manufacturing regulation. The class is assigned by an agency health hazard evaluation under 21 CFR 7.41, not by the firm.
- The firm started this recall itself. Most FDA food recalls are voluntary, and a recall is a food safety plan working rather than failing. The circumstances in which the agency asks for one instead are set out in 21 CFR 7.45.
- This record is the only one the FDA opened for its recall event, so it covers a single product code.
- The recall ran for 4 months, from 8 August 2025 to termination on 8 December 2025. Termination means the agency judged that all reasonable effort had been made, under 21 CFR 7.55, and it says nothing about whether product remained in circulation.
- The distribution pattern names 3 states, and the FDA published the enforcement report 8 weeks after the firm began the recall.
- The product description on this record names no food this site can classify, so it appears on no food-type page. That is a limit of the description rather than of the recall.
Named in the distribution pattern: Maryland, New York, Virginia. Those pages count recalls by where the RECALLING FIRM sits, which is a different question from where this product went.
What this recall was for
Unapproved ingredients
An unapproved ingredient recall means a product contained a substance not permitted in food, most often an undisclosed pharmaceutical active found in a dietary supplement.
A preventive controls plan covers an unapproved ingredient under the clauses below. This is where the control belongs, not a finding against any firm named on this page: a recall record states a reason, and most of these recalls were initiated by the firm itself.
- 21 CFR 111
- Dietary supplement CGMP: the identity, purity, strength and composition specifications a supplement manufacturer sets and verifies for every component and finished batch.
- 21 CFR 117 subpart G
- Supply-chain programme: the approval and verification a receiving facility runs on a supplier when the hazard is controlled before the ingredient arrives.
Other records from SUNGAL INC
The FDA opens one enforcement record per product code, so several of these are frequently one recall event.
| Reported | Product | Firm | Reason | Class |
|---|---|---|---|---|
| 2026-05-13 | XZL, Jelly Snacks, 12.68 OZ, Bag. 12 Bags per Case. | SUNGAL INC | Product Contains undeclared FD&C Yellow #5 & #6 and Red #40 | Class II |
All 2025 recalls · All FDA food recall data
21 CFR 111 is the clause behind this recall, and it is one somebody has to produce evidence for at their next audit. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.
Early accessRecall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.