Vanilla Econo, Galletas de Vainilla, 8 paquets per Net Wt. 9.6 oz box (272 g), 6 box per…
Rovira Biscuit Corporation recalled this product and the FDA reported the enforcement action on 14 January 2026 as Class II. The recall was initiated by the firm. Undeclared colors FD&C Yellow #6, and FD&C Red 40
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
- Vanilla Econo, Galletas de Vainilla, 8 paquets per Net Wt. 9.6 oz box (272 g), 6 box per case. UPC 072981005022
- UPC
- 072981005022
- Reason for recall
- Undeclared colors FD&C Yellow #6, and FD&C Red 40
- Recalling firm
- Rovira Biscuit Corporation
- Firm location
- Ponce, Puerto Rico, United States
- Classification
- Class II
- Status
- Terminated
- Recall number
- H-0360-2026
- Quantity
- 22,114 units
- Distribution
- GA, TX, MA, IL, MD, USVI and Puerto Rico. Foreign Panama and BVI
- Initiated
- 17 December 2025
- Reported by FDA
- 14 January 2026
- Terminated
- 7 April 2026
- Firm notified by
- Product codes
- Lot numbers: 11625 12725 21325 40725 50625 52625 60925 71525 80425 91624 91825 92925 103025 111124 111325 112524 121624 062425
Reading this record
Five things about this record are not in the record itself, and each one changes how it should be read.
- Class II means the FDA judged a remote probability of serious harm, or a probability of temporary or medically reversible harm. 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 is one of 6 records covering the same recall event. The FDA opens one enforcement record per product code, so a recall of a product line appears here many times. Counting these records as 6 separate recalls, which almost every published figure does, overstates it by a factor of 6. Every product code in this event is listed together on the record that covers the whole recall, which is the page a search engine is pointed to for all 6 of them.
- The recall ran for 4 months, from 17 December 2025 to termination on 7 April 2026. 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 5 states, and the FDA published the enforcement report 4 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: Georgia, Texas, Massachusetts, Illinois, Maryland. 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
Undeclared allergens
An undeclared allergen recall means a food contained one of the major allergens and the label did not say so, either because the wrong label was applied or because an ingredient carried an allergen nobody traced.
A preventive controls plan covers an undeclared allergen 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 117.135(c)(2)
- Food allergen controls: the written preventive controls that keep an allergen out of a food it does not belong in, and that get the allergens present onto the label.
- 21 CFR 101.4
- Ingredient declaration: every ingredient listed by its common name, in descending order of predominance, on the label of a packaged food.
- 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 Rovira Biscuit Corporation
The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 5 other records name this firm.
All 6 records for Rovira Biscuit Corporation
All 2026 recalls · All FDA food recall data
21 CFR 117.135(c)(2) 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.