Behind the Recall – Week 52
This week’s recalls weren’t driven by exotic hazards. They came from everyday breakdowns, storage conditions, labeling execution, sanitation discipline, and pathogen findings that were caught after the fact.
If you’re an operations leader, these are the kinds of failures that hurt twice:
- They disrupt throughput (holds, rework, line stops, changeovers, investigations)
- They elevate enterprise risk (regulatory exposure, customer loss, legal and brand impact)
The good news: these are preventable, with stronger end-to-end controls.
What These Recalls Signal
A few patterns stood out:
1) Storage and handling can become the hazard.
Facility conditions and pest activity are not “support” issues, they’re product risk.
2) Labels and allergens are still failing at the point of execution.
Most companies have procedures. The misses happen during changeovers, reprints, staging, and release.
3) Pathogens are still being found by regulators and external testing.
That’s a sign that your internal detection and escalation system isn’t strong enough or isn’t being used.
4) Supplier and co-manufacturer risk becomes your brand risk instantly.
Even if it didn’t start in your plant, you still own the outcome.
Operations-Driven Recall Prevention Tips
These aren’t “quality tips.” They’re how strong operators run plants that perform and stay out of trouble.
1) Treat Warehouses Like Production
If you store it, you own it.
- Put storage areas on the same GMP/sanitation cadence as production
- Trend pest activity and corrective actions
- Require documented pre-op acceptability for any staged ingredients/packaging
2) Build Label Control into the Line
Most label failures happen during speed, pressure, and routine.
- Use two-step verification at every changeover
- Control label staging so the wrong label can’t physically reach the line
- Make reprint controls tight (approval, reconciliation, scrap accountability)
3) Strengthen Environmental Monitoring as an Operations KPI
If your EMP isn’t driving action, it’s just sampling.
- Validate zones, sites, and frequency based on real traffic
- Trend by area and shift to spot repeat patterns early
- Escalate positives like downtime events: contain → investigate → fix → verify
4) Make “Complaint Readiness” a Leadership Standard
Complaints are often the first signal that internal detection didn’t work.
- Train teams on how to recognize and escalate foreign material and allergen risk fast
- Run short, realistic drills: “consumer complaint → injury risk → decision path”
- Require leadership floor presence focused on: sanitation, label staging, and line discipline
5) Audit Your Co-Manufacturer Like It’s Your Plant
If they make it, you own it.
- Review their environmental monitoring program (trending, escalation, CAPA closure)
- Verify sanitation effectiveness with observation and records, not paperwork alone
- Confirm their changeover and label controls match your risk tolerance
If you want support assessing your supplier/co-manufacturer controls, strengthening your EMP, or tightening label execution, contact me at info@manningresource.com.
December 21, 2025 – December 28, 2025 – 9 Recalls (8 FDA, 1 USDA)
Current Class 1 FDA & USDA Recall Trends
FDA
Recalls / Reason(s)
- 12/26/25 – Animal & Veterinary – All FDA-regulated products held at facility including drugs, medical devices, cosmetics, dietary supplements, human food, and pet food – Potential Salmonella contamination, presence of rodent and avian contamination and insanitary conditions during the storage process.
- “Products held under insanitary conditions may become contaminated through contact with contaminated surfaces or exposure to airborne particulates associated with animal waste.” 1
- 12/24/25 – Animal & Veterinary – Dog Biscuits – Potential to be contaminated with Salmonella.
- “The recall was the result of a routine sampling program by the FDA which revealed that the finished products contained the bacteria. The company has ceased the production and distribution of the lot number as FDA and the company continue their investigation as to what caused the problem.” 2
- 12/23/25 – Food & Beverage – Almond Despair chocolate bar – Potential or Undeclared Allergen – Almond.
- “The ingredient statement incorrectly identifies macadamia nuts as present in the product.” 3
- 12/23/25 – Food & Beverage – Holiday Bark – Undeclared pecans and wheat.
- “The expanded recall was initiated after it was discovered that the Pecan, Cranberry & Cinnamon Holiday Bark had been packaged in Cookie Butter Holiday Bark packages resulting in undeclared pecan. Subsequent investigation indicates the problem may have been caused by a temporary breakdown in the company’s production and packaging process.” 4
- 12/23/25 – Food & Beverage – Cookie tins – Undeclared tree nut allergens, almonds, pecans, and walnuts.
- “The recall was voluntarily initiated after it was discovered that the product containing almonds, pecans, and walnuts was distributed in packaging that did not reveal the presence of the nut allergen. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company’s labeling process.” 5
- 12/23/25 – Food & Beverage – Bag Full of Cookies White Chocolate Macadamia Nut Frozen Cookie Dough – Undeclared peanuts.
- “The recall was initiated after it was discovered that the peanut-containing product was distributed in packaging that did not reveal the presence of peanuts.” 6
- 12/22/25 – Drugs – Rheumacare Capsules – Elevated levels of lead.
- “Handelnine Global Limited d/b/a Navafresh is voluntarily recalling Lot Numbers CAM040 & CALO79-N of Rheumacare Capsules by Virgo UAP Pharma Pvt. Ltd. (Virgo) to the consumer level. In test conducted by the Food and Drug Administration the product has been found to contain lead at levels up to 11,100 ppm, which are higher than permissible levels.” 7
- 12/22/25 – Food & Beverage – Pfeffernusse Cookies – Undeclared milk, wheat, and soy allergens.
- “This missing labeling was revealed during routine inspections. Subsequent investigation indicates missing labels were a cause of human error.” 8
USDA
- 12/27/25 – Food – Ground Beef Products – Possible E. coli 026 Contamination.
- “The problem was discovered during routine FSIS testing and the sampling results showed the presence of coli O26.” 9
#FoodSafety #FoodManufacturing #OperationsLeadership #OperationalExcellence #QualitySystems #RecallPrevention #RiskManagement #EnvironmentalMonitoring #SupplierQuality #CoManufacturing #LabelControl #AllergenControl #PestControl #FSMA #ContinuousImprovement #PrivateEquity #DueDiligence #PlantManagement #Manufacturing
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