Temperature Monitoring Monthly
When the cold chain fails, where does the failure actually happen?
Three significant temperature-related recalls in September highlight a recurring problem across food and pharmaceuticals:
The product may be perfectly acceptable when it leaves the manufacturer. The risk can be introduced later.
In the US, TerSera Therapeutics recalled 296 cartons of Zoladex (goserelin) 3.6 mg after the product spent 25.5 hours in a non-temperature-controlled FedEx trailer under ambient outdoor conditions. The FDA classified the reason for the recall as “Temperature Abuse”. The published information identifies the transport conditions but does not provide the actual temperatures reached or indicate that a monitoring alarm triggered the event. [FDA / TerSera Zoladex recall record]
In Canada, Sanofi recalled selected insulin pens and cartridges after affected units may have been frozen during shipping. Health Canada reported 1,043 affected units distributed to around 80 pharmacies, clinics and hospitals. [Health Canada — Sanofi insulin recall] A separate recall involved nine Sarclisa vials in Nova Scotia, again because the product may have been frozen during shipment. In both cases, the issue was not excessive heat but the opposite: an excursion below the product's permitted temperature range. Health Canada noted that frozen insulin may have reduced effectiveness. [Health Canada — Sarclisa recall]
And in the UK, Waitrose recalled its Essential Unsweetened Oat Drink following a breakdown in temperature control, creating a risk of microbiological contamination and spoilage. The recall covered one-litre packs with best-before dates from 14 August to 29 October 2026, purchased between 2 and 21 September. [UK FSA / Waitrose oat drink recall]
Different products. Different markets. Different temperature requirement
But the underlying lesson is remarkably similar:
A temperature specification isn't the same thing as temperature monitoring.
A specification tells us where a product should be.
Monitoring tells us where it actually was.
And, critically, it can tell us what happened between those two points.
Was the product continuously monitored?
Was an excursion detected?
Was an alarm generated?
Did somebody respond?
How long was the product outside its permitted range?
Can the affected batch or shipment be identified?
And can the temperature history be produced as evidence?
These questions become particularly important as products pass through multiple organisations — manufacturer, warehouse, carrier, distribution centre and ultimately the customer. Responsibility may change hands several times, but the product's temperature history does not.
The cold chain is often described as a physical journey.
Increasingly, it also needs to be an evidenced journey.
The incidents highlighted this month are a useful reminder that temperature monitoring isn't simply about proving that a product arrived at the right temperature. It is about having reliable evidence that it remained within its required temperature range throughout the journey — and knowing what happened when it didn't.
For organisations handling temperature-sensitive products, that distinction can be the difference between discovering a problem and being able to prevent, contain and investigate one.
About Temperature Monitoring Monthly
Temperature Monitoring Monthly is Signatrol's editorial briefing on temperature monitoring, cold-chain integrity and temperature-sensitive supply chains. Each edition looks at real-world incidents and the practical lessons they offer for manufacturers, distributors, logistics providers and other organisations handling temperature-sensitive products
Sources: FDA, Health Canada, UK Food Standards Agency and other cited regulatory and industry sources.
Published: 2 October 2026
