The UK’s Medicines and Healthcare products Regulatory Agency has recalled a batch of Sertraline 100 mg tablets after discovering the packs may actually contain Citalopram, a different antidepressant. The Class 2 recall, issued under reference EL(26)A/22 in April 2026, names Amarox Limited as the marketing authorization holder and warns pharmacies to pull the affected stock immediately and contact any patient who may have received it.
Both Sertraline and Citalopram are selective serotonin reuptake inhibitors (SSRIs) used to treat depression and anxiety, but they are not interchangeable. They differ in active ingredient, dose range, drug interactions, and contraindications. A patient unknowingly switched from one to the other could face withdrawal effects from the missing drug, unexpected side effects from the substitute, or a dangerous buildup of serotonin if the two overlap in the body.
Why the recall matters for patients
Under the MHRA’s classification system, a Class 2 recall indicates that the affected product “could cause illness or mistreatment, but is not expected to be life-threatening,” according to the agency’s published recall guidance. That designation still triggers a mandatory return from pharmacies and wholesalers and places a legal obligation on dispensing professionals to trace and notify patients.
The most serious clinical concern is serotonin syndrome, a condition that can develop when serotonin levels spike because of overlapping or mismatched SSRI exposure. Symptoms include agitation, rapid heart rate, high blood pressure, muscle twitching, and, according to the NHS, seizures or loss of consciousness in severe cases. Even short of that extreme, receiving the wrong antidepressant can destabilize a patient’s mental health at a point when consistent treatment matters most.
What is still unknown
The MHRA’s recall notice confirms the product, the manufacturer, and the nature of the problem, but several key details remain outstanding. The specific batch number or numbers and their expiry dates have not been included in the publicly available materials reviewed for this report. Those identifiers are the critical details patients need to check their own medication packaging, and anyone taking Sertraline 100 mg from Amarox Limited who cannot locate batch information in the MHRA’s online alert should contact their pharmacist directly.
Amarox Limited has not publicly explained how Citalopram tablets entered a Sertraline production or packaging line. Whether the error occurred during manufacturing, packaging, or distribution has not been disclosed.
It is also unclear how many patients may have already taken tablets from the affected batch. The MHRA’s Yellow Card reporting system collects adverse-reaction reports from patients and healthcare professionals, but no specific count of incidents linked to this batch has been published. Without that data, the real-world impact of the mix-up cannot yet be measured.
Whether the entire batch contained Citalopram or only a portion of the tablets were affected has not been confirmed. A partial contamination would mean some patients received the correct Sertraline while others did not, making it harder to trace outcomes. The geographic scope of distribution has not been detailed in the public notice either.
Regulatory follow-up actions, such as a formal inspection of Amarox Limited’s facilities or a review of the company’s manufacturing license, typically come after the recall process concludes. The MHRA has not announced a timeline for those steps.
What patients and pharmacists should do now
Anyone currently taking Sertraline 100 mg tablets supplied by Amarox Limited should check the batch number printed on their medication packaging against the details in the MHRA’s alert. If the batch matches, or if there is any doubt, patients should contact their pharmacist or prescribing doctor straight away.
Crucially, patients should not stop taking antidepressant medication abruptly without medical guidance. Sudden SSRI withdrawal can cause dizziness, nausea, irritability, and rebound depression. A healthcare provider can verify whether the tablets are correct and, if they are not, arrange a safe switch back to the intended medication.
Pharmacists who dispensed Sertraline 100 mg from Amarox Limited should cross-reference their stock records against the recalled batch and proactively reach out to affected patients. The MHRA’s recall framework places that responsibility on the dispensing pharmacy, and failure to act on a Class 2 recall can carry regulatory consequences.
How to report a suspected adverse reaction
Patients or professionals who suspect they have experienced a side effect linked to this batch can file a report through the MHRA’s Yellow Card scheme online or by calling the agency directly. Those reports feed into the MHRA’s ongoing safety monitoring and help determine whether further action is needed.
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*This article was researched with the help of AI, with human editors creating the final content.
