A subsidiary of Indian drugmaker Hetero Group mistakenly packaged two types of antidepressants in packs of sertraline, potentially posing risks to patients.
Amarox is recalling one batch of sertraline after packaging a blister strip of another antidepressant in the same carton.
The recall affects a batch of 100 mg film-coated tablets of the selective serotonin reuptake inhibitor (SSRI) sertraline, the UK Medicines and Healthcare products Regulatory Agency (MHRA) said in an April 28 press release. A complaint by a patient led Amarox to realize it had included a blister strip of citalopram—a different SSRI sold as Celexa—inside the sealed cartons of sertraline.
Amarox, a wholly owned subsidiary of the Indian drugmaker Hetero Group, manufactures sertraline and citalopram at the same facility. The error appears to have occurred during secondary packaging of the blister strips into the cartons, the MHRA said.
Healthcare professionals should quarantine all remaining stock and return it to their supplier, according to the agency. The MHRA wants pharmacists to contact all patients who have received the recalled product, either by identifying them using product traceability information or by finding everyone who received the product on or after Nov. 28, 2025.
Pharmacists should prioritize patients who received packs in the past 28 days, the MHRA said. Because most of the recalled batch was distributed last year, the agency expects that many of the packs have been dispensed to patients and consumed. Patients should return any remaining stock.
The patient who filed the complaint reported experiencing a headache. The headache resolved after the patient stopped taking the drug, the MHRA said, but in susceptible individuals “concurrent exposure to two SSRIs may carry a risk of more pronounced serotonergic effects.”
Healthcare professionals should tell patients who may have inadvertently ingested citalopram instead of or in addition to sertraline that they may experience increased serotonergic effects, the MHRA said. The agency expects healthcare professionals to contact patients to review their treatment and whether a new prescription is required for ongoing resupply.
Patients who have pre-existing cardiac conditions, are older than 65 years or are taking concomitant serotonergic or QT-prolonging medication are at higher risk, the MHRA said. Co-administration of sertraline with serotonergic drugs is avoided when possible because of the risk of a pharmacodynamic interaction, according to the product label. The label lists QT prolongation, a cardiac adverse event, as a risk.
A healthcare professional may need to monitor patients who received the recalled batch and are over 65 or under 18 years old or have cardiac or liver conditions, the MHRA said. Patients who are predicted to be poor metabolizers of CYP2C19 substrates, meaning that they process certain medicines differently, may also require monitoring, according to the agency.
