The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has recalled a batch of sertraline 100 mg film-coated tablets manufactured by Amarox Limited after a packaging error led to citalopram 40 mg blister strips being enclosed within sealed cartons of the product.
The class two recall, published on 28 April 2026, affects batch number V2500425 and was triggered by a patient complaint.
The error is believed to have occurred during secondary packaging, when blister strips from two different products were incorrectly combined into single cartons.
Both sertraline and citalopram are selective serotonin reuptake inhibitors (SSRIs) manufactured by Amarox (a subsidiary of Indian drugmaker Hetero Group) at the same production facility.
The affected batch was first distributed on 28 November 2025 and the MHRA has noted that the majority of the stock is likely to have already been dispensed and consumed.
Pharmacists are instructed to immediately cease supply of the batch, quarantine all remaining stock and return it to their supplier. Pharmacy teams are asked to prioritise contacting patients who received the product within the last 28 days, using product traceability data where available.
Healthcare professionals are advised to contact the relevant GP or responsible clinician to review treatment and assess whether a new prescription is required for continued supply. Any suspected adverse reactions should be reported via the MHRA Yellow Card scheme.
Industry response
The recall has prompted calls from within the pharmacy sector for manufacturers to reimburse community pharmacies for time spent managing product withdrawals.
Henry Gregg, Chief Executive of the National Pharmacy Association, said that hard-pressed pharmacy teams should not bear the operational costs of recalls beyond their control.
"This has potentially serious consequences for patients and is deeply frustrating for pharmacies."
Pharmacies, who bare the brunt of any recall, should be reimbursed for the cost of these mistakes by the manufacturers who make them.
Prescribers, dispensers and medicines supply chain professionals can find full guidance, including the batch number and product details, in the MHRA's published recall notice.