MHRA Class 2 medicine recalls – May/June 2025

The Medicines and Healthcare Products regulatory agency (MHRA) has issued another Class 2 recall, bringing the total number of pharmaceutical products given this classification in the past month to three. 

The agency defines Class 2 as a major defect. While not life-threatening, recall action must be taken within 48 hours.

Recall due to packaging error

Inhixa

The latest medicine to be given this classification (drug alert number: EL(25)A/27) is the injectable solution Inhixa 12,000IU (120mg)/0.8mL. The MHRA issued this recall on 12 June to the Marketing Authorisation Holder (MAH) Quadrant Pharmaceuticals Limited/Maxearn Limited.

The MAH reported a typographical error on the carton. According to Maxearn, two erroneous parallel imported batches have entered the market. Approximately 14 defective packs (each containing 10 prefilled syringes) were released to pharmacies.

Specifically, the packaging stated an incorrect product strength on one side of the carton: “12,000 IU (20mg)/0.8 ml solution for injection” instead of the correct strength “12,000 IU (120mg)/0.8 ml solution for injection”.

Recall due to microbial contamination

Mercaptopurine

On 22 May, the MHRA issued a Class 2 recall for MAH Aspen Pharma Trading Limited’s Mercaptopurine 50mg tablets (drug alert number: EL (25)A/23).

As a precautionary measure, the MAH recalled a specific batch of the oral medicine due to microbial contamination due to Penicillium Kongii. This was found by healthcare professionals who reported some discoloured tablets within the packs, according to Aspen Pharma.

BD ChloraPrep Clear – 1mL Applicator

The MHRA issued a Class 2 recall on 19 May for Becton Dickinson UK Ltd’s BD ChloraPrep Clear – 1mL Applicator (drug alert number: EL(25)A/22). 

The MAH notified the agency that “some units exhibit an open seal on the packaging of the applicator”.

Similarly, the recall has been actioned as a precautionary measure to mitigate further potential risk of pathogenic contamination, which could increase rates of infections in patients.

The exact number of affected units in each batch “is unknown”, according to Becton Dickinson.

Last month, the MHRA issued two other recalls for medicines, both Class 4. It remains to be seen which products, if any, will receive such notifications in the remainder of June.