Well-known Pfizer high blood pressure drug is recalled in Spain

The Spanish Agency for Medicines and Health Products has 'detected a quantity of impurities greater than those allowed' in the medication


The Spanish Agency for Medicines and Health Products (Aemps) has issued a recall notice on its website for a well-known drug from the Pfizer laboratory prescribed to treat patients with hypertension or high blood pressure.

The warning specifically affects three presentations of Acuprel, a drug belonging to the group called angiotensin-converting enzyme (ACE) inhibitors, from the group of antihypertensives that act by dilating blood vessels in the body.

Acuprel is often prescribed for the treatment of patients with high blood pressure (hypertension) and patients with chronic heart failure.

Aemps has urged the recall of all the distributed units of the affected batches and their return to the laboratory through the usual channels.

The problem defected? "An impurity above its established limit," says the Aemps alert.

The affected presentations and the batches linked to said health warning are:

Acurel 20 mg film-coated tablets, 28 tablets (NR: 59082, CN: 725150)

- Batch: DT1726, expiration date 04/30/2023

- Batch: EP6755, expiration date 09/30/2023

- Lot: FF8049, expiration date 09/30/2023

- Lot: FJ7223, expiration date 09/30/2023

- Lot: FM6653, expiration date 09/30/2023

Acurel 40 mg film-coated tablets, 28 tablets (NR: 61710, CN: 667964)

- Batch: CY1994, expiration date 09/30/2022

- Batch: DT1722, expiration date 09/30/2022

- Batch: EM1564, expiration date 12/31/2022

- Batch: FA3732, expiration date 12/31/2022

- Lot: FJ1093, expiration date 04/30/2024

Acurel 5 mg film-coated tablets, 60 tablets (NR: 59081, CN: 731919)

- Lot: FF2036, expiration date 05/31/2024

The Spanish Agency for Medicines and Health Products has also asked that if anyone has any of the affected batches at home, they should take it to their nearest pharmacy so that it can be returned to the laboratory and be reimbursed the amount of the medicine.