The US Food and Drug Administration (FDA) has triggered its most urgent level of recall after discovering a potentially deadly error in the packaging of over-the-counter pain relief medication.
The alert, classified as a Class I recall, signifies a 'reasonable probability' that the product could cause severe health complications or death.
What is the danger?
The recalled product, labelled as IBUPROFEN capsules, was incorrectly packaged. Consumers purchasing what they believe to be the common painkiller ibuprofen may instead find themselves taking a completely different drug: acetaminophen, also known as paracetamol.
This mislabelling poses a critical risk for individuals with a severe allergy to acetaminophen, who could suffer a life-threatening anaphylactic reaction after taking the capsule, believing it to be a safe alternative.
Which products are affected?
The recall specifically targets one lot of IBUPROFEN CAPSULES 200MG distributed by the brand Cumberland Pharmaceuticals. The affected lot is:
- Lot Number: 200648
- Expiration Date: December 2025
- NDC Number: 68682-101-01
The capsules are packaged in white plastic bottles containing 90 capsules each.
What should you do?
If you have this specific lot of medication in your home, the FDA advises you to:
- Stop using the product immediately.
- Check the lot number on your bottle to confirm it is part of the recall.
- Return the product to the place of purchase or dispose of it safely, out of reach of children and pets.
- Consult your GP or a pharmacist if you have taken the medication and have any health concerns, especially if you have a known acetaminophen/paracetamol allergy.
While no adverse events have been reported to date, the FDA and Cumberland Pharmaceuticals are acting with extreme caution due to the grave potential consequences of this packaging error. Consumers are urged to remain vigilant and check their medicine cabinets.
