When the Food and Drug Administration (“FDA”) considers a drug to be in violation of its regulations, it may order a recall to remove the product from the market. The defect may be in the product itself, in the product labeling, or in promotional literature for the product. Approximately 4,500 drugs and medical devices are recalled each year.
Will someone notify me of a recall?
Yes. There are several methods of notifying wholesalers & retailers, physicians, pharmacies, and patients of drug recalls. Drug manufacturers work with the FDA to conduct recalls, but manufacturers are responsible for notifying doctors and hospitals. Patients may find out about a recall in several ways:
- Drug manufacturer or the FDA or pharmacy will notify patients by phone, email or letter
- Pharmacy or physician will notify patients by phone, email or letter
- Drug manufacturer posts recall information on its website
- FDA publicly announces the recall in the media
FDA databases: FDA publishes a weekly Enforcement Report that contains all recalls. It also maintains a searchable list of recalled drugs: (Drug Recalls | FDA)
How do I know how dangerous the recalled drug is?
There are three recall classifications. Each classification indicates the degree of health hazard presented by the recalled product.
- Class I: Recalls for products which may cause serious injury or death. For example, a label mix-up on a life saving drug falls in this class. The FDA will oversee the recall notification procedure to ensure it is adequate.
- Class II: Recalls for products which might cause serious injury or temporary illness. For example, most medical implants fall in this class. Another example is a drug that is under strength but is not used for life threatening situations. As with Class I recalls, the FDA oversees the notification process.
- Class III: Recalls for products which are unlikely to cause injury or illness but that violate FDA regulations. An example is a minor defect in product packaging. The FDA gives the manufacturer more leeway in the notification process.
What do I do if my drug is recalled?
If you have not received direct notice, but a drug you are taking is on the FDA’s website, you should contact your medical provider immediately.
Patients can search the FDA list of drug recalls for their medication and find out the date the recall started, the reason for the recall and the drug’s manufacturer. In some cases, a manufacturer may only recall a few lot or batch numbers of a medicine.