Typically, a recall is a product that is removed from the market or a correction made to the product because it is potentially harmful, mislabeled or adulterated in some manner that is inconsistent with the original formula as it pertains to interstate commerce.
Medicine may be recalled for several reasons: because the product poses a hazard to the general public compromising their health and safety, may potentially be contaminated, mislabeled or poorly manufactured. Recalls are classified in three classes (I, II, III) depending on the severity of consequences affecting consumers.
It is the responsibility of manufacturers to ensure that their products are safe to the general public. When this is in question, there are three options available:
- Voluntary recall by the manufacturer
- The FDA may request that the product be removed from the shelf
- The FDA may recall the product as mandated by its recall authority.
Due to the sensitive nature of recalled medicine and the side effects it can cause people, it is of the utmost importance that patients and consumers have at their disposal the medicine as it was originally intended. In some cases, the recalled product may be replaced with another medicine.
Concerned consumers may find out that a particular medical product has been recalled by:
- News media. For widespread distribution of cosmetic products, the news media may announce it in the media (newspaper, television news report).
- Consumers may also track cosmetics recalls on: http://www.recalls.gov/medicine.html
- Social Media. Consumers may interact directly with the FDA on Twitter (@FDArecalls) for questions or queries on a particular product.
- Consumers may also sign up for free email updates as well as the Recall Subscription List on the FDA site: http://www.recalls.gov/medicine.html
Once you have discovered that a medicine has been recalled, you have several options:
- Check with your doctor or health professional for the best course of action.
- Consumers may also return the recalled product to the store that was purchased as part of the return and refund policy.
- Safely discard the recalled medicine.
If you haven’t done so, register to receive safety alerts on FDA’s Recall Notification Email system: http://www.fda.gov/Drugs/DrugSafety/DrugRecalls/default.htm. Additionally, if you have a safety problem or complaint, you may also file a complaint on the FDA gateway (MEDWATCH): http://www.fda.gov/Safety/MedWatch/default.htm.
The Food and Drug Administration (FDA) has jurisdiction on recalls involving medications. As such it ensures that manufacturers adhere to certain safety and labels to protect consumers.
Past Medicine Recalls