In 2021 alone, FDA-regulated companies reported 427 recalls at the end of the year. On average, 1,279 drugs are recalled annually. Despite the abundance of recalls, it is not always a cut-and-dry process. Contrary to popular belief, the FDA cannot execute a drug recall, but it can order the recall of a device. Instead, the decision to issue a recall rests with manufacturers. Depending on the potential hazards and reported injuries or deaths, the FDA will categorize a recall in varying classes. The decision and process of pulling devices or drugs from the market can prove complicated and challenging.
What is a Recall?
A recall is a process of removing or correcting products that violate laws administered by the Food and Drug Administration (FDA). Recalls are voluntary actions that serve as an alternative to FDA-initiated court action for removing or correcting violative products. An entity usually initiates a recall to protect the public from a defective or harmful product. Manufacturers and distributors will issue a voluntary recall to preserve the well-being of consumers in the event a product presents a supposed risk. Various problems may prompt a recall, including faulty packaging, bacterial infections, or malfunctioning implanted devices. Medical devices, drugs, vaccines, pet treats, food and beverages, and cosmetics are all subject to potential recalls.
Initiating a Recall
According to the FDA, manufacturers and distributors have a responsibility to keep the public safe from harmful products or devices. While the agency can recommend a drug recall, the FDA cannot mandate a company to recall potentially hazardous drugs. In these cases, the manufacturer or distributor must decide to issue a recall. However, the FDA can force a manufacturer to recall a device if it presents a reasonable probability of injury or death for consumers. In addition to devices, the FDA can also demand mandatory recalls of vaccines and blood products made from human cells or tissue. The FDA typically reserves these orders for urgent situations.
Oftentimes, companies do not initiate recalls unless the FDA raises concerns over the product. The FDA may identify issues through adverse health reports, scientific studies, or by inspecting manufacturing facilities. Although, companies may choose to remove or correct a product for any reason and under any circumstance. In firm-initiated recalls, the company must immediately inform the FDA.
Health Hazard Evaluation
The FDA examines the possible health hazards associated with products in the process of recall or ones considered for recall. During this review, the agency assesses a comprehensive list of criteria against the drug or device. The FDA takes the following factors into account:
- Whether it has received reports of injury or death caused by the product
- Whether any existing conditions could contribute to a clinical situation that could expose humans or animals to a health hazard
- Determining what segments of the population are at greater risk
- Analyzing the severity of the potential hazard
- The likelihood of a hazard occurring
- Assessing the long-term consequences if the hazard were to happen
This determination allows the FDA to consider how to categorize the recall.
The FDA designed a numerical designation dependent on the health hazard evaluation for recalled products. The agency divides the classes into:
- Class I – the product presents a reasonable probability of adverse health consequences or death for users. This is the FDA’s most severe type of recall.
- Class II – the product may cause temporary or medically reversible adverse health consequences. Also, the possibility of serious injury is not as likely as in Class I recalls. Class II is the most common recall.
- Class III – the product is not likely to cause any harm.
After the FDA determines the classification for the recall, the agency advises the recalling company to formulate a recall strategy. The FDA instructs the firm to consider the health hazard evaluation, how easy it is to identify the product, and how apparent the deficiency is for the consumer when developing a recall strategy. Next, the FDA will review the recall strategy and work with the company to make any necessary recommendations. An effective recall strategy will tackle three key elements, depth of recall, public warning, and effectiveness checks.
Depth of recall dictates what level the recall applies to in the distribution chain. The product’s potential hazard decides if the recall extends to a consumer level, retail level, or wholesale level. Also, a recall strategy may or may not include a public warning, which alerts the public that a recalled product may cause injury. If a recall necessitates a public warning then the recall strategy will define if general or specialized news media will deliver the information. Finally, the manufacturer will perform effectiveness checks to ensure that all appropriate parties indicated by the depth of recall received notification and took the appropriate action. The recaller may utilize personal visits, phone calls, letters, or a combination of these to conduct effectiveness checks.
After the Initial Recall
The FDA requires the manufacturer to submit periodic recall status reports so the agency can monitor the recall’s progress. How often the company sends these reports depends on the urgency of the recall, but generally, the FDA sets the reporting interval between two to four weeks. Eventually, once the company meets the requirements defined in the recall strategy to correct or remove the affected product, the FDA will terminate the recall.
Each year the FDA warns the public of numerous recalls ranging from medical devices to contaminated food products and dangerous drugs. FDA approval of devices, drugs, and products, does not assure safety. Even if a product obtains FDA authorization, it does not prevent it from being recalled in the future.