Drug Recalls in USA - Basics Everyone Should Know

Drug Recall in USA

A drug recall from US Market has a great significance in the pharmaceutical industry. It directly impacts the reputation and financial condition of the company. The higher the number of recalls, the lower the control of manufacturing and distribution activities. Drug recalls generally indicate the company's poor manufacturing methods and inability to produce a quality product.

Medicinal drugs are life-saving substances. They will bring new hope in the deceased persons and extends a patient's life span.

If a wrong or defective medicine enters the market, imagine how much harm is going to happen to the poor patients.

That is why regulators always sit on high attention to prevent the entry of defective products into the consumer market.

If the entry of a defective or inferior medicinal drug is observed into the market, by the FDA or manufacturer itself, that product will be recalled immediately from the market to avoid the risk to the patients.

What Is A Product Recall?

Product Recall

Generally, we observe that some of the medicinal drugs emerge as defective one or unsafe to consume, after distributing them into the market for the use of the public. This unusable or unsafe condition of drugs comes to the notice of the FDA in various ways. In some instances company itself identifies the problem and contacts the FDA. In some other cases, the FDA identifies the issues during their inspection at manufacturing facilities or patients notify the FDA on adverse reactions of medicines.

As soon as the information reaches the FDA, it guides the companies on product recalling. If you see the trend, the majority of drug recalls are voluntary. The manufacturer or distributor themselves recalled the products from the market. It is very rarely seen that FDA itself requests a company for a drug recall.

The FDA oversees the company's strategy of the recall and monitors the entire activity.

"Recall" applies to both prescription and over-the-counter drugs. The meaning of "Recall" is a company's immediate action for the removal or correction of the defective product. Here, 'removal' indicates removing a product to another location and 'correction' indicates repair or destruction without moving the product to another location.

What Are The Types Of Recall?

Types of Recall

The US FDA is classifying the recalls into three categories based on the severity of the defective drug adverse reactions or level of hazard. The agency established some guidelines to classify these recalls.

Class I : This category includes the defective products which pose a serious threat to the patient. The use of these drugs could cause serious health problems including death. These are highly dangerous drugs. This category of drugs can cause immediate danger.

Class II : This category includes the defective products which pose only a slight threat to the patient. The use of these drugs could cause a temporary health problem or slightly serious health issues. There is no immediate danger with this category of drugs, but the risk of danger is still present.

Class III : This category includes the products which unlikely to cause any adverse health reactions, but these drugs are manufactured by violating the laid regulations such as cGMP.

Click on the below link to view:
Drug Recalls 2018 Data Review

Why Do Companies Recall A Drug From Market?

Reasons for recall

There are so many reasons for the recall of medicinal drugs. Making of medicinal drugs is a very critical process. It requires a huge technical and intellectual support. Bringing safe drugs into the market for human use is a challenging task.

The limitations in the manufacturing process, deficiencies in the execution of the manufacturing process, violation of cGMP, inadequate analytical test methods, microbial contamination, use of low-quality packaging material, and improper packing of drugs are the main root causes for the presence of defective medicinal drugs in the market.

The use of these defective drugs could create serious health problems. Sometimes they can cause the death of human beings. For these reasons, the FDA is very keenly focusing on the drug market.

The US FDA has full authority to ask the firms for a drug recall if it identifies a reasonable probability for serious, adverse health consequences or death by the use of that particular drug.

A drug is recalled if:

  1. A lot of side effects are reported from the patients.
  2. Undeclared impurity is identified during analysis on FDA sampled material.
  3. Trace amounts of carcinogenic impurities are identified during analysis on FDA sampled material.
  4. Any labeling issues are identified.
  5. Any unapproved drug appears in the medicinal product.
  6. Any drug marketed without an approved NDA/ANDA.
  7. A trending health issue is identified by the Center for Disease Control and Prevention (CDC).
  8. FDA inspectors identify that the drug is manufactured violating cGMP regulations.
  9. Possible microbial contamination, which could lead to life-threatening infection, is identified.
  10. FDA identifies the risk of adulteration.
  11. Particulate matter such as colored particles, plastic particles and glass particles are observed in the drugs.

The above-said all undesired conditions are a threat to public health and can lead to fatal incidents. The defective drugs will kill the patients instead of saving them from the diseases. Hence, in such cases, it is an absolute requirement to recall all defective medicinal drugs from the market.

What Is The Process Of Recall?

Recall Process

In the United States of America (USA), there is a specific procedure to recall the drugs from the market and the FDA, a government agency which is responsible for the protection of public health, monitors the entire activity. The USA has an effective mechanism to work with drug recalls.

As soon as the FDA receives information, on the adverse reactions of FDA-regulated product, it identifies the defective product and starts to work with the manufacturer/distributor for the removal or correction of the product. It ensures the removal of products from medical stores and hospitals.

In some specific critical situations, where the level of hazard of a defective drug is very high, firms should conduct the recall in the way specified by the FDA. In majority cases, manufacturers themselves would conduct the recall voluntarily under the supervision of the FDA. A thorough evaluation will be done by the FDA on the process of recall, to assess the effectiveness of efforts that put on drug removal or correction.

It is the responsibility of the company to make the "drug recall" process successful. The company has to make its own follow-up checks to make the process smooth and complete. FDA takes a status report from the company on the progress of drug recall and also it verifies with a portion of customers to ensure whether they received the recall notification or not.

After the completion of "drug recall" from the market, FDA ensures the destruction or suitable reconditioning of the defective product. Sometimes the agency may witness the product's destruction. Subsequently, the agency investigates the defective product, to identify the root causes for its presence in the market.

The "drug recall" process completes only when the corrective actions taken by the company are reviewed by FDA and found satisfactory.

How The Product Recall Is Communicated To The Public?

Recall Communication

Once the adverse events or defective product's information reaches the FDA, it communicates with the public in various ways based on the seriousness of the situation. Normally, the firm will issue a public notification to inform the product recall. In that notification, the company explains the level of risk and the immediate steps to be taken to avoid the risk.

If the public notification of recall is not issued by the company, the FDA will issue it if the agency feels that that step is necessary to take to protect the public health.

The manufacturer and pharmacist will send the recall notification to the patients and explain them on the precautionary measures and steps to be taken as a consequence of drug recall.

Apart from this, the FDA also takes the help of the news media to spread the information of recall. But, all recalls are not announced in the news media. Only those, which have serious health hazards and need immediate attention of the public, will be announced in the news media.

FDA is publishing the details of all recalls every week on their website in the form of the FDA Enforcement Report. The agency is also communicating information to the public through its MedWatch program which is famously known as "The FDA Safety Information and Adverse Event Reporting Program".

Refer the following webpage for more details on Recalls in US market.

Recalls : Press releases announcing recalls

Recalls : Enforcement Report

Recalls : MedWatch


Drug recall refers to the method of removing or correction of a defective or unsafe drug from the market. These drugs are very harmful to patients and lead to severe health hazards.

FDA has full authority to ask companies to recall defective or unsafe medicinal drugs from the market.

Based on the severity and level of hazard, FDA is classifying the recalls into three types which are Class I, Class II and Class III. The drugs under Class-I are highly dangerous and leads to serious health hazards including death.

"Recall" requirements are applicable to both prescription and over-the-counter drugs. Most of the recalls are conducted voluntarily by the firms themselves. In rare cases, FDA asks the firms for a recall.

The FDA monitors the recall activity very closely and ensures the removal or correction of the product. Based on the level of the hazard, it communicates the recall information to the public in various ways.

FDA investigates the root causes for the presence of unsafe drugs in the market. If required, it initiates the legal actions against the firms.

The agency is communicating the public about the recalls through press releases, MedWatch program and news media.

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Author Profile


Ram Kumar Reddy

Ram Kumar Reddy is the founder of Pharma Times Now. Helping Pharmacy and Chemistry students, along with the pharma employees, in learning pharmaceutical science. He has 24 years of rich experience in the Pharmaceutical industry and well versed in quality systems. He worked with Dr.Reddys and Sai Life Sciences. He lives in Hyderabad, India.

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