FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | FDA Centennial

Email this Page To a Friend

The FDA and Product Recalls

By Michelle Meadows

• Types of Voluntary Recalls
• Evaluating the Health Hazard
• Notifying the Public
• Preventing Future Problems
• Evaluating Effectiveness
• When the Recall Is Not Voluntary

Most recalls of products regulated by the Food and Drug Administration are voluntary. One way or another, a company discovers a problem or a potential problem and then initiates a product recall in cooperation with the FDA. A recall is a way to remove or correct products that violate laws enforced by the agency.

Compared to court actions, which can be time-consuming and costly, a voluntary approach to recalls is preferable. "It's the most efficient and effective way to get defective products off the market quickly and protect the public health," says David Elder, director of the FDA's Office of Enforcement.

The FDA handles recalls for all the products it regulates--human drugs; devices and radiation-emitting products; biologics such as vaccines and blood products; veterinary products, which include animal drugs and animal feed; cosmetics; and about 80 percent of the foods consumed in the United States. The Food Safety and Inspection Service, part of the U.S. Department of Agriculture (USDA), handles recalls for meat, poultry, and certain egg products.

Types of Voluntary Recalls

Sometimes, a company discovers a problem with a product and then contacts the FDA. That's what happened in a highly unusual recall announced in February 2006 by Mead Johnson, based in Evansville, Ind., for a batch of its 24-ounce cans of GENTLEASE powdered infant formula.

Mead Johnson informed the FDA that metal particles were found in lot number: BMJ19, with a use by date of July 1, 2007. About 41,464 cans of this lot of recalled product were distributed beginning in December 2005 through retail stores nationwide. No illnesses had been reported at the time of the recall, but officials were concerned that the particles could damage the baby's respiratory system and throat, causing coughing, difficulty swallowing, or difficulty breathing.

In other instances, a company recalls the product after the FDA raises concerns. This action could occur after the agency inspects a manufacturing facility or evaluates reports of health problems. For example, the Cold Stone Creamery, in Arizona, removed all of its "cake batter" ice cream products from store shelves in July 2005 after the FDA told the company that several cases of Salmonella Typhimurium infection occurred among people who had eaten the cake batter products. This type of salmonella can cause abdominal pain, high fever, nausea, and vomiting in healthy people and can cause serious and sometimes fatal infections in small children, older people, and in those with weakened immune systems.

In rare cases, the FDA "requests" a recall. An example of this type of recall occurred in February 2006, when the FDA asked Cytosol Laboratories Inc. of Braintree, Mass., to recall all brands and sizes of its Balanced Salt Solution (BSS), which health professionals use to irrigate patients' eyes, ears, nose, or throat during cataract surgery and other procedures. The FDA requested the recall because product lots were found to have elevated levels of endotoxins, substances found in certain bacteria that can cause fever, shock, and changes in blood pressure and in other circulatory functions.

The FDA has received reports of a serious eye injury called Toxic Anterior Segment Syndrome (TASS), as well as complaints relating to injuries in more than 300 people who were given BSS. An estimated 1 million units of BSS products manufactured by Cytosol were distributed between December 2003 and December 2005.

In response to the FDA's request, Cytosol voluntarily recalled the following products: AMO Endosol, distributed by Advanced Medical Optics Inc., Santa Ana, Calif.; Cytosol Ophthalmics, distributed by Cytosol Ophthalmics, Lenoir, N.C.; and Akorn, distributed by Akorn Inc., Buffalo Grove, Ill.

Whatever the reason for a voluntary recall, the FDA's role is to oversee the company's recall strategy. In 2003, the agency released guidance for industry on managing all aspects of a recall. "The guidance assists the firm in recall strategy development, and encourages firms to provide the information FDA needs to evaluate and classify the recall," Elder says.

Evaluating the Health Hazard

For any product regulated by the FDA, a recall is handled by the appropriate FDA product center. A recall of a blood product, for example, would be addressed by the FDA's Center for Biologics Evaluation and Research. A recall of a drug for dogs would fall with the FDA's Center for Veterinary Medicine.

Once a recalled product is referred, the center convenes a board of experts who evaluate the health hazard associated with the recall. Scientists evaluate factors such as whether any diseases and injuries have already occurred; what risks apply to various segments of the population, including children, pets, and surgical patients; the degree of seriousness of the health hazard; and the volume of product involved and the distribution.

"Based on all of this information, the experts assign the recall a classification to indicate the relative degree of the health hazard, with Class I being the most serious," says Pete Cook, an FDA recall coordinator.

Here's a look at the classes of recalls:

Class I: A Class I recall involves a situation in which there is reasonable probability that the use of or exposure to the product will cause serious health problems or death. After a physician reported confusion over a dosing syringe, the Perrigo Co. of Allegan, Mich., initiated a voluntary recall in August 2005 of lots of liquid concentrated infants' oral drops that were packaged with a dosing syringe bearing only a 1.6-milliliter mark. The products included pain relievers containing acetaminophen and cough and cold drops. The drops were recalled because the dosing syringe could be confusing in determining the proper dose for infants younger than 2 years and could lead to overdosing, which could be fatal.

Class II: A Class II recall means that the use of or exposure to the product may cause temporary or medically reversible health problems or that the probability of serious health problems is remote. McNeil Consumer & Specialty Pharmaceuticals of Fort Washington, Pa., was involved in a Class II action when it recalled 4-ounce bottles of Children's Motrin Dye-Free Berry Flavor Liquid in September 2005. Some of the products intended for destruction because of "black specks" and "foreign organic material" were possibly sent to retail stores.

Class III: A Class III recall is the least serious and indicates that exposure to the product is not likely to cause health problems. The American Bottling Co. of Ottumwa, Iowa, had a Class III recall in August 2005, when it recalled certain cases of A & W Sparkling Vanilla Cream Soda that were labeled as caffeine-free. The bottles of soda actually contained caffeine.

In 2005, more than 5,300 products regulated by the FDA were recalled. Of these products, 466 were Class I, 3,781 were Class II, and 1,091 were Class III. Most Class I recalls in 2005 were in the food category.

Notifying the Public

An evaluation of the health hazard helps companies determine the strategy for communicating risks associated with a recalled product. As part of reviewing a company's proposed recall strategy, the FDA looks at the depth of the recall, the extent of public warnings needed, and whether the recall is being extended to the wholesale, hospital, pharmacy, retail, patient, or consumer levels.

"If companies sell directly to consumers and can identify them easily, a letter could work," Elder says. "But if we're talking about a can of soup--a situation where only consumers know whether they bought a product or not--then the approach has to be much broader so that we can reach as many people as possible."

Class I recalls almost always warrant a release to the media, Elder says. "When a recalled product has been widely distributed, the media is a very effective way to reach large numbers of consumers," Elder says.

Many other recalls aren't announced in the media, but they go into the FDA's weekly Enforcement Report, posted at www.fda.gov/opacom/Enforce.html on the agency's Web site. This document lists each recall according to classification, with the specific action taken by the recalling firm.

Companies must report to the FDA whether the recall will be posted on the company's Web site, what customers are being instructed to do, and how products should be returned, if applicable. Key information should be communicated clearly to consumers, including the name of the product being recalled, the lot numbers, serial numbers, or other identifying information, and the reason for the recall.

"Consumers need to take any recall communication seriously and determine whether they are impacted," Elder says. "In some cases, it may be that only a small portion of the product is actually affected. But to be on the safe side and to operate within current good manufacturing practice regulations, the entire product line, lot, or model may be recalled."

An example of a case in which consumers were instructed to return the recalled product was when RC2 Brands of Stoughton, Mass., recalled certain teething rings in January 2006. The liquid contained in the rings is contaminated with bacteria that may cause serious illness if swallowed by babies, if it enters the lungs, or if it is absorbed through a cut in the mouth. The risk of illness is especially high in infants whose immune systems are compromised by malnutrition, by blood problems, or from cancer therapy.

The teething rings were sold nationwide between July 2005 and January 2006 at major retail, grocery, and specialty stores. About 352,000 were distributed in the United States. Products included six types of teethers, including the Disney Soft Cool Ring Teether--Styles #Y1470 and #Y1490 and Sesame Beginnings Chill & Chew Teether--Style #Y3095. As of February 2006, the firm had received 105 complaints of fluid leakage, 14 reports of sharp edges that resulted in nine incidents of cuts, and two reports of babies biting through rings.

"For this recall, the firm asked consumers to place the teethers in a plastic bag and return it to the company, but consumers should be aware that some recalls don't involve returning products," says Jay Rachlin, associate director of the Division of Device User Programs and Systems Analysis in the Center for Devices and Radiological Health (CDRH). Sometimes, the recall doesn't involve a removal, but rather a correction. This solution is a way to address a problem with the product where it's sold. For example, a medical device in a hospital might need a new label or some kind of reprogramming.

A recall also may be issued when a company has released new warnings and instructions for a device. In June 2005, Vail Products Inc. of Toledo, Ohio, recalled about 5,000 enclosed or canopied bed systems because patients could become entrapped or suffocate. An alternative to physical or drug restraint, padded beds are used to enclose patients with cognitive impairment, unpredictable behavior, spasms, seizures, or other disorders.

At the time of the recall, the FDA was aware of 30 entrapments, of which eight resulted in death. The company did not retrieve or replace the beds; they couldn't be returned to the company. But the company provided new instruction manuals and warning labels, and stopped manufacturing, selling, and distributing the bed systems.

"With an implanted device," Rachlin says, "a recall may mean that doctors and patients should discuss the risks of removing the device compared to the risk of leaving it in place." That is what happened when Guidant Corp. of St. Paul, Minn., announced a voluntary Class I recall in July 2005 of certain pacemakers that were manufactured between Nov. 25, 1997, and Oct. 26, 2000.

A seal within the devices can leak, allowing moisture to affect the electronic circuits. This defect can prevent the pacemaker from providing pacing or can cause a rapid heart rate. The problems could occur without warning and lead to loss of consciousness, heart failure, or death. As of July 2005, Guidant had received reports that 69 pacemakers may have failed because of the leakage.

In a letter to physicians, Guidant gave physicians recommendations about how to identify a leak-related malfunction and other advice for minimizing the risk of pacemaker failure.

Preventing Future Problems

Companies should work with the FDA to identify the root causes for a recall and to prevent the problem from recurring. "The FDA's role is to oversee the recall and verify that the firm's steps reflect the right conclusions about the problem and how it should be corrected," says Mel Szymanski, senior recall coordinator for the FDA.

In December 2005, Diamond Pet Food, Meta, Mo., traced the cause of injuries and deaths of dozens of dogs to a potent toxin called aflatoxin, which was found in some of the pet food manufactured at the company's facility in Gaston, S.C. The aflatoxin came from a fungus found on corn that was used to make the food. Experts say that severe drought followed by high moisture contributes to the growth of this fungus.

Animals that consume aflatoxin may experience severe liver damage. Signs of illness in pets include sluggishness, lethargy and reluctance to eat, a yellowish tint to the eyes and gums, and severe or bloody diarrhea.

"From the first week of the recall, we have been working with FDA to get the word out to potentially affected households and improve our food safety procedures and protocols," says Mark Brinkman, chief operations officer of Diamond Pet Food.

Testing showed that the products affected with the toxin were Diamond Professional for Adult Dogs, best by date of Jan. 29, 2007; Diamond Maintenance Dog Food, best by dates of April 3 and 5, 2007; and Diamond Premium Adult Dog Food, best by date of April 11, 2007.

The company recalled product date codes several weeks before and after the suspected dates out of precaution. "Far below one percent of what we recalled contained toxic levels," according to Brinkman, who says his company acknowledges the tragic situation for its customers. "We had a breakdown in quality control that cost the lives of customers' pets, and we are working to make things right for the families as best that we can."

Diamond Pet Food has taken several actions to prevent oversights from happening again. "First, we've implemented sampling and testing protocols for corn that require two signatures throughout the chain of custody--that of the employee and the immediate supervisor," Brinkman says. "The USDA requires four probes per load of corn. Diamond is conducting 12 probes per load."

He says that Diamond also has added aflatoxin testing to the finished product and is working with the USDA to source corn from areas that are less likely to have aflatoxin-tainted supplies.

Evaluating Effectiveness

Companies carry out the recall, and the FDA acts as a monitor, Szymanski says. The FDA encourages companies to make sure that recall notification letters reached the target audience, that the letter was read, and that instructions were understood.

Classification of the recall helps the FDA determine the number of audits needed to check on a recall. An audit check, whether done by personal visit, phone call, letter, or a combination, is made so that the FDA can verify who has been notified about the recall. Check levels range from A to E. A "Level A" check means that 100 percent of those targeted were contacted about the recall. A "Level E" check means that no effectiveness checks were needed.

The FDA requests that recalling firms submit periodic status reports indicating how many people are responding to the recall. "The recall is considered complete after all of the company's corrective actions are reviewed and deemed appropriate," Szymanski says. "The FDA evaluates whether all reasonable efforts have been made to remove or correct the product, and whether all outstanding product is recovered or destroyed."

When the Recall Is Not Voluntary

Though most recalls are voluntary, there are times when the FDA mandates a recall. The FDA can "order" a recall in some cases involving infant formulas, biological products, and devices that present a serious hazard to health. In 2002, the FDA ordered CyroLife Inc., Kennesaw, Ga., to recall and prevent further use of human tissue that was processed from October 2001 to August 2002.

During an inspection in 2002, the FDA found significant violations of FDA regulations and issued a Warning Letter. The FDA issued the recall order after determining that CryoLife had failed to take adequate measures to address possible infectious disease contamination of tissue. Tissue from a donor processed by CryoLife was associated with the Nov. 7, 2001, death of a patient who received a soft tissue implant during reconstructive knee surgery.

If FDA experts determine that a recall wouldn't be effective or if a recall proves ineffective, or if the violation is continuing, then the agency can take legal action such as injunctions and seizures. An injunction is a civil action taken to stop production or distribution of a product that violates the law. A seizure involves removing a product from the market by requesting a court to direct a U.S. Marshal to take possession of the goods.

The FDA conducted a seizure in May 2002 of New Choice Food mini-gel candies at the company's facility in Irwindale, Calif. In 2001, the FDA had issued warnings against consuming mini-cup gel candies that contain the ingredient "konjac," also known as conjac, konnyaku, yam flour, or glucomannan. The FDA and the Consumer Product Safety Commission considered this product a choking hazard, especially to children and older people. The candy, which was sold under various brand names and distributed by different companies, doesn't readily dissolve in the mouth.

At the time of the seizure, six deaths had been reported from choking in the United States, and deaths were also reported in other countries. The FDA issued an import alert in 2001 to keep the candy out of the country. Other firms voluntarily recalled the gel candies, but New Choice Food did not.

"When companies are unwilling to comply with the law, we take decisive action to protect consumers," Elder says. "This sends a strong signal that the agency doesn't tolerate harmful products in the marketplace."

FDA-Regulated Products Recalled in 2005

In 2005, there were recalls for 5,338 products regulated by the FDA. Each recall is assigned a classification to indicate the degree of the health hazard. Class I recalls are the most serious.

Sign Up for Recall Alerts

News releases about recalls of products regulated by the FDA can be delivered directly to an e-mail account. Go to the FDA's free e-mail lists page at www.fda.gov/emaillist.html and click on "FDA Recalls."

For More Information

The FDA's page on recalls
www.fda.gov/opacom/7alerts.html

Listing of recalls by six federal agencies
www.recalls.gov

The FDA's Enforcement Report
www.fda.gov/opacom/Enforce.html

The FDA's MedWatch
www.fda.gov/medwatch/index.html

FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | Privacy | Accessibility

FDA Office of Public Affairs
FDA Consumer magazine