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How to Understand FDA Lot Numbers

By Contributing Writer ; Updated July 27, 2017

Occasionally you will read or hear an announcement that certain lot numbers of a product have been recalled by the Food and Drug Administration (FDA). These numbers may seem like scientific jargon designed to keep consumers in the dark about the processes of food and drug manufacturing, which may, in turn, spawn confusion and fear for consumers who have recently heard about a product recall. This confusion and fear, however, is unwarranted. In fact, lot numbers should be a source of comfort to consumers.

Know Your Numbers

  1. Understand the source of lot numbers. Lot numbers are not issued by the FDA. Rather, they are issued by the manufacturer of the product. When manufacturers produce a product, they do so in batches. Each batch is assigned a unique number that makes it possible for manufacturers to track exactly when a problem occurred and which products need to be recalled. (Think of it as the product's Social Security number.)

  2. For example, without lot numbers, a problem with one bottle of Tylenol would result in every bottle of Tylenol being removed from the shelf, thereby making the drug unavailable to consumers. With lot numbers, manufacturers are able to remove the specific bottles affected while still maintaining product availability.

  3. Understand FDA recall procedures. The FDA requires food and drug manufacturers to report products that pose a risk to the public, these risks being broken down into Class 1, Class 2, and Class 3. Class 1 is when the product is likely to cause serious health problems, Class 2 is when the product may cause reversible or treatable health problems, and Class 3 is when the product is not likely to cause any health problems. Both Classes 1 and 2 demand presses releases.

  4. Find your lot number. If you hear about a product recall and you have the product in your house, find the lot number, located on the packaging. The lot number may or may not be labeled as such; in other words, you may see “lot” followed by the number, but not always.

  5. When looking for the lot number, keep in mind that it will not be printed as a standard part of the product label since the product label doesn’t change, whereas the lot number changes with every batch. Instead, look for a number that is stamped onto the packaging.

  6. Report concerns yourself. Although the burden of reporting bad products falls on the manufacturer, there are means in place for consumers to report harmful foods and drugs. The FDA provides consumer complaint coordinators for all regions of the United States.

  7. These coordinators evaluate complaints and can determine whether the issue should be escalated and investigated, which can lead the FDA to force a recall that wasn’t otherwise prompted by the manufacturer.

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