Allay Consulting November Newsletter: Product Recalls & What to Expect

Product Recalls & What to Expect

Have you ever found a foreign object in your food, or woke up not feeling too good from the previous days food? Each year in the United States, 1 in 6 people get sick from foodborne disease, 128,000 are hospitalized, and 3,000 on average die. In the United States, we have seen large recalls involving listeria in cantaloupes, salmonella in peanut butter, metal pieces in ground beef, and more recently cannabis recalls due to potentially unhealthy levels of molds, yeasts, pesticides and heavy metals.

Unfortunately, all companies experience at least one or multiple recalls during their lifetime. In efforts to protect consumers, the FDA and local/state regulatory authorities publish product recalls to notify consumers of confirmed and potential contaminated products. The recall could stem from your own product or an outside manufacturer; think of in-house manufactured ingredients, out-of-house added ingredients or primary packaging. What to expect from a recall may differ from state to state, but the overall process is similar with the FDA’s. We hope to clarify what to expect during a recall and how this can prepare you for dealing with this type of situation.

The very early steps of a recall start with determining the need for a recall. You may conduct a voluntary recall on your own or you may receive a notification that your product is at fault which could also lead to a recall. This could include a simple consumer complaint, consumer social media post, hospital visit, or worse…death. No matter the origin, your product could be the linking connection to the complaints. Let us say a regulatory authority notifies you that your product is the common source of illness. What is next?

You must quickly identify which products are associated with the complaints. Maybe a common ingredient, common manufacturing date, equipment, staff, packaging material, etc. You will need to be able to identify which products are included in the recall. Let us hope your traceability is on point! Having a strong product traceability program will expedite identifying which products need to be recalled and which consumers need to be notified. If traceability is not in place, the recall could expand past the identified product to include “any and all” products.

Once the product(s) is identified, you must contact and notify any consumers, wholesalers, and distributors to whom the product was sold to. This could include contact via phone call, mass email correspondence, social media posts, press releases, and the most profound is the FDA publishing the recall on a national level. Expect product returns, reimbursements, and disposals for the recalled product.

After publishing the recall and receiving returned product back, what’s next? An investigation must be conducted on the recalled product to determine the root cause for the incidents. This root cause will help determine how to best move forward. Once investigated, a Corrective Action must take place. You may choose to rework the product or you may choose to dispose of the product. Either decision must be based on science and have a clear path of documentation. Adhering to a Corrective Action Preventive Action (CAPA) Plan is key to correcting the impacted product and ensuring it doesn’t happen again.

You’re not done just yet; the next step is preventing this from occurring again. Understanding the root cause of the non-conforming product will reveal options for preventing a similar disruption in the future. Perhaps an ingredient was purchased from an unapproved supplier, failed product testing, was not tested, equipment malfunction, sanitizer chemical was too concentrated, the list goes on and on.

A recall is never ideal, but you can control how smoothly a recall flow. Remember to work with your local or state government regulatory agencies when conducting a recall. Additionally, you can prepare for potential recalls by promoting Good Manufacturing Practices (GMP) throughout the facility, utilizing an Approved Supplier Program, applying a CAPA plan, Consumer Complaint & Non-Conforming operating procedures, and have a complete Recall Plan in place. Reach out to Allay Consulting for assistance on various GMP plans which include the plans described above.

Reminder – Colorado Marijuana Companies, beginning 1/1/2021 you must have a Sampling Method SOP, CAPA Plan and Recall Plan in place. Reach out and Allay Consulting can take this time-consuming task off your plate. Do not get caught unprepared for a regulatory audit!


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