The Importance of Staying Informed on New OTC Product Releases, Recalls | APhA 2025
Dan Krinsky, BS, MS, RPh, FAPhA, and Stefanie Ferreri, PharmD, BCACP, FAPhA, discuss new OTC product releases, recalls, and other updates pharmacists should be aware of.
With the number of new OTC options to relieve minor illnesses and improve lifestyles, patients and pharmacists should be aware of the efficacy and safety of newly released OTC products and those that have been recalled.
“There was a number of products that were identified over the last 12 months that were recalled by the FDA,” Dan Krinsky, BS, MS, RPh, FAPhA, said in a session titled Rockin’ Remedies: Your Annual OTC Update presented at the American Pharmacists Association 2025 Annual Meeting and Exposition.1
It’s on pharmacy professionals to weed through the uncertainty of OTC product efficacy portrayed by FDA recalls. | image credit: bankrx / stock.adobe.com
According to Krinsky’s presentation, the FDA and various OTC product manufacturers have been busy in the past calendar year. The FDA approved new OTC products for sleep, congestion, cough, men’s health, and even syphilis testing, but they have also recalled a number of products for safety issues, microbial contamination, and other reasons.
READ MORE: Why Pharmacists Should Never Rely Solely on AI's OTC Recommendations | APhA 2025
“With the changes that are taking place at the federal government level to the organizations that affect a lot of the things that we do as health care professionals, I have no idea what this list is going to look like next year,” Krinsky said. “We have no idea what resources are going to be available to be able to perform these types of activities.”
Amid new OTC products constantly hitting the market and uncertainty at the federal level, Krinsky believes it’s up to pharmacists to stay informed on product updates and advocate for the safety and efficacy of these products—promoting the benefits of effective products and scrutinizing those that are not effective.
“We need to do a better job educating our [patients],” Stefanie Ferreri, PharmD, BCACP, FAPhA, said in the presentation.1 “I would encourage you all to go in there and advocate for removal of phenylephrine so that we can stop wasting our patients’ money.”
Among the myriad of new OTC products Krinsky and Ferreri warned against, phenylephrine stood out because of increased evidence that does not support its efficacy. In September 2023, the FDA concluded that oral phenylephrine was ineffective as a nasal decongestant but found no evidence highlighting safety concerns.2
Despite these conclusions, phenylephrine is still being used in combination with other ingredients in OTC decongestants and other products. However, according to Krinsky and Ferreri, phenylephrine is just the beginning of what pharmacists must know and look out for when managing patients’ OTC product regimens.
Krinsky pivoted to new products hitting the market and how pharmacists should stay informed about their cost-effectiveness and efficacy. He began with his thoughts on a Mucinex Sinus Saline Nasal Spray released in the past year, explaining how it’s marketed to clear congestion. However, Krinsky explained that the more expensive Mucinex product’s ingredients are just as effective as traditional saline nasal sprays.1
“There's a lot of products out there, especially in this whole area of supplements, where manufacturers are doing their best to try and get their product to market in a not-so-ethical way,” he continued. From brand names and labeling to marketed efficacy and safety, Krinsky does not believe patient outcomes and access are at the forefront when manufacturers are testing their OTC products.
He also mentioned a new Mucinex gummy marketed for children with misinformation in its product labeling as well as multiple Robitussin soft chew products that have recently hit the market without evidence supporting their mechanisms. He then touched on a new Alka-Seltzer product containing acetaminophen and dextromethorphan. Despite having 2 active ingredients potentially improving multiple patient outcomes, Krinsky still does not recommend it for children because of their potential adverse reactions to the active ingredients.
“We're at kind of a point where: Do we want to make recommendations for a product where we don't necessarily have the evidence to support either the benefits or the potential risks?” he said.1
OTC manufacturers have marketed a number of products that are not recommended and have not involved the perspectives of pharmacists and medication experts. With a slew of recalls and advocacy against certain products, however, it’s important for pharmacists to step in and utilize their expertise for the benefit of their patients. It’s on pharmacy professionals to weed through the uncertainty portrayed by FDA recalls and ineffective products coming to market.
“In my opinion, [it’s] kind of scary. If a lot of these products fall through the cracks, all we're doing is increasing risk to consumers,” Krinsky said. “[These] products [can] create some level of confusion for consumers and could also create a level of confusion for us as pharmacists and student pharmacists because a lot of these products are brand extensions. They're from manufacturers we're very familiar with, and yet, when I look at the potential role of these products on the market, I'm just not seeing it.”
