When you’re stuck with a nasty cold or the flu, the last thing you want to worry about is whether your medicine is safe to take. Yet recently, more than 4,000 bottles of a prescription cold medication were quietly pulled from pharmacy shelves across Ohio. The recall, which started a full year ago and was only recently closed, highlights issues that many people never think about when picking up their prescriptions. The affected medication contained higher-than-approved levels of its active ingredients, including an opioid, which could have led to serious side effects for unsuspecting patients. Understanding what happened and why it matters can help you stay informed about the medications you and your family rely on during cold and flu season.
The recall affected prescription cough syrup with codeine
The medication at the center of this recall was Guaifenesin and Codeine Phosphate Oral Solution, a prescription cough syrup that combines an expectorant with an opioid pain reliever. This particular formulation came in 16-ounce bottles manufactured by PAI Holdings, LLC, operating as Pharmaceutical Associates Inc. in South Carolina. The bottles contained a 100 mg/10 mg per 5 mL dose and were identified by National Drug Code 0121-0775-16, with lot number 4B07 and an expiration date of October 31, 2026. If you received a prescription for this specific medication in Ohio during 2025, it’s worth checking your medicine cabinet to see if you still have any of these bottles.
According to the updated FDA report from January 7, 2026, the recall involved exactly 4,080 bottles distributed primarily through Ohio pharmacies. The company voluntarily initiated the recall after discovering the problem, which is better than waiting for regulators to force action. What makes this recall particularly noteworthy is the year-long timeline from start to finish. Many people assume recalls happen quickly and get resolved within weeks, but this case shows that the process of tracking down affected products, notifying patients, and ensuring all bottles are removed from circulation can take considerable time and coordination between manufacturers, pharmacies, and health authorities.
Superpotency means the medicine was too strong
The term superpotent might sound like something positive at first, but when it comes to medications, it’s actually a serious problem. Superpotency means the drug contained higher concentrations of its active ingredients than what was approved and stated on the label. When you take medication, your doctor prescribes a specific dose based on your weight, age, and condition. If the medicine is stronger than labeled, you could unknowingly be taking too much without realizing it. This becomes especially concerning with this particular recall because one of the active ingredients is codeine, an opioid that carries significant risks even at normal doses.
The Cleveland Clinic advises patients to take cough suppressants containing codeine exactly as prescribed and for the shortest time possible. Higher doses or prolonged use can increase the risk of serious complications, including respiratory depression, where breathing becomes dangerously slow or shallow. Other potential side effects from taking too much codeine include severe drowsiness, confusion, constipation, and in extreme cases, overdose. For children, elderly patients, or anyone taking other medications that interact with opioids, the risks multiply. The superpotency issue in this recall meant that patients following their doctor’s instructions might have inadvertently been taking significantly more medication than intended, putting them at elevated risk.
Sodium benzoate preservative may have contributed to the problem
The FDA report suggested that the superpotency issue might have been connected to sodium benzoate preservative, a common ingredient added to medications, foods, and cosmetics to prevent mold and bacterial growth. You’ve probably consumed sodium benzoate many times without knowing it, as it’s found in soft drinks, salad dressings, and pickled foods. In small amounts, this manufactured compound is generally considered safe and effective at extending shelf life. However, the amount and conditions under which it’s used matter significantly. When sodium benzoate is present in higher concentrations or combined with certain other ingredients, questions about its effects begin to emerge.
According to the Environmental Working Group, sodium benzoate has been linked to various concerns when used in larger doses, though these findings remain debated in scientific circles. The EWG notes particular concerns when sodium benzoate combines with ascorbic acid, citric acid, or vitamin C, especially in larger amounts. Under certain conditions like elevated temperatures or excessive sunlight exposure, sodium benzoate can form benzene, a chemical associated with blood cancers. While this recall was classified as Class III, the lowest risk level for recalls, understanding how preservatives can affect medication potency and stability helps explain why pharmaceutical manufacturing requires such strict quality controls and why these recalls matter even when serious harm hasn’t been widely reported.
Class III recalls are the lowest risk category
Not all recalls carry the same level of urgency or danger, which is why the FDA classifies them into three categories. Class I recalls are the most serious, involving products that could cause severe health problems or death. Class II recalls involve products that might cause temporary or medically reversible health problems, with a remote possibility of serious harm. Class III recalls, like this cold medicine case, are the least urgent and apply to products that aren’t likely to cause adverse health consequences but still violate FDA regulations in some way. The classification helps health officials and consumers understand how concerned they should be and how quickly they need to act.
Even though this recall received a Class III designation, that doesn’t mean you should ignore it if you have the affected product. The classification reflects the overall risk to the general population, not necessarily the risk to every individual who took the medication. Someone who took multiple doses of the superpotent medication, especially a child or someone with other health conditions, could still have experienced significant side effects. The Class III rating simply means that widespread serious harm was unlikely based on the specific circumstances of this recall. If you took this medication and experienced unusual drowsiness, breathing difficulties, or other concerning symptoms, it’s worth mentioning to your doctor even if the recall is categorized as lower risk.
Cold and flu season makes medicine recalls more concerning
The timing of medicine recalls during cold and flu season adds an extra layer of concern for families trying to stay healthy. National health experts reported on January 5 that Americans seeking medical help for acute respiratory illnesses reached very high levels for the first time in the current season. When more people are sick, more prescriptions get filled, and the potential number of people affected by a recall increases. Parents dealing with sick children, elderly individuals managing multiple health conditions, and anyone with a compromised immune system rely heavily on these medications to manage their symptoms and prevent complications from respiratory illnesses.
What makes this situation more frustrating is that many people don’t hear about recalls until long after they’ve finished taking the medication. The recall affecting Ohio pharmacies started in January 2025 but wasn’t fully concluded until January 2026. During that year, countless patients may have taken the medication without knowing about the superpotency issue. This highlights the importance of staying connected with your pharmacy and checking FDA recall announcements, especially during peak illness seasons. Most pharmacies will attempt to contact patients who received recalled medications, but if you’ve moved, changed phone numbers, or the pharmacy has outdated contact information, you might never receive notification. Checking your medicine cabinet periodically and comparing lot numbers against recall lists can help catch problems before they affect your family.
Other recent cold medicine recalls show this isn’t isolated
This prescription cough syrup recall isn’t the only medication issue consumers have faced recently. In a separate and much more alarming case, Gold Star Distribution in Minneapolis issued an urgent recall of numerous cold and flu products after FDA inspectors discovered rodent feces, bird droppings, and other contamination in their facility. That recall affected over-the-counter medications including DayQuil, NyQuil, Tylenol, Advil, and many other familiar brands that millions of Americans keep in their medicine cabinets. The contamination created risks of exposure to harmful bacteria like salmonella, which can cause fever, diarrhea, nausea, and vomiting, with particularly serious consequences for infants, elderly individuals, pregnant women, and those with weakened immune systems.
The Gold Star recall applied only to products held at their Minneapolis facility and didn’t affect items shipped directly from manufacturers to retail stores. This distinction matters because it shows how distribution practices can create isolated pockets of contaminated products. The FDA investigation found that Gold Star’s facility operated under conditions that failed basic health and safety standards, with contaminated surfaces and airborne particles from animal waste creating unacceptable risks. While no illnesses were reported in connection with either recall, these cases demonstrate that both prescription and over-the-counter medications can face quality control issues that put consumers at risk, making it essential to stay informed about recalls affecting products you use regularly.
How to check if your medicine is recalled
Finding out whether your medications are affected by a recall doesn’t have to be complicated, but it does require you to know where to look. The FDA maintains a searchable database of all drug recalls on their website, which you can access anytime. When checking a medication, you’ll need specific information from the bottle: the National Drug Code, which is a series of numbers usually found on the label, the lot number, and the expiration date. These details help you determine whether your specific bottle is part of a recall, since recalls often affect only certain batches rather than all products from a manufacturer.
Your pharmacy can also be a valuable resource for recall information. Most major pharmacy chains have systems in place to track recalled medications and contact affected patients. When you fill a prescription, the pharmacy records the NDC, lot number, and your contact information, allowing them to reach out if a recall is announced. However, this system only works if your contact information is current, so make sure to update your pharmacy whenever you change your phone number or address. You can also sign up for FDA recall alerts through their website, which will send you notifications about new recalls. Taking a few minutes each month to check the FDA recall page for medications your family uses regularly can provide peace of mind and help you catch potential problems early.
What to do if you have recalled medication
If you discover that you have a recalled medication in your home, don’t panic, but do take action promptly. First, stop using the medication immediately, even if you haven’t experienced any problems. Contact your doctor or pharmacist to discuss alternative treatments, especially if you’re currently sick and relying on the medication to manage symptoms. Your doctor can prescribe a different medication or recommend an over-the-counter alternative that’s safe and effective. If you’ve already taken some or all of the recalled medication, mention this to your healthcare provider so they can monitor you for any potential side effects or complications related to the recall issue.
For disposing of the recalled medication, don’t just throw it in the trash or flush it down the toilet, as this can create environmental problems and doesn’t provide proof of disposal if a refund is offered. Many recalls, like the Gold Star Distribution case, require you to destroy the product and provide proof to receive a refund. Take photos of the product label showing the NDC, lot number, and expiration date before disposal. Most communities have medication take-back programs at pharmacies or police stations where you can safely dispose of unwanted medications. Bring your receipt if you have it, as some recalls offer refunds or replacements. If you experienced any adverse reactions while taking the recalled medication, report them to the FDA’s MedWatch program, which tracks safety issues and helps regulators identify patterns that might indicate more serious problems requiring additional action.
Prevention starts with asking questions at the pharmacy
While you can’t prevent manufacturers from making mistakes, you can take steps to protect yourself and your family when picking up medications. When your pharmacist hands you a prescription, take a moment to verify the medication name, strength, and dosage instructions match what your doctor prescribed. Ask questions if anything looks different from what you expected, including changes in the pill’s appearance, bottle size, or manufacturer. Pharmacists are required to counsel patients on new prescriptions, so take advantage of this opportunity to understand what you’re taking, how it should work, and what side effects to watch for.
Make sure your pharmacy has your current contact information so they can reach you if a recall is announced. Ask them about their recall notification process and whether they offer text or email alerts in addition to phone calls. Keep all medication in its original container with the label intact, as this makes it easier to identify the product if a recall occurs. Store medications in a cool, dry place away from direct sunlight, since improper storage can affect potency and stability. Consider keeping a simple list of all medications your family takes, including the NDC and lot numbers, which you can quickly reference if you hear about a recall. These small steps won’t eliminate all risks, but they significantly improve your ability to respond quickly and effectively when problems arise, keeping your family safer during cold and flu season and throughout the year.
Medicine recalls like this one serve as important reminders that even everyday medications require careful oversight and attention. While the vast majority of prescriptions are perfectly safe, quality control issues can happen at any point from manufacturing to distribution. Staying informed about recalls, knowing how to check your medications, and maintaining open communication with your healthcare providers are your best defenses against potential problems. The next time you reach for that cough syrup or cold medicine, take a moment to check the label and make sure it hasn’t been recalled.
