What was recalled
The U.S. Food and Drug Administration (FDA) has issued a recall for a specific topical pain relief product manufactured by Lexia LLC and distributed under the brand name Broadway Joe's. The item in question is the Broadway Joe's Pain Cream, which is packaged in small, 2-ounce jars. This particular formulation is notable for its combination of ingredients, including Histamine Dihydrochloride at a concentration of 0.025%, 1500mg of CBD Isolate, and 1000mg of Hempseed oil. While these components are often marketed for their soothing and anti-inflammatory properties, the recall is not related to the efficacy or safety of these active ingredients themselves. Instead, it stems from manufacturing process failures that compromised the integrity of the product during production.
The products affected by this recall were produced for Broadway Joe's, a company based in Franklin, Tennessee, with the address listed as 37067. The specific items bearing National Drug Code (NDC) number 83088-8120-5 and Universal Product Code (UPC) 8 50041 64003 7 are the only ones included in this action. It is crucial to identify the exact lot numbers to determine if your jar is part of this batch, as the recall does not apply to all Broadway Joe's Pain Cream ever made, nor does it necessarily cover every production run by Lexia LLC. The affected lots are T1110, T1111, T1112, T1113, and T1114. Each of these lots carries a specific expiration date ranging from January 7, 2027, to January 17, 2027, which can help you verify the age and origin of your product.
In terms of availability, this recall is limited geographically. The affected products were distributed exclusively within the state of Colorado. If you purchased this cream in any other state, it was not part of this specific distribution chain and is therefore not subject to this particular safety alert. The recall was officially announced on August 21, 2026. At this time, the FDA has classified this as a Class II recall, which indicates that while the violation is not likely to cause serious adverse health consequences or death, it is significant enough to require corrective action due to potential contamination risks in the raw materials used during production.
To summarize, if you have a 2-ounce jar of Broadway Joe's Pain Cream containing Histamine Dihydrochloride 0.025%, 1500mg CBD Isolate, and 1000mg Hempseed oil, with an NDC of 83088-8120-5 and a UPC of 8 50041 64003 7, you must check the lot number on the bottom or side of the jar. If the lot number matches T1110, T1111, T1112, T1113, or T1114, and you reside in or recently visited Colorado, your product is part of this recall. The remedy for this issue has not yet been stated by the agency, so consumers are advised to hold onto their product documentation until further instructions are provided.
The hazard, explained
When the FDA classifies a product recall as involving Current Good Manufacturing Practice (CGMP) deviations related to raw material contamination, they are identifying a breakdown in the foundational safeguards that keep medicines and supplements safe. In plain terms, CGMP regulations require manufacturers to maintain strict control over every ingredient from the moment it arrives at their facility until the final product is shipped. The hazard here isn't necessarily that the active ingredients—like the CBD isolate or hempseed oil—are inherently dangerous when pure. Rather, the risk stems from the possibility that these raw materials may have been exposed to unwanted contaminants before they were even mixed into the cream.
To understand why this matters, it helps to look at what "contamination" can actually mean in a manufacturing context. Raw materials for topical products like pain creams are often derived from agricultural sources or complex chemical processes. If the facilities handling these ingredients are not adequately cleaned, or if storage conditions allow for moisture, heat, or pest exposure, foreign substances can enter the supply chain. This could include microbial pathogens like bacteria or mold, which thrive in damp environments and can cause serious infections, especially when applied to skin that may be irritated or broken. It could also involve heavy metals, residual solvents from extraction processes, or allergens from other products handled in the same facility.
The specific concern with Broadway Joe's Pain Cream is that the integrity of the raw materials was compromised. Even though the product contains beneficial compounds like Histamine Dihydrochloride and CBD, these do not sterilize the mixture. If a contaminant was present in the hempseed oil or another base ingredient, it would remain in the final 2-ounce jar. When you apply this cream to your skin, your body absorbs these substances directly. While topical application is generally safer than ingestion, contaminated topicals can lead to localized skin infections, allergic reactions, or systemic issues if pathogens bypass the skin's natural barrier.
This is why the FDA took action. They don't wait for a confirmed illness to issue a Class II recall in many cases; they act when the potential for harm is significant and widespread. A Class II classification indicates that use of the product could cause temporary health problems or pose a slight threat of a more serious nature. By recalling lots T1110 through T1114, the FDA is addressing a specific window of production where quality controls failed. The goal is to remove these potentially compromised jars from circulation before anyone applies them, preventing what could have been a silent health risk turning into a visible medical issue.
Who is most at risk
To understand who faces the greatest potential harm from this recall, we first need to look at the nature of the product itself and the specific type of failure that triggered the FDA’s action. Broadway Joe's Pain Cream is a topical formulation designed for localized relief, typically used by adults managing chronic joint pain, muscle soreness, or inflammation. Because it is applied directly to the skin, the primary group affected are those who purchase and apply this cream regularly. The recall stems from Current Good Manufacturing Practice (CGMP) deviations related to the potential contamination of raw materials. This means that while the product may look and feel normal, there is a possibility that harmful bacteria, fungi, or other unwanted substances were introduced during the production process before the final jar was sealed. Therefore, anyone who has applied this cream to broken skin, open wounds, or sensitive areas like the face or groin is at a higher level of risk for adverse reactions than someone who uses it on intact, healthy skin.
The specific population most vulnerable to these risks includes individuals with compromised immune systems. For people undergoing chemotherapy, those living with HIV/AIDS, organ transplant recipients, or anyone managing autoimmune conditions like rheumatoid arthritis or lupus, the body’s natural defense mechanisms are already working overtime. Introducing even a minor amount of microbial contamination through a topical application can bypass the skin’s barrier and lead to localized infections that quickly become systemic. For these individuals, what might be a mild irritation for someone else could escalate into a serious infection requiring medical intervention. Additionally, elderly users often have thinner, more fragile skin that is less effective at acting as a protective barrier. This makes it easier for contaminants to penetrate deeper into the tissue, increasing the likelihood of inflammation or secondary bacterial infections.
Another critical group to consider includes those with known sensitivities to the ingredients listed in the product, such as Histamine Dihydrochloride, CBD Isolate, or Hempseed oil. While these ingredients are generally safe for many, the potential contamination mentioned in the FDA notice introduces an unpredictable variable. A person who is not normally sensitive to hemp derivatives might react differently if the raw material was contaminated with allergens or irritants during processing. Furthermore, because the product is distributed in Colorado, local users should be particularly vigilant. If you are caring for a family member who uses this cream for pain management, you must monitor them closely for any signs of unusual skin redness, swelling, warmth at the application site, or fever. These could be early indicators that the raw material issue has resulted in a biological hazard that requires immediate medical attention rather than simple disposal of the product.
It is also important to note that while the recall is classified as a Class II action, indicating a temporary or medically non-life-threatening situation for most users, "Class II" does not mean "low risk" for everyone. It signifies that use of the product could cause temporary health problems or pose a slight threat of a serious nature. Therefore, the risk is not uniform; it is heavily dependent on the individual’s health status and the condition of their skin at the time of application. Pregnant or breastfeeding individuals should also exercise extreme caution, as the systemic absorption of contaminants in topical products is not fully understood, and avoiding any potential exposure is the safest course of action until more information becomes available from the manufacturer, Lexia LLC.
How to tell if you have the recalled item
Before you take any action or contact the manufacturer, you need to be absolutely certain that the jar of cream sitting on your bathroom counter or in your medicine cabinet is part of this specific recall. Because "Broadway Joe's Pain Cream" may sound like a generic name and because recalls are often limited to very specific batches, guessing can lead to unnecessary worry or, worse, ignoring a genuine safety issue. The FDA recall notice provides a precise set of identifiers that act as your checklist. You must verify every single point below; if even one detail does not match, your product is likely safe from this particular recall event.
First, examine the packaging closely. You are looking for a 2 oz-jar. This size specification is critical because manufacturers often produce pain creams in various volumes, such as 1 oz tubes or 4 oz tubs. Only the 2 oz jars are included in this recall. Next, look at the label content. The product must be identified as "Broadway Joe's Pain Cream" containing Histamine Dihydrochloride 0.025%, 1500mg CBD Isolate, and 1000mg Hempseed oil. If your jar lists different active ingredients or concentrations, it is not part of this recall.
The most important step is checking the lot number and expiration date printed on the jar or its box. The recall affects exactly five specific lots. You must find one of the following lot numbers: T1110, T1111, T1112, T1113, or T1114. Each lot number corresponds to a specific expiration date printed alongside it:
- Lots with expiration date 1/7/2027
- Lots with expiration date 1/9/2027
- Lots with expiration date 1/16/2027
- Lots with expiration date 1/17/2027 (appearing for both T1113 and T1114)
If your expiration date falls outside these January 2027 dates, or if the lot number does not start with "T11," this product is not affected. Additionally, verify the National Drug Code (NDC) and Universal Product Code (UPC). The recalled items carry NDC 83088-8120-5 and UPC 8 50041 64003 7. While these codes are harder to read on a jar, they can be useful if you have the original receipt or packaging box. Finally, while distribution was limited to Colorado, the recall applies regardless of where you currently possess the item. If you bought it in Colorado and moved, or received it as a gift, the risk remains the same. Double-check these five identifiers against your jar before proceeding.
What to do — step by step
If you have purchased Broadway Joe's Pain Cream from Colorado, the first and most critical action you need to take is to stop using the product immediately. Because this recall is driven by Current Good Manufacturing Practice (CGMP) deviations involving potential contamination of raw materials, continuing to apply the cream to your skin poses an unnecessary health risk. Even if the product looks normal and smells fine, microscopic contaminants introduced during manufacturing are not visible to the naked eye. Your safety depends on removing the source of that potential hazard from your routine without delay. Please do not wait for symptoms to appear; prevention is far simpler than treatment.
Once you have set the jar aside, you need to verify exactly which batch you own. The FDA notice specifies that this recall affects specific lot numbers: T1110, T1111, T1112, T1113, and T1114. You should carefully check the bottom or side of your 2 oz-jar for these codes. It is also wise to double-check the expiration dates, which range from January 7, 2027, to January 17, 2027, depending on the specific lot. If your jar does not match one of these lot numbers, it is likely safe to continue using it, but if you are unsure or cannot read the label clearly, the safest course of action is still to treat it as part of the recall.
Here comes the tricky part: the official FDA recall announcement for Broadway Joe's Pain Cream does not currently state a specific remedy. This means there are no formal instructions provided by the manufacturer regarding returns, refunds, or exchanges at this time. While it is highly unusual for a Class II drug recall to lack a clear consumer directive, we must rely on the facts as they stand. Because no return address or customer service phone number was included in the official filing, you cannot process a refund through a formal channel right now. Do not attempt to mail the product back to an unknown address found on unofficial websites, as this could lead to privacy risks or lost packages.
In the absence of a stated remedy, your best course of action is to document what you have. Take clear photographs of the front label, the lot number, and the expiration date. This documentation will be invaluable if Broadway Joe's or Lexia LLC releases further instructions in the coming days or weeks. Keep the product in a safe place where children or pets cannot access it, but do not throw it in your regular household trash yet, as improper disposal could allow others to retrieve it. Monitor official FDA resources and the company’s website for updates on how to proceed with refunds or replacements. Until then, prioritize your health by avoiding use and staying informed through official channels rather than rumor.
Finally, if you experience any unusual skin reactions such as redness, itching, or swelling after using this product before you learned of the recall, please consult a healthcare professional. Bring your documentation with you to the appointment so they can verify the exposure. While no incidents have been reported in connection with this specific lot, the potential for contamination means that medical advice should not be ignored if symptoms arise. Stay calm, stay informed, and wait for official guidance on how to resolve your purchase.
Your refund, repair, or replacement options
When you receive news that a product you have purchased is part of an official recall, the most immediate and practical question is often, "What do I get out of this?" In the case of the recent FDA recall involving Broadway Joe's Pain Cream, it is important to approach your options with clarity and patience. The official recall documentation for this specific batch of topical pain relief cream does not explicitly outline a standard remediation pathway, such as automatic refunds, store credits, or direct replacements from the manufacturer. This absence of stated remedy terms can feel uncertain, but it is a common occurrence in regulatory actions involving Good Manufacturing Practice (CGMP) deviations rather than immediate physical injury reports.
Because the recall was issued due to potential contamination of raw materials during production, the primary goal of the FDA and Lexia LLC is to remove these items from circulation to prevent any adverse health outcomes. However, the financial resolution—whether that be a refund for your purchase or an exchange for a safe, uncontaminated product—is not automatically mandated in the public recall notice. This means you must take the initiative to contact the responsible parties directly. The recall was produced for Broadway Joe's in Franklin, Tennessee, and distributed within Colorado. While specific phone numbers or email addresses are not listed in the provided facts, your first step should be to locate the original receipt or proof of purchase. This documentation is crucial because it establishes your transaction with the retailer or the brand itself.
If you purchased the cream directly from Broadway Joe's, reach out to their customer service department using any contact information available on their official website or your order confirmation email. Explain that you possess a lot number (T1110 through T1114) subject to this recall and inquire about their specific return policy. They may offer a full refund to the original payment method, store credit, or a replacement product once they have verified the safety of new inventory. If you bought the item from a third-party retailer in Colorado, contact that store's customer service department as well. Retailers often have their own protocols for handling recalled goods, which might include accepting the item back for a refund regardless of the manufacturer's direct instructions.
It is vital to keep your records organized during this process. Save copies of all emails, note down the names of any representatives you speak with, and record the dates of your communications. Since the remedy is not stated in the recall facts, your ability to secure a refund or replacement depends entirely on the goodwill and policies of the seller or manufacturer. Do not attempt to use the product while waiting for a resolution, as the potential contamination risk remains until the FDA confirms the issue is resolved. Patience and clear communication with the point of sale are your best tools for navigating this situation.
What can happen if you ignore it
When a recall is issued for Class II reasons, it signals a situation that is unlikely to cause serious adverse health consequences, but could potentially result in temporary medical problems or require corrective action. However, ignoring the warning and continuing to use Broadway Joe's Pain Cream carries risks that extend beyond simple disappointment. The core issue identified by the FDA involves Current Good Manufacturing Practice (CGMP) deviations related to the potential contamination of raw materials. While the recall notice does not specify exactly what contaminants were found or suspected, "potential contamination" in a topical product is never a minor oversight. It implies that the strict controls designed to keep a product pure and safe were compromised during production.
If you continue to apply this cream to your skin, you are bypassing the safety net intended to protect you from unknown impurities. Raw materials for cosmetics and over-the-counter drugs must be tested and verified for purity before they enter the manufacturing line. When that verification fails or is skipped, foreign particles, microbial growth, or chemical residues can remain in the final jar. Even if you do not feel an immediate reaction, your skin acts as a barrier, but it is not impenetrable. Applied topically, especially on areas that may have micro-abrasions or inflammation from pain, compromised ingredients can lead to contact dermatitis, rashes, itching, or localized infections. For individuals with sensitive skin or pre-existing conditions, the reaction could be more severe and longer-lasting.
Furthermore, there is the uncertainty of what lies within that 2 oz-jar. Because the remedy for this specific recall has not been stated by the manufacturer or the FDA, you cannot assume that a simple patch test will make the product safe to use in the future. The contamination might be inconsistent across the batch; one jar might seem fine while another is heavily compromised. By ignoring the recall, you are essentially gambling with your health based on incomplete information. You are trusting that the deviation was minor when it could have been significant. In the worst-case scenario, using a product with contaminated raw materials can lead to systemic issues if the skin barrier is breached or if you inadvertently transfer the product to your eyes or mouth.
It is also important to consider the broader impact of ignoring safety alerts. When consumers continue to use recalled items, it delays the manufacturer's ability to fully assess the scope of the problem and implement corrective measures for future batches. It keeps potentially unsafe materials in circulation longer than necessary. While the risk of severe injury may be low given the Class II classification, the principle remains: if a regulatory body flags a product for CGMP violations, the integrity of that product is no longer guaranteed. Your skin deserves products that have met rigorous safety standards, not those that have bypassed them. Taking the time to dispose of or return these jars is a small effort that eliminates even the smallest possibility of harm from unknown contaminants.
Staying safe: broader tips
When you are dealing with topical pain relief products or any over-the-counter medication, your safety relies heavily on consistent, everyday habits that go far beyond a single recall notice. While the recent FDA action regarding Broadway Joe's Pain Cream highlights specific gaps in manufacturing standards, the broader lesson applies to how we source and store all health-related items. One of the most effective ways to protect yourself is to buy only from reputable, established retailers or directly from verified manufacturers. This simple step significantly reduces the risk of encountering products that have bypassed Current Good Manufacturing Practices (CGMP), which are the baseline standards designed to ensure that drugs are consistently produced and controlled to quality standards.
Proper storage is another critical, yet often overlooked, aspect of product safety. Even if a product has passed initial manufacturing checks, improper storage can compromise its integrity over time. For creams, ointments, and CBD-infused topicals, this means keeping them in a cool, dry place away from direct sunlight and extreme temperature fluctuations. Heat and humidity can accelerate the degradation of active ingredients like histamine dihydrochloride or CBD isolate, potentially altering their effectiveness or creating an environment where microbial growth could occur if the packaging seal is compromised. Always check the expiration date not just at the time of purchase, but periodically as you use your supplies. Using a product past its prime can mean reduced potency or, in rare cases, chemical breakdown that might irritate the skin.
Staying informed is your best defense against unexpected hazards. The FDA issues thousands of warnings each year, and while most are routine, some address serious safety concerns. Make it a habit to subscribe to email alerts from the FDA’s official website or follow their verified social media channels. You should also consider registering your products with the manufacturer when possible; this ensures that if a batch-specific issue arises, you can be contacted directly rather than having to hunt for information yourself. Additionally, always read the label carefully before use. Look for clear ingredient lists, manufacturing dates, and lot numbers. If a product lacks this transparency, it is a red flag worth investigating further.
Finally, trust your senses. If a cream smells off, has changed texture, or shows signs of separation that do not resolve with gentle mixing, do not risk using it. Your body’s reaction to contaminated or degraded products can vary widely, from mild skin irritation to more severe allergic responses. By combining cautious purchasing habits, proper storage, and active engagement with safety updates, you create a robust layer of protection that keeps you safe regardless of what the news cycle brings.