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Shedding Light on the Risks
& Benefits of Medications FDA Recalls and Warnings: Zicam Nasal Swabs Recalled, Foreign Pills Found in Trazodone Bottles
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Get the latest FDA updates on medication recalls, manufacturing violations, and quality concerns that could affect your prescriptions
September 14, 2026
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Welcome to the FDA Recalls and Warnings Update, a series dedicated to keeping you informed about the latest medication recalls, manufacturing violations, and quality concerns affecting your prescriptions. In this installment, we’re looking at quality concerns affecting several widely used products, including Zicam Cold Remedy Nasal Swabs and trazodone—as well as a sunscreen that may not provide the protection promised on its label. One of the recalls also involves an unusual problem we’ve seen before: the discovery of foreign pills in bottles of prescription medication.
Also included are recalls involving Broadway Joe’s Pain Cream, buprenorphine, ramipril, and Trokendi XR.
Consumers may wish to check the linked enforcement report for the list of affected product lot numbers and expiration dates. For prescription drugs that don’t include a lot number on the packaging, consumers may check with their pharmacist to see whether a medication is affected by the recall.
How To Read This Report
The Food and Drug Administration (FDA) categorizes product recalls in its Enforcement Report database based on the level of health risk, labeling them as Class I, II, III, or “not yet classified.”
While the database includes drugs, food, cosmetics, medical devices, biologics, tobacco, and veterinary products, this report only covers selected drug recalls.
- Class I recalls are the most serious. In these situations, there is “reasonable probability that the use of or exposure to a product will cause serious adverse health consequences or death.”
- Class II recalls are for drugs that may cause temporary or medically reversible adverse health consequences or where use of the product is unlikely to result in serious adverse health consequences.
- Class III recalls are the least serious. Use of the product is not likely to cause adverse health consequences.
Drug manufacturers, supplement companies, and medical device makers may receive a Warning Letter from the FDA if they commit serious violations of federal regulations. This letter comes from an overseeing FDA office, such as the Center for Drug Evaluation and Research. Common violations include poor manufacturing practices, false product claims, selling misbranded items, or marketing unapproved products. The letter gives the recipient a chance to correct the issues and requires a response, usually within 15 days.
FDA Import Alerts notify field staff and the public when the agency has enough evidence to detain products without physical examination (DWPE) due to suspected violations of FDA laws, including violations of “current good manufacturing practices for finished pharmaceuticals” or unapproved new drugs. The violations lists are arranged by type of violation, then by country and then by the importing company. In some cases, Import Alerts may be linked to Warning Letters for issues like manufacturing violations.
Drug Recalls
Broadway Joe’s Pain Cream (Histamine Dihydrochloride with CBD Isolate and Hempseed Oil)
Company: Lexia LLC
Manufacturing Location: Not specified; produced for Broadway Joe’s, Franklin, Tennessee
Scope: 2,400 2 ounce jars containing 1,500 mg CBD isolate and 1,000 mg hempseed oil; 1,200 4 ounce jars containing 3,000 mg CBD isolate and 2,000 mg hempseed oil; distributed in the state of Colorado.
Drug Purpose: Over-the-counter topical pain relief cream for temporary relief of minor muscle and joint aches and pains for age 13 and up.
Recall Reason: Current Good Manufacturing Practice (cGMP) deviations, which could affect product quality; potential contamination of raw material.
Essential Extras: Histamine dihydrochloride is the approved active ingredient in this topical analgesic cream. The product also contains a CBD (cannabidiol) ingredient, which is cannabis-derived and is not FDA-approved. The FDA has an information guide about CBD-containing products. It says it is evaluating the safety of CBD in dietary, topical, and other formulations. This product’s brand is connected to football legend Joe Namath, who has the nickname “Broadway Joe.”
Recall Initiation Date: August 21, 2026
Recall Level: Class II
Link: FDA Enforcement Report
Buprenorphine Sublingual Tablets (generic for Subutex)
Company: American Health Packaging
Manufacturing Location: Wilson, North Carolina, by Knoa Pharma and packaged by American Health Packaging, Columbus, Ohio (see “Essential Extras” below)
Scope: 10,953 30-count cartons (3 x10 blister packs) of 2 mg tablets
Drug Purpose: Treats opioid dependence as part of a comprehensive treatment program that includes counseling and behavioral support.
Recall Reason: Unspecified labeling mix-up
Recall Initiation Date: August 19, 2026
Recall Level: Not yet classified
Essential Extras: Manufacturing location information was obtained from the recalled product drug label, which indicated the product is from Rhodes Pharmaceuticals, which specified Knoa Pharma as the manufacturer. Knoa Pharma is owned by the Knoa Foundation, a non-profit formed as a result of Purdue Pharma’s $7.4 billion criminal penalty and bankruptcy settlement related to its role in the nation’s opioid crisis.
Knoa Pharma’s mission is to manufacture medications, including opioid products, safely and responsibly to address public health needs. Knoa also makes and sells opioid addiction treatment products as part of its mission to sell overdose reversal and addiction treatment medicine at or below cost. This recall is attributed to a labeling error that occurred at American Health Packaging or along the product’s supply chain, not to any manufacturing process.
Link: FDA Enforcement Report
THE ONE SPF 50 Invisible Sunscreen Gel
Company: Allies Group Inc.
Manufacturing Location: United States; distributed by Allies Group Pte Ltd, Singapore
Scope: Five tube sizes (50 mL: 29,014 tubes; 20 mL: 23,941 tubes; 90 mL: 2,149 tubes; 3 mL single-use sachets: 27,492 packets). Active ingredients are avobenzone 3%, homosalate 7%, octocrylene 10%, and octisalate 5%.
Drug Purpose: Topical sunscreen used to help prevent sunburn and protect skin from ultraviolet rays.
Recall Reason: Subpotent; testing indicated the product may not reliably provide the SPF 50 protection stated on the label.
Recall Initiation Date: August 14, 2026
Recall Level: Class II
Link: FDA Enforcement Report
Ramipril Capsules (generic for Altace)
Company: Hikma Pharmaceuticals USA Inc.
Manufacturing Location: Columbus, Ohio by West-Ward Columbus Inc., for Exelan Pharmaceuticals
Scope: 25,970 100-count bottles of 10 mg capsules; 2,384 500-count bottles of 10 mg capsules
Drug Purpose: Angiotensin-converting enzyme (ACE) inhibitor used to treat high blood pressure and reduce the risk of heart attack, stroke, and cardiovascular death in certain high-risk patients. It is also used in some people with heart failure after a heart attack.
Recall Reason: Failed impurities/degradation specifications; an out-of-specification result was obtained for the process impurity dicyclohexylurea (DCU); this could affect product quality.
Recall Initiation Date: August 24, 2026
Recall Level: Class II
Link: FDA Enforcement Report
Trazodone Hydrochloride Tablets (generic for Desyrel)
Company: Teva Pharmaceuticals USA, Inc.
Manufacturing Location: Zagreb, Croatia by Pliva Hrvatska d.o.o. for Teva Pharmaceuticals
Scope: 175,392 100-count bottles of 50 mg tablets
Drug Purpose: Antidepressant; often used off-label for insomnia.
Recall Reason: Bottles contained unspecified foreign tablets/capsules.
Recall Level: Class II
Essential Extras: A similar recall by Granules Pharma for Trazodone 50 mg occurred in January 2026; metoprolol tablets were mistakenly included in some bottles.
Link: FDA Enforcement Report
Trokendi XR (topiramate) Extended-Release Capsules
Company: Supernus Pharmaceuticals, Inc.
Manufacturing Location: Winchester, Kentucky by Catalent Pharma Solutions
Scope: 11,304 30-count bottles, 50 mg strength capsules
Drug Purpose: Treats epileptic seizures; Used to help prevent migraines.
Recall Reason: Failed dissolution specifications; the capsule may not release the drug properly.
Recall Initiation Date: August 31, 2026
Recall Level: Class III
Essential Extras: Supernus initiated a similar recall in July 2026 for 30 mg Trokendi XR capsules.
Link: FDA Enforcement Report
Zicam Cold Remedy Medicated Nasal Swabs, With Cooling Menthol And Eucalyptus
Company: Church & Dwight Co., Inc.
Manufacturing Location: Unspecified location by a contract manufacturer; distributed by Church & Dwight, Ewing New Jersey
Scope: 318,600 cartons; 20 single-use swabs per carton
Drug Purpose: Zinc-free homeopathic cold-remedy nasal swabs used to temporarily relieve common cold symptoms.
Recall Reason: Manufacturing quality problems (Current Good Manufacturing Practice deviations); an FDA inspection of the contract manufacturer identified out-of-limit results during microbiological testing. This could potentially lead to microbial contamination.
Recall Initiation Date: August 10, 2026
Recall Level: Class II
Essential Extras: In June 2025, a Class I recall was issued for Zicam-brand and Orajel-brand swab products due to microbial contamination.
Link: FDA Enforcement Report
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