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 highlighting recalls for the ADHD medication atomoxetine, seven over-the-counter acne treatments, and Vitality, a male enhancement dietary supplement.
This installment also highlights FDA warnings about Advance King capsules illegally marketed to treat joint pain and topical lidocaine medications illegally marketed to relieve pain associated with certain cosmetic procedures, such as microdermabrasion, laser hair removal, tattooing and piercing.
How to Read This Report
This report is prepared using the most recent information posted in the FDA’s Enforcement Reports Database (for recalls), Warning Letters Database (for warning letters), and Drug Imports Alerts Database (for drug importers subject to import bans). Not all new entries to the databases are included in this report. Selected entries are chosen based on the type of product and the potential safety impact of the recall or warning.
Recall announcements and warnings are simplified to improve clarity and accessibility. In some cases, additional sources such as company statements, FDA press releases, and industry publications may provide further details. The primary sources for this report include:
Recalls (Enforcement Reports Database)
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.
Warning Letters (Warning Letters Database)
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.
Drug Imports Alerts Database
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
Atomoxetine capsules (generic for Strattera)
Company: Glenmark Pharmaceuticals; Glenmark product also offered by NorthStar Rx LLC
Manufacturing Location: Goa, India
Drug Description: Treats ADHD (attention-deficit/hyperactivity disorder)
Scope: More than 1.5 million bottles, ranging in strength from 10 to 100 milligrams
Recall Reason: Product contains unacceptable levels of N-nitroso atomoxetine.
Risk Statement: N-nitroso atomoxetine, like other nitrosamines, is a possible cancer-causing chemical.
Impact of Recall: Unlikely to cause shortages of atomoxetine as other suppliers are available.
Essential Extras: Nitrosamine impurities occur due to manufacturing process problems.
Recall Initiation Date: January 29, 2025
Link: FDA Enforcement Report
This recall is directed at retail suppliers, not consumers. This means retailers are instructed to remove products from sale but does not specifically instruct consumers to take actions regarding products currently in their possession.
Acne Products
Products: Walgreens Acne Control Cleanser, Walgreens Tinted Acne Treatment Cream, Proactiv Skin Smoother Exfoliator, SLMD Benzoyl Peroxide Acne Lotion, Proactiv Emergency Blemish Relief Cream Benzoyl Peroxide 5%, La Roche-Posay Effaclar Duo Dual Action Acne Treatment, Zapzyt Acne Treatment Gel
Company: LaRoche, SLMD, Walgreens, ProActive, Zapzyt
Drug Description: Over-the-counter acne treatment products containing benzoyl peroxide
Recall Reason: Product contains elevated levels of benzene.
Risk Statement: Elevated exposure to benzene can increase the risk of cancer.
Essential Extras: More than 90% of benzoyl peroxide-containing acne products tested by the FDA did not contain elevated levels of benzene.
Announcement Date: March 11, 2025
Link: FDA Press Release
This recall is directed at retail suppliers, not consumers. This means retailers are instructed to remove products from store shelves and online marketplaces but does not specifically instruct consumers to take actions regarding products currently in their possession.
Dietary Supplement Recalls
Vitality Pills
Company: One Source Nutrition
Where It’s Sold: Various retailers; specific suppliers are not identified in the press release.
Product Description: Male enhancement dietary supplement
Recall Reason:This product contains sildenafil and tadalafil, the active ingredients found in FDA-approved prescription medications used to treat erectile dysfunction in men.
Risk Statement: Products containing sildenafil or tadalafil are classified as prescription drugs and must be prescribed by a healthcare provider. Tadalafil, in particular, can interact with nitrates found in certain medications (such as nitroglycerin), potentially causing a dangerous drop in blood pressure that may be life-threatening.
Essential Extras: Product does not have lot numbers or expiration dates. The product can be identified by a single pill in an orange and gray package with blue writing, or found in bottles containing six pills.
Announcement Date: March 3, 2025
Refer to FDA Press release for more information and product images.
Advance King Capsules
Company: Advance King
Where It’s Sold: www.naturistastore.com; possibly also sold in some retail stores.
Product Description: Supplement promoted and sold for joint pain
Warning Reason: Product contains dexamethasone, diclofenac, and methocarbamol, which are ingredients in FDA-approved prescription drugs.
Risk Statement: Dexamethasone is a corticosteroid commonly used to treat inflammatory conditions. Corticosteroid use can impair a person’s ability to fight infections and can cause high blood sugar levels, muscle injuries and psychiatric problems. Abrupt discontinuation can cause withdrawal symptoms.
Essential Extras: Consumers taking Advance King should immediately consult with their health care professional to safely discontinue use of this product.
Announcement Date: February 10, 2025
Link: FDA Press Release
Refer to FDA Press release for more information and product images.
Warning Letters: Unapproved and Misbranded Lidocaine Drugs
Companies: TKTX Company, SeeNext Venture Ltd, Tattoo Numbing Cream Co., Painless Tattoo Company, Dermal Source Inc., INKEEZE
Products and Websites:
- TKTX Company: TKTX Numb Maximum Strength Pain Reliever, Mithra+ 10% Lidocaine, TKTX During Procedure Numbing Gel 40% and J-CAIN cream [LIDOCAINE] 29.9%
Sold at: https://tktxcompany.com - SeeNext Venture, Ltd.: NumbSkin 5% Lidocaine Numbing Cream (15 grams), NumbSkin 5% Lidocaine Numbing Cream (30 grams) and NumbSkin 10.56% Lidocaine Numbing Cream
Sold at: https://numbskin.com/ - Tattoo Numbing Cream Co.: Signature Tattoo Numbing Cream and Miracle Numb Spray
Sold at:https://tattoonumbingcream.com/ - Sky Bank Media, LLC, doing business as Painless Tattoo Co.: Painless Tattoo Numbing Cream and Painless Tattoo Numbing Spray
Sold at: https://painlesstattoo.co/ - Dermal Source, Inc.: New & Improved Blue Gel, Superior Super Juice, Premium Pro Plus, Five-Star Vasocaine and Maximum Zone 1. Sold at:https://dermalsource.com/
- Indelicare, doing business as INKEEZE: Ink Eeze Original B Numb Numbing Gel, Ink Eeze B Numb Numbing Spray Black Label and Ink Eeze B Numb Numbing Foam Soap
Sold at: https://Inkeeze.com
Product Description: Topical creams, gels, and sprays marketed over-the-counter to relieve pain before, during or after certain cosmetic procedures, such as microdermabrasion, laser hair removal, tattooing and piercing.
Warning Reason: Lidocaine is present at higher concentrations than is permitted in non-prescription drug products. In some cases, prilocaine and epinephrine are also listed as active ingredients; these are not permitted as active ingredients in over-the-counter drugs.
Risk Statement: When lidocaine is applied over large areas of skin, particularly on irritated or broken skin, for prolonged periods of time, and when the skin is covered, it increases the amount of active ingredient that passes into the bloodstream and may cause serious injury. High concentrations of lidocaine intended to be used before or during certain cosmetic procedures could lead to increased absorption of the drug product through the skin, leading to serious injury such as irregular heartbeat, seizures and breathing difficulties. These products may also interact with medications or dietary supplements.
Essential Extras: Consumers are warned not to use these over-the-counter analgesic (pain relief) products. The FDA is aware of reports of adverse events related to these products and encourages consumers and health care professionals to report any adverse events with use of any drug to the MedWatch Adverse Event Reporting program.
Announcement Date: March 26, 2025
Link: FDA Press Release
Use specific company links above to read warning letters for specific details about the violations.
