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en Español   Laboratory tests indicate elevated levels of lead The U.S. Food and Drug Administration is warning consumers not to use “Bentonite Me Baby” by Alikay Naturals because of a potential lead poisoning risk. “Bentonite Me Baby” is sold online and in retail outlets, including Target stores, Amazon.com, and Sally Beauty Supply, and is marketed as medicinal clay. The product’s labeling indicates that it can be ingested and applied topically to hair and skin for a variety of conditions. Consumers should not purchase or use “Bentonite Me Baby.” Anyone who has used this product or provided it to a child should consult a Health care professional immediately. FDA laboratory analysis of the product found elevated lead levels.  Exposure to lead can cause serious damage to the central nervous system, the kidneys, and the ...

[8/21/2017] The U.S. Food and Drug Administration is warning consumers not to drink Longjack Coffee, in addition to other instant coffee products that have been recalled recently – Kopi Jantan Tradisional Natural Herbs Coffee, CaverFlo Coffee, and AMPT Coffee. These products are made in Malaysia, and promoted and sold online for sexual enhancement.  These products are labeled to contain instant coffee, non-dairy creamer, and other ingredients. However, FDA laboratory analysis confirmed: CaverFlo Coffee and AMPT Coffee contain undeclared sildenafil and tadalafil;  Longjack Coffee and Kopi Jantan Tradisional Natural Herbs Coffee contain undeclared desmethyl carbodenafil, an analogue of sildenafil; and All of these products contain undeclared milk. Sildenafil and tadalafil are the active ingredients in the FDA-approv...

[3/16/18] FDA is alerting consumers of a voluntary recall of Bayer’s Alka-Seltzer Plus product s due to labeling errors . Bayer is voluntarily recall ing Alka-Seltzer Plus® packages that: Were sold only in the U.S. at Walmart, CVS, Walgreens and Kroger (including Dillons Food Stores, Fred Meyer, Fry's Food Stores, Ralphs, King Soopers and Smith's Food and Drug) after February 9, 2018. Can be identified by checking the Bayer logo located on the lower left corner of the front of the carton. If the logo has an orange or green background, the product is included in the recall. Consumers who purchased packages of Alka-Seltzer Plus that are being recalled should stop using the product immediately. Consumers should contact their physician or healthcare provider if they experience any problems that may be related to...

FDA lab confirmed high levels of microbial contamination in company’s Pasta De Lassar Andromaco diaper rash treatment En Español [3/30/2018] The U.S. Food and Drug Administration is alerting consumers of a voluntary recall of a topical drug product Pasta De Lassar Andromaco zinc oxide diaper rash treatment, made by Industria Farmacéutica Andrómaco, Toluca, Mexico, and distributed by MarcasUSA LLC, El Segundo, California. FDA laboratory analysis confirmed that Pasta De Lassar Andromaco is contaminated with high levels of yeast, mold, and bacteria. This is especially concerning because Pasta De Lassar Adromoca is labeled for use to relieve diaper rash, where irritated skin can become infected. Therefore, consumers and caregivers should not use this product due to possible microbial contamination that may cause infection...

[7/5/2018] The Food and Drug Administration (FDA) is advising consumers not to use Blissful Remedies kratom product s sold by World Organix LLC, Las Vegas, Nevada. FDA laboratory analysis found that the product s are contaminated with high counts of various bacteria that can cause infections, including Salmonella, Clostridium difficile, Klebsiella pneumoniae and Pseudomonas aeruginosa. Blissful Remedies announced a recall on June 30, 2018. FDA is concerned this recall does not include all lot numbers of the affected products. FDA has received reports of adverse events associated with kratom product s. There are no proven medical uses for kratom and the public is strongly discouraged from consuming kratom . Kratom is an inherently addictive product that can cause harm. FDA encourages Health care professionals and ...

[8/31/2018] The Food and Drug Administration is alerting consumers and Health care professionals to a voluntary recall of certain lots of HelloLife (Grand Rapids, Michigan) drug products, Neuroveen, Respitrol, Thyroveev and Compulsin. The products labeled as homeopathic are being recall ed due to microbial contamination.   According to HelloLife, Neuroveen was tested and found to be contaminated with Staphylococcus saprophyticus and Burkholderia cepacia . Compulsin was tested and found to be contaminated with Burkholderia cepacia . Respitrol and Thyroveev are still pending bacterial identification. Administration or use of drug products with microbial contamination could potentially result in increased infections that may require medical intervention, and could result in infections that could be life threatening t...

[9/7/2018] The Food and Drug Administration is alerting consumers and Health care professionals to a voluntary recall of all water- and alcohol-based Beaumont Bio Med Inc. (Grand Rapids, Michigan) drug products . These products , labeled as homeopathic, are being recall ed due to microbial contamination at the manufacturing facility.  Administration or use of drug products with microbial contamination could potentially result in increased infections that may require medical intervention, and could result in infections that could be life threatening to certain individuals. These products were manufactured at the King Bio, Inc. facility in Asheville, North Carolina. Previously, FDA alerted consumers of HelloLife’s voluntary recall of drug products labeled as homeopathic, also manufactured by King Bio. Health care pro...

[9/14/2018] The U.S. Food and Drug Administration is alerting consumers not to use any products made by Years to Your Health of Irving, Texas. FDA is concerned these products could put consumers at risk for serious infection because they are made in a facility with poor manufacturing practices. Years to Your Health markets hundreds of products online and in its retail store. FDA recently conducted an inspection at Years to Your Health following a warning letter the agency issued in August 2017. FDA investigators observed several repeat violations of federal law that could lead to consumer harm. For example, the company does not perform any testing of incoming ingredients used to manufacture the drug products or test finished drug products. This could result in high-risk products, such as eyewash, being contaminated ...

[9/14/2018] The Food and Drug Administration is alerting consumers and Health care professionals about a voluntary recall of certain lots (1138, 1139, 1146, and 1160) of NeoRelief distributed by BioLyte Laboratories (Grand Rapids, Michigan). NeoRelief is labeled as a homeopathic topical for the temporary relief of occasional muscle cramps, restlessness and twitching and is being recall ed due to microbial contamination at the active ingredient manufacturing facility. Administration or use of drug products with microbial contamination could potentially result in increased infections that may require medical intervention. Some of NeoRelief’s active ingredients were manufactured at a King Bio Inc. facility in Asheville, North Carolina. Previously, FDA alerted consumers of HelloLife’s voluntary recall of drug products l...

[10/11/2018] The Food and Drug Administration is alerting consumers about a voluntary recall of all lots with expiration dates from October 2018 to July 2022 of Sprayology’s water-based homeopathic product line for human use. These products are labeled as a homeopathic and are being recall ed due to microbial contamination at the King Bio Inc. manufacturing facility in Asheville, North Carolina. Administration or use of drug products with microbial contamination could potentially result in increased infections that may require medical intervention. Previously, FDA alerted consumers to four other voluntary recall s related to King Bio’s recall : Health care professionals and patients should report any adverse events associated with Sprayology's products to the FDA’s MedWatch Adverse Event Reporting pr...

[11/8/2018] The Food and Drug Administration is alerting consumers about a voluntary recall of all lots of Puriton Eye Relief Drops, 0.5 oz. (15 ml) bottle. These product s are labeled as a homeopathic and are being recall ed due to non -sterile production conditions at the manufacturing facility. Consumers should stop using this product and contact their physician or Health care provider if they experience any problems that may be related to using this product . Puriton Eye Relief Drops are over-the-counter homeopathic eye drops marketed for the temporary relief of burning and irritation due to eye dryness and eye discomfort due to minor irritations or to exposure to wind or sun. Kadesh, Inc., is voluntarily recalling all non-expired lots of Puriton Eye Relief Drops. The company distributed the product nation...

[12/11/2018] The U.S. Food and Drug Administration is alerting consumers , particularly males, not to purchase or use two e-liquid s sold by HelloCig Electronic Technology Co. Ltd. that contain undeclared prescription drugs tadalafil and/or sildenafil. FDA laboratory analysis confirmed “E-Cialis HelloCig E-Liquid” contains the undeclared drugs sildenafil and tadalafil, and “E-Rimonabant HelloCig E-Liquid” contains the undeclared drug sildenafil. These undeclared ingredients may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Sildenafil and tadalafil are the active pharmaceutical ingredients in FDA-approved prescription drugs used to treat e...

[6/25/2019] FDA is warning consumers not to use products marketed by Kratom NC, of Wilmington, North Carolina, due to microbial contamination. FDA laboratory analysis of Kratom NC’s raw materials and finished products identified various microorganisms, including Klebsiella pneumoniae , Enterobacter spp. and Escherichia sp. These organisms may cause serious illnesses in vulnerable patient populations. FDA contacted Kratom NC on June 14 to recommend the company recall all of its products currently on the market. However, the company has not taken any action to recall these potentially dangerous products. The agency recently issued a warning letter to Kratom NC for illegally selling unapproved, misbranded kratom-containing drug products with unproven claims about their ability to treat or cure opioid addiction and...

en Español [10/11/2019]  FDA advises consumers not to use Rompe Pecho EX and Rompe Pecho CF cough syrups distributed by Efficient Laboratories, Inc., Miami, Florida, due to microbial contamination risks. These are over-the-counter medicines for children six years and older. FDA recommends consumers stop using these medicines and dispose of them. These contaminated cough medicines could potentially cause illness. On October 9, 2019, FDA recommended that Efficient Laboratories recall Rompe Pecho EX and Rompe Pecho CF cough syrups. To date, the company has not taken action to remove these potentially dangerous medicines from the market. FDA is not aware of any reports of adverse events associated with these medicines at this time. Consumers who use Rompe Pecho EX and Rompe Pecho CF cough syrups and have concern...

Spanish version Update [6/29/2020] FDA is alerting consumers of Saniderm Products and UVT Inc.’s voluntary recall of Saniderm Advanced Hand Sanitizer. Following FDA’s recommendation, two distributors – Saniderm Products and UVT – agreed to recall Saniderm Advanced Hand Sanitizer packaged in 1-liter plastic bottles and labeled with “Made in Mexico” and “Produced by: Eskbiochem SA de CV.” The UVT hand sanitizer is labeled with lot number 0530 and an expiration date of 04/2022. The Saniderm Products hand sanitizer is labeled with lot number 53131626 and “Manufactured on April/1/20.” [6/19/2020] FDA advises consumers not to use any hand sanitizer manufactured by Eskbiochem SA de CV in Mexico, due to the potential presence of methanol (wood alcohol), a substance that can be toxic when absorbed through the skin or in...

Need help now? Call 9-1-1 if the person is unconscious or has trouble breathing. Call Poison Help at 800-222-1222 to connect to your local poison center. Learn more at poisonhelp.hrsa.gov/. Hand sanitizers consumers should not use Spanish version 10/12/2021: FDA In Brief: FDA Withdrawing Temporary Guidances for Alcohol-Based Hand Sanitizers [10/12/2021] Go to FDA in Brief 10/4/2021: UPDATE - FDA advises consumers not to use certain artnaturals hand sanitizers [10/28/2021] FDA is alerting health care professionals and consumers of artnaturals voluntary recall of limited batches of 8 oz bottles of Scent Free Hand Sanitizer. [10/4/2021]  FDA has tested certain artnaturals scent free hand sanitizer labeled with “DIST. by artnaturals ...