FDA Recalls

September 17, 20245:23 pm

Bionpharma Inc. Issues Voluntary Nationwide Recall of Atovaquone Oral Suspension Due to Bacterial Contamination September 17, 2024 – Princeton, NJ, Bionpharma Inc. is voluntarily recalling (1) single Batch (2310083) of Atovaquone Oral Suspension, 750mg per mL to the consumer level. The product was manufactured by CoreRx, Inc. in Clearwater, FL and distributed by Bionpharma ...

September 10, 20249:32 pm

Innovation Bakers, LLC Issues Allergy Alert on Undeclared Walnut in 7-Eleven Fudge Brownie Distributed in... Innovation Bakers, LLC of Fullerton, CA, is issuing a voluntary limited recall of one day’s production of its 3.5 oz packs of 7-Eleven Fudge Brownie (05254856392) because they may contain undeclared walnuts. People who have an allergy or severe sensitivity ...

September 6, 202410:08 pm

Eagle Produce LLC Recalls Whole Cantaloupe Because of Possible Health Risk Eagle Produce LLC Scottsdale, AZ is initiating a recall of 224 cases of whole cantaloupe because they have the potential to be contaminated with Salmonella. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, ...

September 6, 20248:35 pm

Milo’s Poultry Farms, LLC., Recalls Eggs Because of Possible Health Risk Milo’s Poultry Farms, LLC. of Bonduel, WI is recalling all “Milo’s Poultry Farms” and “Tony’s Fresh Market” branded eggs because these eggs have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections ...

September 5, 20244:34 pm

Hammond’s Candies Issues Allergy Alert on Undeclared Milk in Hammond’s Dark Chocolate Filled Mini Waffle... Hammond’s Candies of Denver, CO is recalling 4-ounce bags of Dark Chocolate Filled Mini Waffle Cones because they may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic ...

September 4, 20246:25 pm

Niitakaya USA Inc. Issues Allergy Alert on Undeclared Allergen of Fish (Bonito) in #3700 Shiso... Niitakaya USA Inc. of Montebello, CA, is recalling All Best By dates of its 5.2 ounce (147 gram) packages of #3700 Shiso Katsuo Ninniku /#3701 Miso Katsuo Ninniku because they may contain undeclared Allergen of Fish (Bonito). People who have ...

August 29, 20249:42 pm

M&P Food Production Issues Allergy Alert on Undeclared Wheat and Milk in Vareniki, Pirozhki, and... M&P Food Production Ltd. of Brooklyn, NY is recalling multiple flavors of blintzes, pirozhki, and vareniki, because it may contain undeclared wheat, milk, and/or sesame. People who have an allergy or severe sensitivity to wheat, milk, and/or sesame run the ...

August 29, 20244:00 am

Asli Fine Foods . Recalls Asli Cinnamon Powder 7 oz Because of Possible Health Risk Asli Fine Foods of Woodridge, IL is recalling Asli Cinnamon Powder 7 oz, because it has the potential to be contaminated with Lead, Short term exposures to very low levels of lead may not elicit any symptoms. It is possible ...

August 26, 20243:19 pm

Sunco & Frenchie Issues an Allergy Alert on Undeclared Sulfites in Golden Raisins Sunco & Frenchie LLC of Pine Brook, New Jersey is recalling its 10oz Terrafina Golden Raisins because they may contain undeclared sulfites. People who have an allergy or severe sensitivity to sulfites run the risk ...

August 23, 20249:13 pm

Sri Lakshmi Narasimhar Overseas LLC Issues an Allergy Alert on Undeclared Milk and Sesame Seeds... Sri Lakshmi Narasimhar Overseas LLC of Edison, New Jersey is recalling the following products because Bliss Tree Butter Snacks may contain undeclared milk and/or sesame seeds. The presence of undeclared milk and/or sesame were discovered during the FDA review of ...

August 23, 20248:05 pm

Gutierrez Distributor Expands Recall of Ground Cinnamon Because of Possible Health Risk Gutierrez Distributor of Passaic, NJ is recalling El Servidor Corp and Gutierrez brand ground cinnamon because it has the potential to be contaminated with elevated levels of lead. Short term exposures to very low levels of lead may not elicit ...

August 23, 20241:47 pm

Sierra Stain Recalls Tattoo Pigments Because of Possible Health Risk Sierra Stain LLC of Carson City, Nevada is recalling 3 water-based tattoo pigments, because they are contaminated with high concentrations of microorganisms which present a health concern to consumers. Commonly reported symptoms of tattoo ink associated infections include the appearance ...

August 21, 20246:14 pm

Unilever U.S. Issues Allergy Alert on Undeclared Milk in Popsicle Jolly Rancher SingleServe Frozen Confection... Unilever in the United States is recalling approximately 137,000 cases of Popsicle Jolly Rancher Frozen Confection Pop products (single serve offerings) because the products may contain milk, which is not listed as an ingredient on the label. Persons who have ...

August 21, 20242:11 pm

Authentik Fudge Recalls Fudge with Nuts Because of Potential Mold Growth Authentik Fudge of Sainte-Julie, Quebec, Canada, is recalling 840 units of Chocolate Fudge with Nuts branded MONTREAL FUDGE, due to potential mold growth contamination.

August 20, 20246:31 pm

Veata LLC Issues Voluntary Nationwide Recall of Endurance Pro Capsules Due to the Potential Presence... Sacramento CA, Veata LLC is voluntarily recalling lot 230811, Exp 8/11/25 of Endurance Pro Energy Boost capsules, packaged in 10-count blisters ina cardboard carton to the consumer level. Veata LLC was notified by Amazon that the products were found to ...

August 19, 20249:39 pm

Smiths Medical Issues Urgent Medical Device Notification Informing Customers of a Potential Issue with Certain... Smiths Medical issued an Urgent Medical Device Notification on May 29, 2024, to notify affected customers of a potential issue with certain Bivona® Tracheostomy Tubes

August 19, 20247:27 pm

Gutierrez Distributor Recalls El Servidor Corp Ground Cinnamon Because of Possible Health Risk Gutierrez Distributor of Passaic, NJ is recalling El Servidor Corp brand ground cinnamon because it has the potential to be contaminated with elevated levels of lead. Short term exposures to very low levels of lead may not elicit any symptoms. ...

August 16, 202410:10 pm

Flagstone Foods, LLC. Allergy Alert on Undeclared Peanuts, Almonds and Pecan in Emerald Kettle Glazed... Flagstone Foods, LLC., manufacturer of Emerald Nuts, is issuing a voluntary recall of 6.5oz Emerald Kettle Glazed Walnut lot 2EE06284 because packages contain undeclared Peanuts, Almonds and Pecans. People who have an allergy or severe sensitivity to Peanuts, Almonds, ...

August 13, 20249:44 pm

El Chilar HF, LLC. Expands Recall of El Chilar Ground Cinnamon Due to Elevated Levels... El Chilar HF, LLC on 03/06/2024 issued a recall of Lots # D-300 EX1024 and F272 EX1026, contained in 127 boxes (12 bags/box) of El Chilar “Cinnamon Ground” (1.25 oz bag), because it may contain traces of lead. Further investigation ...

August 13, 20241:59 am

Tandem Diabetes Care Provides Update on March 2024 Nationwide Recall of t:connect Mobile App for... Tandem Diabetes Care, Inc. (Nasdaq: TNDM) today provided an update on the March 2024 recall of its Apple iOS t:connect mobile app in the United States relating to an issue that can cause rapid depletion of a user’s t:slim X2 ...

February 6, 20246:22 pm

FDA adds Boxed Warning for increased risk of severe hypocalcemia in patients with advanced chronic... Listen to FDA Drug Safety Podcast titled, FDA adds Boxed Warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease taking osteoporosis medicine Prolia (denosumab).

January 26, 20242:32 pm

Update on FDA’s ongoing evaluation of reports of suicidal thoughts or actions in patients taking... Listen to FDA Drug Safety Podcast, FDA's preliminary evaluation has not found evidence that use of GLP-1 RAs causes suicidal thoughts/actions.

December 8, 20232:07 pm

FDA warns of rare but serious drug reaction to the antiseizure medicines levetiracetam (Keppra, Keppra... Listen to an audio podcast of the November 28, 2023, FDA Drug Safety Communication, FDA warns of rare but serious drug reaction to the antiseizure medicines levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan).

May 31, 20231:57 pm

FDA updating warnings to improve safe use of prescription stimulants used to treat ADHD and... Listen to an audio podcast of the May 11, 2023, FDA Drug Safety Communication on warnings to improve safe use of prescription stimulants used to treat ADHD and other conditions

May 10, 202310:43 am

FDA updates prescribing information for all opioid pain medicines to provide additional guidance for safe... Listen to an audio podcast of the April 13, 2023, FDA Drug Safety Communication, FDA updates prescribing information for all opioid pain medicines to provide additional guidance for safe use.

December 16, 20229:07 pm

FDA investigating risk of severe hypocalcemia in patients on dialysis receiving osteoporosis medicine Prolia (denosumab) FDA investigating risk of severe hypocalcemia in patients on dialysis receiving osteoporosis medicine Prolia (denosumab)

July 27, 20223:18 pm

FDA warns about possible increased risk of death and serious side effects with cancer drug... Listen to an audio podcast of the June 30, 2022, FDA Drug Safety Communication. Results from a clinical trial show a possible increased risk of death with Copiktra (active ingredient duvelisib) compared to another medicine to treat leukemia and lymphoma. ...

July 7, 20224:35 pm

FDA withdrew its approval for the cancer medicine Ukoniq (umbralisib) due to safety concerns Listen to an audio podcast of the 6/1/22 for Ukoniq . FDA withdrew its approval for the cancer medicine Ukoniq (active ingredient umbralisib) due to safety concerns. Ukoniq was approved to treat two specific types of lymphoma: marginal zone ...

April 13, 20224:17 pm

FDA recommends thyroid monitoring in babies and young children who receive injections of iodine-containing contrast... Listen to an audio podcast of the March 30, 2022 FDA Drug Safety Communication Iodinated Contrast Media

February 9, 20227:08 pm

FDA investigating possible increased risk of death with lymphoma medicine Ukoniq (umbralisib) Listen to an audio podcast of the February 3, 2022, FDA Drug Safety Communication, FDA is investigating a possible increased risk of death with the cancer medicine Ukoniq (umbralisib). We are re-evaluating this risk against the benefits of Ukoniq for ...