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US Food and Drug Administration

Norovirus Outbreak Prompts Recall Of Oysters Sold In NY Norovirus Outbreak Prompts Recall Of Oysters Sold In NY
Norovirus Outbreak Prompts Recall Of Oysters Sold In NY New York, New Jersey, Pennsylvania and Washington DC residents are being urged to avoid consuming certain oysters after a recall linked to a norovirus outbreak, federal officials announced.  The contaminated oysters were sold under the brands Fanny Bay, Buckley Bay, and Royal Miyagi and harvested between Dec. 1 and Dec. 9, 2024, from British Columbia (BC), Canada, according to the U.S. Food and Drug Administration (FDA). The oysters, distributed by S&M Shellfish Co. of San Francisco, were shipped to retailers and restaurants across several states, including New Jersey, New York, Pe…
Recall Issued For Ready-To-Eat Produce Sold In NY Stores Over Potential Listeria Contamination Recall Issued For Ready-To-Eat Produce Sold In NY Stores Over Potential Listeria Contamination
Recall Issued For Ready-To-Eat Produce Sold In NY Stores Over Potential Listeria Contamination Ready-to-eat fruit and vegetable products sold in the parts of the Northeast are being recalled. Connecticut-based Gracie’s Kitchens Inc., located in New Haven, has issued the recall due to potential contamination with Listeria, a bacteria that can cause serious health risks, according to the US Food and Drug Administration (FDA). The recall involves products manufactured between Monday, Nov. 4 and Wednesday, Nov. 13, and sold under the Gracie’s Kitchens, King Kullen, and Wild By Nature brands.   The products were distributed to grocery stores in New York and Connecticut. Items …
Frozen Waffle Listeria Recall Expands To 14+ Grocery Store Brands Frozen Waffle Listeria Recall Expands To 14+ Grocery Store Brands
Frozen Waffle Listeria Recall Expands To 14+ Grocery Store Brands A massive voluntary recall has been issued for frozen waffles sold by over 14 different grocery store chains nationwide due to the potential contamination with Listeria monocytogenes, TreeHouse Foods, Inc. announced on Friday, Oct. 18. Over 500 varieties of frozen waffles manufactured by TreeHouse Foods and sold with the branding of major retailers such as Walmart's Great Value and Target's Good & Gather have been recalled because of possible Listeria.  As stated in the release: "Listeria monocytogenes is an organism that can cause serious and sometimes fatal infections …
Walmart Issues Massive Recall For Juice Product Sold In 23 States, Including NY Walmart Issues Massive Recall For Juice Product Sold In 23 States, Including NY
Walmart Issues Massive Recall For Juice Product Sold In 23 States, Including NY Apple juice sold at Walmart has been recalled due to high arsenic levels. The US Food and Drug Administration says 9,535 cases of the company's  Great Value brand 100 percent apple juice were sold in six-packs of 8-ounce plastic bottles bearing this expiration date: Best if Used by DEC2824 CT89-6, and a UPC code of 0-78742-29655-5. According to the FDA, the product contains inorganic arsenic above the action level set in industry guidance (13.2 parts per billion). They were sold in 23 states: New York, New Jersey, Connecticut, Massachusetts, Pennsylvania, Virginia,…
FDA Investigates Microdosed Chocolate After 48 People Fall Ill, Including New Yorker FDA Investigates Microdosed Chocolate After 48 People Fall Ill, Including New Yorker
FDA Investigates Microdosed Chocolate After 48 People Fall Ill, Including New Yorker Health officials are investigating a previously-recalled brand of micro-dosed gummies, chocolates, and cones after dozens have been hospitalized and one potentially associated death has been recorded. On Tuesday, July 2, the US Food and Drug Administration (FDA) gave an update on the investigation of Diamond Shruumz brand microdose products, reporting that since the initial recall, 48 people have fallen ill from 24 states, including New York. The administration first announced the recall on June 7. The products (which come in chocolate, cones, and gummy form) were later found to contain m…
Supplements Sold Nationwide Being Recalled Due To Presence Of 'Gas Station Heroin' In Products Supplements Sold Nationwide Being Recalled Due To Presence Of 'Gas Station Heroin' In Products
Supplements Sold Nationwide Being Recalled Due To Presence Of 'Gas Station Heroin' In Products Federal Health officials are cautioning consumers to avoid certain products that may contain an ingredient known as "gas station heroin."  Neptune Resources LLC announced a voluntary recall of all lots of "Neptune's Fix Elixir," "Neptune's Fix Extra Strength Elixir," and Neptune's Fix Tablets due to the possible presence of tianeptine, the US Food and Drug Administration (FDA) announced. Tianeptine, which has been called "gas station heroin" by some, is not FDA-approved for any medical use, and its presence in the products prompted the nationwide recall. "The presence of tianepti…
Contamination Concerns Prompt Nationwide Robitussin Cough Syrup Recall Contamination Concerns Prompt Nationwide Robitussin Cough Syrup Recall
Contamination Concerns Prompt Nationwide Robitussin Cough Syrup Recall Two types of Robitussin cough syrup products sold nationwide are being recalled due to potential microbial contamination, federal authorities announced. This week, New Jersey-based Haleon announced a recall of several lots of Robitussin Honey CF Max Day Adult and Robitussin Honey CF Max Nighttime Adult that could be contaminated, according to the US Food and Drug Administration (FDA). Recalled items include:  Four- and eight-ounce Robitussin Honey CF Max Day Adult with these lot numbers/expiration dates:  T18010 with an expiration date of Oct. 31, 2025; T08730 with an…
NY Companies Sold Adulterated, Misbranded Dietary Supplements, Feds Say NY Companies Sold Adulterated, Misbranded Dietary Supplements, Feds Say
NY Companies Sold Adulterated, Misbranded Dietary Supplements, Feds Say Federal regulators stepped in when a New York business owner allegedly sold dietary supplements that weren’t all they were cracked up to be. Mohammed Islam agreed to settle a civil complaint from the US Food and Drug Administration (FDA) in Brooklyn federal court on Monday, Dec. 18. The complaint, filed in October 2023, alleged that Islam’s Long Island-based companies – Total Body Nutrition, TBN Labs, and Loud Muscle Science – violated federal law by manufacturing and distributing adulterated and misbranded dietary supplements. Specifically, an investigation found that the companies failed…
Applesauce Pouches May Have Been Intentionally Contaminated: FDA Applesauce Pouches May Have Been Intentionally Contaminated: FDA
Applesauce Pouches May Have Been Intentionally Contaminated: FDA Lead contamination from applesauce that sickened dozens of youngsters may have been an "intentional act," a US Food and Drug Administration (FDA) official said in a brand-new report. The WanaBana Apple Cinnamon Fruit Purée Pouches were distributed nationwide through online and retail stores. The products subject to the recall, along with lot codes, are: WanaBana apple cinnamon fruit puree pouches – including three packs of 2.5 oz. - with the following lot codes shown on this page from the (FDA). Schnucks-brand cinnamon-flavored applesauce pouches and variety pack, 90g pouches, were …
Massive Eye Drop Recall Expands: 3 Products Added As List Hits 29; Here's New Rundown Massive Eye Drop Recall Expands: 3 Products Added As List Hits 29; Here's New Rundown
Massive Eye Drop Recall Expands: 3 Products Added As List Hits 29; Here's New Rundown Three new products have been added to a  recall of more than two dozen over-the-counter eye drops because of the risk of eye infections that may lead to vision loss or blindness. The now 29 products are from these brands: CVS Health, Leader (Cardinal Health), Rugby (Cardinal Health), Rite Aid, Target Up&Up, and Velocity Pharma. The alert comes after FDA investigators found bacterial contamination in critical drug production areas of a manufacturing facility. The list the US Food and Drug Administration (FDA) provided late last month five Cardinal Health, Inc. p…
COVID-19: FDA Approves Updated Booster Shots Targeting New Variants COVID-19: FDA Approves Updated Booster Shots Targeting New Variants
Covid-19: FDA Approves Updated Booster Shots Targeting New Variants Health officials are one step closer to rolling out updated COVID-19 vaccines just in time for a rise in cases heading into the fall and winter months. The US Food and Drug Administration (FDA) approved new vaccines on Monday, Sept. 11, that are meant to better target currently circulating COVID-19 variants and provide better protection against hospitalization and death, the agency announced. Monday’s move affects vaccines manufactured by Moderna and Pfizer. The updated mRNA vaccines are each approved for people ages 12 and older and are authorized under emergency use for children ages 6 mo…
Restaurants, Stores Warned Not To Sell Contaminated Oysters From This Area In Northeast Restaurants, Stores Warned Not To Sell Contaminated Oysters From This Area In Northeast
Restaurants, Stores Warned Not To Sell Contaminated Oysters From This Area In Northeast Federal officials are warning restaurants and stores across the Northeast to stop selling oysters harvested from an area in Connecticut, as they may be contaminated with pathogens that cause food poisoning.  The US Food and Drug Administration has advised consumers, restaurants, and retailers across several states in the Northeast to dispose of raw oysters harvested from the Groton Approved Area in New London County between Monday, Aug. 28 and Wednesday, Aug. 30, officials announced on Tuesday, Sept. 5.  The affected raw oysters were sent to retailers and distributors in Connectic…
COVID-19: Recall Issued For Brand Of Rapid Tests That Could Produce Inaccurate Results COVID-19: Recall Issued For Brand Of Rapid Tests That Could Produce Inaccurate Results
Covid-19: Recall Issued For Brand Of Rapid Tests That Could Produce Inaccurate Results A manufacturer has recalled more than 56,000 COVID-19 rapid tests because they could produce inaccurate results. Universal Meditech Inc. issued the recall for Skippack Medical Lab antigen tests because they were distributed without appropriate clearance or approval by the US Food and Drug Administration (FDA). The kits were made from October 2021 to December 2021 and distributed in January 2022. The following styles/models have been recalled: Name of Product: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit UDI: None Model: Cassette Products were distributed with “Sk…
COVID-19: Recall Issued For Brand Of Over-Counter Tests That Could Give False Negative Results COVID-19: Recall Issued For Brand Of Over-Counter Tests That Could Give False Negative Results
Covid-19: Recall Issued For Brand Of Over-Counter Tests That Could Give False Negative Results A new recall has been issued for a brand of COVID-19 tests due to an increased chance that the tests may give false negative results Detect, Inc. is voluntarily recalling specific lots of the Detect COVID-19 Test, an over-the-counter test used to identify SARS-CoV-2 (the virus that causes COVID-19) in self-collected nasal swabs. The recall affects 11,102 tests shipped to customers from July 26, 2022, through Aug. 26, 2022, the company said. The test was granted Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) in October, 2021. There is an increased chance t…
Common Drug Shortage Hits US Common Drug Shortage Hits US
Common Drug Shortage Hits US There's a shortage of some commonly found medications as this cold and flu season is off to the worst start in more than a decade, according to the US Food and Drug Administration (FDA). According to VOX, the reason for the shortages could be either due a lack of raw materials or a problem at the manufacturing plant. The following drugs and medications might be more difficult to find on shelves this year, according to the FDA: Albuterol Sulfate Inhalational Solution: Caused by a high-demand for the drug at the onset of the COVID-19 pandemic, VOX says. Amoxicillin (Oral Powder for Suspensi…
Recall Issued Issued For Several Shampoo Products Due To Possible Cancer-Causing Agents Recall Issued Issued For Several Shampoo Products Due To Possible Cancer-Causing Agents
Recall Issued Issued For Several Shampoo Products Due To Possible Cancer-Causing Agents Several shampoo products are being recalled due to the presence of possible cancer-causing agents.  The US Food and Drug Administration has announced the recall of select dry shampoo aerosol products produced prior to October 2021 by Dove, Nexxus, Suave, TIGI (Rockaholic and Bed Head), and TRESemmé due to "potentially elevated levels of benzene," FDA officials said.  The recall was issued by Unilever on Tuesday, Oct. 18, the company that owns the brands of the recalled products.  A complete list of recalled products is available here. Benzene is classified as a carcino…
COVID-19: New Booster Shots Targeting Omicron Variant Approved By FDA COVID-19: New Booster Shots Targeting Omicron Variant Approved By FDA
Covid-19: New Booster Shots Targeting Omicron Variant Approved By FDA It’s time to roll up your sleeve and get another COVID-19 vaccine. On Wednesday, Aug. 31, the US Food and Drug Administration (FDA) approved updated versions of COVID booster shots made by Pfizer and Moderna that target the highly contagious BA.5 Omicron subvariant. The updated vaccine boosters are designed to give people broad protection against COVID and can help protect against severe illness, hospitalization, and death, the FDA said in a statement. Pfizer’s modified booster was authorized for people ages 12 and older, while Moderna’s shot was approved for those 18 and up. People who…
NY Health Commissioner Orders All Pharmacies To Carry Overdose Medication Naloxone NY Health Commissioner Orders All Pharmacies To Carry Overdose Medication Naloxone
NY Health Commissioner Orders All Pharmacies To Carry Overdose Medication Naloxone Pharmacies in New York will soon be required to carry and dispense naloxone, the medicine used to quickly reverse the life-threatening effects of an opioid overdose. The state’s health commissioner, Dr. Mary Bassett, issued a statewide standing order for all pharmacies to carry the medication and dispense it without a prescription beginning Monday, Aug. 15. “This is as close as we can get to naloxone being 'over the counter' without action being taken by the US Food and Drug Administration,” Bassett said. Often sold under the brand name Narcan, naloxone is easily administered and can help…
COVID-19: Vaccines For Kids Under 5 Unanimously Recommended By Expert FDA Panel COVID-19: Vaccines For Kids Under 5 Unanimously Recommended By Expert FDA Panel
Covid-19: Vaccines For Kids Under 5 Unanimously Recommended By Expert FDA Panel Federal health officials are moving closer to authorizing COVID-19 vaccines for the youngest Americans. The US Food and Drug Administration (FDA) voted on Wednesday, June 15 to recommend authorizing both the Moderna and Pfizer COVID-19 vaccines for children between the ages of 6 months and 5 years old. On Wednesday, the agency’s independent panel of experts voted to recommend the vaccines - which are currently only available for Americans 5 years and older - for younger children. All 21 members of the FDA's Vaccines and Related Biological Products Advisory Committee unanimously voted to a…
National Recall Issued For Rainbox Sprinkles Products National Recall Issued For Rainbox Sprinkles Products
National Recall Issued For Rainbox Sprinkles Products A popular rainbow sprinkle product is being recalled, according to federal health officials. Illinois-based Wilton Industries initiated a voluntary recall of certain lots of Rainbow Chip Crunch Sprinkles And Rainbow Sprinkles Mix that may contain milk and could still be on store shelves, the US Food and Drug Administration (FDA) issued an alert on Monday, June 6. Rainbow Chip Crunch SprinklesFDA According to the FDA, the undeclared allergen is not declared on the product label after the issue was discovered earlier this month. Recalled items include: Rainbow Chip Crunch Sprinkles wi…
COVID-19: FDA Expands Eligibility For Pfizer Booster To Children 5 Through 11 COVID-19: FDA Expands Eligibility For Pfizer Booster To Children 5 Through 11
Covid-19: FDA Expands Eligibility For Pfizer Booster To Children 5 Through 11 Federal health officials have granted emergency use authorization for a booster dose of the Pfizer-BioNTech COVID-19 vaccine in children. On Tuesday, May 17, the US Food and Drug Administration (FDA) announced that it is expanding eligibility for boosters to include children between the ages of 5 and 11 years old. That age group will be permitted to receive their booster shot five months after completing their initial COVID-19 vaccination series, officials said. FDA Commissioner Robert Califf said that while data shows COVID-19 is less severe in children, the vaccine and boosters can help …
New York State To Provide Resources For Families Amid Baby Formula Shortage New York State To Provide Resources For Families Amid Baby Formula Shortage
New York State To Provide Resources For Families Amid Baby Formula Shortage Many New Yorkers got an unexpected alert on their cellphones as state officials seek to assist families struggling amid the nationwide baby formula shortage. On Friday, May 13, anyone who downloaded the NY State Excelsior Pass during the COVID-19 pandemic to prove their vaccination status received an alert advising that the state is prepared to provide resources to families. Original story - Parents, Retailers Deal With National Baby Formula Shortage According to New York Gov. Kathy Hochul, since the recall of certain powdered infant formula products in February, the US Food and Drug A…
COVID-19: New Recall Issued For Rapid Tests, FDA Says COVID-19: New Recall Issued For Rapid Tests, FDA Says
Covid-19: New Recall Issued For Rapid Tests, FDA Says A new recall has been issued for some COVID-19 rapid tests that are not authorized for distribution, the US Food and Drug Administration announced on Tuesday, May 10. The FDA is warning people not to use the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold). Click here for the product codes. "This test is not authorized, cleared, or approved by the FDA for distribution or use in the United States," said the FDA, noting it "is concerned about the risk of false results when using this test because SML Distribution LLC has not provided the FDA with adequate data to show the t…