fda regulated Recalls

689 recalls tagged with “fda regulated”.

Health & Personal Care
HIGH
FDA DRUG

Lannett Company Recalls Dextroamphetamine Tablets Over Foreign Tablet Risk

Lannett Company recalled 4,848 bottles of Dextroamphetamine tablets on August 19, 2025. The recall stems from the presence of a foreign tablet in some bottles. This poses a significant risk to consumers who may inadvertently take the incorrect dosage.

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate
Presence of
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Recalls Preventive Maintenance Kit Over Hazard Risk

Boston Scientific recalled one unit of the Preventive Maintenance Kit ICEFX on August 18, 2025. Certain desiccant tube subassemblies had improperly tightened end caps. This recall affects distribution in the US, Canada, France, Germany, and Italy.

Boston Scientific
Certain desiccant
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Health & Personal Care
HIGH
FDA DEVICE

Maquet Cardiovascular Recalls Heartstring III Occluder Due to Failure Risks

Maquet Cardiovascular recalled 32,867 units of the Heartstring III Proximal Seal System on August 15, 2025. Three failure modes can lead to inadequate hemostasis during procedures. Patients and healthcare providers must stop using this device immediately.

Maquet Cardiovascular
Three failure
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Food & Beverages
HIGH
FDA FOOD

Great Value, Sea Best Frozen Shrimp Recalled Over Cesium-137 Risk

Beaver Street Fisheries recalled 33,164 pounds of Great Value and Sea Best raw frozen shrimp on August 15, 2025. The product may contain Cesium-137, a radioactive substance. Consumers should not consume the affected shrimp and should seek refunds.

Beaver Street Fisheries
Product may
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Health & Personal Care
HIGH
FDA DEVICE

Maquet Cardiovascular Recalls Heartstring III Occluders Over High Hazard

Maquet Cardiovascular recalled the Heartstring III Proximal Seal System on August 15, 2025, due to three identified failure modes. These failures include issues with the seal's loading, deployment, and hemostasis. The recall affects 168 units distributed worldwide.

Maquet Cardiovascular
Three failure
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Food & Beverages
HIGH
FDA FOOD

Stanley Pearlman Enterprises Recalls Whiting Fillet Over Date Error

Stanley Pearlman Enterprises recalled 141 cases of whiting fillets on August 15, 2025. The bags contain an incorrect best by date that misrepresents the product's shelf life. The fillets are actually good until January 11, 2027.

Stanley Pearlman Enterprises
Recall initiated
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Food & Beverages
HIGH
FDA FOOD

AquaStar Cocktail Shrimp Recalled Due to Cesium-137 Contamination

AquaStar recalled 22,500 cases of its Cocktail Shrimp on August 14, 2025, due to potential contamination with Cesium-137. The shrimp was sold at Walmart stores across 25 states between July 31 and August 16, 2025. Consumers should not consume the product and seek a refund.

AquaStar
Product may
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Health & Personal Care
HIGH
FDA DEVICE

Philips CT System Recalled Due to Unexpected Descent Hazard

Philips recalled 6 CT 6000 systems on August 13, 2025. The patient support table may descend unexpectedly due to a ball screw misalignment. This recall affects devices distributed worldwide, including the U.S.

Philips North America
The patient
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Food & Beverages
HIGH
FDA FOOD

Fresh & Ready Foods Recalls Ciabatta Sandwiches Over Allergen Risk

Fresh & Ready Foods LLC recalled 233 units of Spanish Club Ciabatta sandwiches on August 13, 2025. The recall stems from undeclared allergens, specifically wheat and milk, posing a high risk to consumers. The products were available at 15 corporate locations across California.

Fresh & Ready Foods
undeclared allergen
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Food & Beverages
HIGH
FDA FOOD

Fresh & Ready Foods Recalls Salad Over Undeclared Allergens

Fresh & Ready Foods LLC recalled 233 units of Tuscan Artichoke and Mozzarella Salad on August 13, 2025. The recall stems from undeclared wheat and milk allergens in ready-to-eat sandwiches. The affected products were distributed to 15 locations in California.

Fresh & Ready Foods
undeclared allergen
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Health & Personal Care
HIGH
FDA DRUG

Sandoz Recalls Ciprofloxacin and Dexamethasone Otic Suspension Due to Temperature Abuse

Sandoz, Inc. recalled 1,680 bottles of Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension on August 13, 2025. The recall stems from temperature abuse that may compromise the product's efficacy. Consumers should stop using the product immediately and contact their healthcare provider or Sandoz for guidance.

CIPROFLOXACIN AND DEXAMETHASONE
Temperature Abuse
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Food & Beverages
HIGH
FDA FOOD

Fresh & Ready Foods Recalls Sandwiches Over Undeclared Allergens

Fresh & Ready Foods LLC recalled 233 units of Piccolo Pranzo Box sandwiches on August 13, 2025. The recall follows the discovery of undeclared allergens, specifically wheat and milk, posing a serious risk to consumers. The recalled products were distributed to 15 locations across California.

Fresh & Ready Foods
undeclared allergen
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Food & Beverages
HIGH
FDA FOOD

Wegmans Camembert Cheese Recalled Due to Listeria Risk

Wegmans Food Markets recalled 4,884 units of Medium Camembert Soft Ripened Cheese on August 12, 2025. The product may be contaminated with Listeria monocytogenes, posing a serious health risk. Consumers should not eat the cheese and should contact the company for refunds.

Wegmans Food Markets
Products may
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Food & Beverages
HIGH
FDA FOOD

Wegmans Cheese Flight Recalled Due to Listeria Contamination

Wegmans Food Markets recalled 4,884 units of its Assorted Cheese Flight on August 12, 2025. The product may be contaminated with Listeria monocytogenes, a serious foodborne pathogen. The recall affects consumers in NY, PA, MA, NJ, MD, VA, NC, DE, CT, and DC.

Wegmans Food Markets
Products may
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Food & Beverages
HIGH
FDA FOOD

Wegmans Grilling Camembert Recalled Due to Listeria Risk

Wegmans Food Markets recalled 4,884 units of Grilling Camembert on August 12, 2025, due to possible contamination with Listeria monocytogenes. The affected products are packaged in black and gold metal trays and distributed in several states including New York and Pennsylvania. Consumers should not consume this product and seek a refund or replacement.

Wegmans Food Markets
Products may
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