fda regulated Recalls

689 recalls tagged with “fda regulated”.

Health & Personal Care
HIGH
FDA DRUG

Pfizer Recalling Levoxyl Due to Subpotent Drug Hazard

Pfizer Inc. recalled 29,004 bottles of Levoxyl on July 29, 2025, due to subpotency. The recall affects levothyroxine sodium tablets, 50 mcg, Rx only, distributed in the U.S. Consumers should stop using the product immediately.

Levoxyl
Subpotent drug
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Food & Beverages
HIGH
FDA FOOD

Gelson's Hummus Recalled Over Missing Refrigeration Instructions

Gelson's recalled 7,861 units of its Low Sodium No Cholesterol Classic Hummus on July 25, 2025. The product labels fail to include essential storage instructions to keep refrigerated. Consumers should not consume the product and seek a refund.

Gelsons
Gelson branded
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Health & Personal Care
HIGH
FDA DRUG

Duloxetine Capsules Recalled Due to High N-nitroso Impurity

Towa Pharmaceutical Europe recalled 1,856 bottles of Duloxetine delayed-release capsules on July 25, 2025. The recall follows the discovery of N-nitroso-duloxetine impurity exceeding FDA limits. Consumers should stop using the product immediately and seek guidance.

DULOXETINE
CGMP Deviations:
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Health & Personal Care
HIGH
FDA DEVICE

Beckman Coulter MicroScan Neg MIC 56 Panels Recalled for Contamination Risk (2026)

Beckman Coulter recalled 685 boxes of MicroScan Neg MIC 56 panels distributed nationwide to U.S. healthcare facilities after contamination was reported in wells. Contamination could lead to unreliable antimicrobial susceptibility and organism-identification results. Health care providers should stop using the panels and follow Beckman Coulter recall instructions immediately.

Beckman Coulter
Due to
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Health & Personal Care
HIGH
FDA DEVICE

Summa Therapeutics Recalls 22 Finesse BTK Multicath Angioplasty Balloons Over Burst Specifications (

Summa Therapeutics recalled 22 units of the Finesse BTK Multicath Injectable Angioplasty Balloon Catheter sold to healthcare facilities in New Jersey and Florida. The balloon may not meet burst specifications, raising risk during angioplasty. Healthcare providers must stop using the device immediately and follow recall instructions from Summa Therapeutics.

Finesse BTK Multicath
Potential for
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Health & Personal Care
HIGH
FDA DRUG

DermaKleen Antiseptic Lotion Soap Recalled for Microbial Contamination

DermaRite Industries LLC recalled 11,321 bags of DermaKleen antiseptic lotion soap on July 17, 2025. The product, contaminated with Burkholderia cepacia, poses a serious health risk. Consumers should stop using the product immediately and contact health providers for guidance.

DERMAKLEEN
Microbial Contamination
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Health & Personal Care
HIGH
FDA DRUG

DermaRite Recalls KleenFoam Soap Over Microbial Contamination

DermaRite Industries recalled 6,973 cartridges of KleenFoam Antimicrobial Foam Soap on July 17, 2025. The product contains a harmful bacterial contamination, Burkholderia cepacia. Consumers should stop using the soap immediately and seek guidance from healthcare providers.

KLEENFOAM
Microbial Contamination
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Health & Personal Care
HIGH
FDA DRUG

Boothwyn Pharmacy Recalls Semaglutide Injection for Subpotency

Boothwyn Pharmacy recalled 642 vials of Semaglutide injection on July 9, 2025. The recall follows the discovery that the drug is subpotent. Consumers should stop using the product immediately and seek guidance from healthcare providers.

Boothwyn Pharmacy
Subpotent Drug
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Health & Personal Care
HIGH
FDA DRUG

Walmart Recalls ReliOn Alcohol Swabs for Subpotency Risk

Walmart recalled 3.46 million ReliOn Sterile Alcohol Swabs on July 7, 2025. The swabs contain isopropyl alcohol levels below the labeled concentration. Consumers should stop using the product immediately.

Walmart
Subpotent Drug-
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Food & Beverages
HIGH
FDA FOOD

Evergreen Orchard Farm Grape Juice Recalled Due to Safety Risks

Evergreen Orchard Farm recalled 78 cases of grape juice on July 3, 2025, due to a lack of pasteurization and sanitation records. The recall affects products distributed in Pennsylvania, New Jersey, and New York. Consumers should not consume the product and seek refunds.

Evergreen Orchard Farm
Lack of
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Food & Beverages
HIGH
FDA FOOD

CHETAK NEW YORK Recalls Sprouted Mat Due to Salmonella Risk

CHETAK NEW YORK recalled 5,232 packets of Deep Sprouted Mat on June 28, 2025. The product tested positive for Salmonella, a serious health risk. Consumers in CA, NJ, IL, FL, and TX should not consume the product and seek refunds.

CHETAK NEW YORK
Product tested
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Food & Beverages
HIGH
FDA FOOD

Black Girl Vitamins B12 Supplement Recalled for Undeclared Peanuts

Black Girl Vitamins recalled 9,657 bottles of its B12 dietary supplement on June 13, 2025. The product contains undeclared peanuts, which poses a serious risk to individuals with peanut allergies. Consumers should stop using the product immediately and seek a refund.

Vitalabs
Undeclared Peanuts.
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Health & Personal Care
HIGH
FDA DRUG

Immunocore Recalls KIMMTRAK Injection Due to Subpotency

Immunocore Limited recalled 7,572 vials of KIMMTRAK injection on June 10, 2025. The affected lots may not provide the intended therapeutic effect. Consumers and healthcare providers should stop using the product immediately.

IMMUNOCORE
Subpotent Drug
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Health & Personal Care
HIGH
FDA DEVICE

SEDECAL Recalls Mobile X-ray System Over Cleaning Safety Hazard

SEDECAL SA recalled one unit of its mobile X-ray system on June 10, 2025. The system is not water-resistant and poses a high hazard risk due to improper cleaning. Users must stop using the device immediately and follow the recall instructions.

SEDECAL SA
Sedecal sent
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Health & Personal Care
HIGH
FDA DEVICE

SEDECAL Recalls Mobile X-ray System Due to Water Resistance Issue

SEDECAL SA recalled 268 units of the Model Number 40KWFXPLUS Mobile X-ray system on June 10, 2025. The recall addresses concerns over improper cleaning and water resistance. Healthcare providers must stop using the device immediately and follow the manufacturer’s instructions.

SEDECAL SA
Sedecal sent
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Health & Personal Care
HIGH
FDA DEVICE

SEDECAL Recalls Mobile X-ray System Due to Cleaning Hazard

SEDECAL SA recalled six units of its Mobile X-ray system on June 10, 2025, due to improper cleaning risks. The equipment is not water-resistant, posing a potential hazard if not maintained according to the manual. Users must stop using the device immediately and follow recall instructions.

SEDECAL SA
Sedecal sent
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