fda regulated Recalls

689 recalls tagged with “fda regulated”.

Health & Personal Care
HIGH
FDA DRUG

Apotex Recalls Ophthalmic Solution Over Sterility Concerns

Apotex Inc. recalled 151,034 bottles of Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution on September 5, 2025. The recall stems from a lack of assurance of sterility due to improper bottle sealing. Consumers should stop using the product immediately and contact their healthcare provider or Apotex Corp.

BRIMONIDINE TARTRATE/TIMOLOL MALEATE OPHTHALMIC SOLUTION
Lack of
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Health & Personal Care
HIGH
FDA DEVICE

Philips Ultrasound X3-1 Transducer Recalled for Labeling Clarification in 2026 (17 Units)

Philips Ultrasound recalled 17 X3-1 ultrasound transducers nationwide in the United States. The recall is to provide clarification and labeling to define the useful life of transducers in the field. Healthcare providers and patients should stop using the affected devices immediately and await further manufacturer instructions.

Philips Ultrasound
To provide
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Health & Personal Care
HIGH
FDA DEVICE

Philips Ultrasound Recalled 11 Mini Multi TEE Transducers Over Useful-Life Labeling (2025)

Philips Ultrasound recalled 11 Mini Multi TEE ultrasound transducers distributed nationwide in the United States after a labeling clarification related to useful life. The recall centers on providing clarification and labeling to define the useful life of transducers in the field. Healthcare providers should stop using the device and follow recall instructions from Philips Ultrasound, Inc or their

Philips Ultrasound
To provide
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Health & Personal Care
HIGH
FDA DEVICE

Philips X7-2 Ultrasound Transducer Recall for 5 Units Nationwide (2026)

Philips Ultrasound recalled 5 X7-2 ultrasound transducers distributed nationwide to healthcare providers. The recall is to provide clarification and labeling to define the useful life of ultrasound transducers in the field. Healthcare facilities should stop using the recalled devices and follow Philips Ultrasound, Inc instructions or contact their provider for guidance.

Philips Ultrasound
To provide
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Health & Personal Care
LOW
FDA DEVICE

Philips 3D6-2 Ultrasound Transducer Recalled for Labeling Clarification (17 Units, 2025)

Philips recalled 17 units of the 3D6-2 Ultrasound Transducer distributed nationwide to healthcare facilities in the United States. The recall seeks to clarify labeling defining the transducer’s useful life. Clinicians and facilities should stop using the device immediately and follow Philips recall instructions.

Philips Ultrasound
To provide
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Food & Beverages
HIGH
FDA FOOD

Good and Gather Burrito Bowl Blend Recalled for Undeclared Shrimp

Good and Gather recalled 57,240 bags of Southwest-Style Burrito Bowl Blend on September 4, 2025. The product may contain undeclared shrimp, posing a serious risk to those with shellfish allergies. Consumers should not consume the product and contact ONE FROZEN for refunds or replacements.

ONE FROZEN
Product may
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Food & Beverages
HIGH
FDA FOOD

Organicare Nature's Science Recalls FemiClear Supplement Over E. Coli Risk

Organicare Nature's Science recalled 15,075 bottles of FemiClear Daily Bladder Strength Dietary Supplement on September 4, 2025. The recall stems from microbial contamination with E. coli O7:K1 and E. coli 1303. Consumers should not consume the product and seek refunds immediately.

Organicare Nature's Science
Microbial contamination
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Food & Beverages
HIGH
FDA FOOD

Sadecki Bartnik Recalls Bee Pollen Over Chemical Hazard

Sadecki Bartnik recalled 336 jars of bee pollen on September 4, 2025, due to detectable pyrrolizidine alkaloids. These compounds pose health risks if consumed. Consumers should stop using the product immediately and seek a refund.

Gospodarstwo Pasieczne Sadecki Bartnik
detectable pyrrolizidine
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Health & Personal Care
HIGH
FDA DEVICE

American Contract Systems Recalls Radiology Packs Over Sterilization Issues

American Contract Systems recalled 32,433 radiology packs on September 4, 2025, due to improper sterilization. The products were re-gassed after a nonconformance in the initial Ethylene Oxide gas injection process. Their safety and effectiveness remain unverified after multiple sterilization cycles.

American Contract Systems
Identified products
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Food & Beverages
HIGH
FDA FOOD

Wegmans Recalls Fruit Cocktail Due to Lead Contamination Risk

Wegmans Food Markets recalled 609 cases of Fruit Cocktail on September 4, 2025, due to potential lead contamination. The affected product includes diced peaches and pears, distributed across multiple states. Consumers should not consume the recalled product and seek a refund or replacement.

Pacific Coast Producers
Potential contamination
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Health & Personal Care
HIGH
FDA DRUG

Zydus Lifesciences Recalls Chlorpromazine Tablets Due to Hazard

Zydus Lifesciences recalled Chlorpromazine Hydrochloride Tablets on September 3, 2025. The tablets contain N-Nitroso Desmethyl Chlorpromazine above safe intake levels. Consumers must stop using the product immediately and consult healthcare providers.

Zydus Lifesciences
CGMP Deviations:
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Health & Personal Care
HIGH
FDA DRUG

Zydus Lifesciences Recalls Chlorpromazine Tablets Over Contaminant Hazard

Zydus Lifesciences recalled Chlorpromazine Hydrochloride Tablets on September 3, 2025. The recall affects tablets with NDC 16714-051-01 due to N-Nitroso Desmethyl Chlorpromazine exceeding acceptable limits. Consumers should stop using the product immediately and consult healthcare providers.

Zydus Lifesciences
CGMP Deviations:
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Health & Personal Care
HIGH
FDA DRUG

Zydus Lifesciences Recalls Chlorpromazine Tablets Due to Contamination

Zydus Lifesciences Ltd. recalled Chlorpromazine Hydrochloride Tablets on September 3, 2025. The recall affects tablets containing N-Nitroso Desmethyl Chlorpromazine above safe limits. Consumers should stop using the product immediately and consult healthcare providers.

Zydus Lifesciences
CGMP Deviations:
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Health & Personal Care
HIGH
FDA DRUG

Zydus Lifesciences Recalls Chlorpromazine Tablets Over Chemical Hazard

Zydus Lifesciences Ltd. recalled Chlorpromazine Hydrochloride Tablets on September 3, 2025. The recall affects products with NDC 16714-050-01 due to high levels of a chemical impurity. Consumers should stop using the tablets immediately and contact healthcare providers.

Zydus Lifesciences
CGMP Deviations:
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Health & Personal Care
HIGH
FDA DRUG

Zydus Pharmaceuticals Recalls Chlorpromazine Tablets Over Hazardous Chemical

Zydus Pharmaceuticals recalled Chlorpromazine Hydrochloride tablets on September 3, 2025. The recall affects tablets manufactured in India with high levels of a hazardous chemical. Consumers must stop using the product immediately and contact their healthcare provider.

Zydus Pharmaceuticals
CGMP Deviations:
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Health & Personal Care
HIGH
FDA DRUG

Glenmark Pharmaceuticals Recalls Viorele Tablets Over Impurity Issues

Glenmark Pharmaceuticals recalled 26,928 packs of Viorele oral contraceptives on September 3, 2025. The recall follows the discovery of impurity issues in the product. Consumers should stop using the affected tablets immediately and contact healthcare providers for guidance.

Viorele
Failed Impurities/Degradation
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Health & Personal Care
HIGH
FDA DEVICE

Inpeco S.A. Recalls FlexLab X System Over Erroneous Test Results

Inpeco S.A. recalled one unit of the FlexLab X (FXX) System on September 3, 2025. The recall affects the Sample Integrity Module, which has not been FDA evaluated for safety. This may cause erroneous results or delays in patient testing.

Inpeco S.A.
The FlexLab
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