cpsc regulated Recalls

2,056 recalls tagged with “cpsc regulated”.

Health & Personal Care
HIGH
FDA DRUG

Lannett NIACIN ER 1,000 mg Recall Affects 46,848 Bottles Nationwide (2025)

Lannett Company, Inc. recalled 46,848 bottles of NIACIN Extended-release Tablets, 1,000 mg, Rx Only, distributed nationwide. The product failed dissolution specifications. Patients and healthcare providers should stop using it immediately and await recall instructions.

Lannett
Failed Dissolution
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Health & Personal Care
HIGH
FDA DRUG

Ultra Umbrella Sunscreen by CA BOTANA Recalled for CGMP Deviations in 874 Tubes (HIGH Hazard)

CA BOTANA International recalled 874 tubes of Sea Enzyme Ultra Umbrella Sunscreen SPF 30. The recall, active as of Dec 3, 2025, covers tubes with lot D53950 and expiration 05/31/2027 distributed in CA, CO, FL, PR, and WA. The agency cites CGMP deviations as the hazard. Consumers should stop using this product immediately and contact CA BOTANA for guidance or consult a healthcare provider.

CA BOTANA
CGMP Deviations
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Health & Personal Care
HIGH
FDA DRUG

Weh-Weh Pain Reliever Gel Recalled for CGMP Deviations, 810 Tubes Affected (2025)

CA BOTANA International recalled 810 tubes of Doctor D. Schwab Weh-Weh Natural Pain Relief Gel due to CGMP deviations. The recall covers tubes distributed to California, Colorado, Florida, Puerto Rico and Washington. Consumers should stop using the product immediately and contact CA BOTANA for guidance.

WEH-WEH PAIN RELIEVER GEL
CGMP Deviations
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Health & Personal Care
HIGH
FDA DRUG

Sugared+Bronzed Tinted Mineral Sunscreen SPF 50 Recalled for CGMP Deviations (Class II)

Sugared+Bronzed recalled 2,090 tubes of tinted mineral sunscreen distributed to California, Colorado, Florida, Puerto Rico and Washington after CGMP deviations were found. The recall, initiated by CA BOTANA International, is active as of Dec 3, 2025. Consumers should stop using the product immediately and contact the distributor for guidance.

Sugared+Bronzed
CGMP Deviations
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Health & Personal Care
HIGH
FDA DRUG

CA Botana Sunscreen Flawless Skin Fluid Tint SPF 50 Recall 2025

CA Botana International recalls Sunscreen Flawless Skin Fluid Tint SPF 50 after CGMP deviations. The recall covers 1,401 tubes distributed to California, Colorado, Florida, Puerto Rico and Washington. Stop using the product and contact CA Botana for guidance.

CA Botana International
CGMP Deviations
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Health & Personal Care
HIGH
FDA DRUG

Elixir by Coco March Tinted Mineral Sunscreen SPF 50 Recalled for CGMP Deviations

A recall is active for Elixir by Coco March Tinted Mineral Sunscreen SPF 50 amid CGMP deviations. The product is distributed by CA Botana International, Inc. The recall cites CGMP deviations as the hazard and class II designation. Consumers should stop using the product and follow guidance from healthcare providers.

SUNSCREEN
CGMP Deviations
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Health & Personal Care
HIGH
FDA DRUG

CA Botana Doctor D. Schwab Shimmery Sun Lotion Sunscreen Recall for CGMP Deviations (2025)

CA Botana International recalled 805 tubes of Doctor D. Schwab Shimmery Sun Lotion Sunscreen SPF 30 after CGMP deviations were identified. The recall covers tubes sold in California, Colorado, Florida, Puerto Rico, and Washington. Consumers should stop using the product immediately and contact the company for guidance.

Doctor D. Schwab
CGMP Deviations
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Health & Personal Care
HIGH
FDA DEVICE

Thoratec Recalls CentriMag Blood Pump Over Serious Hazard

Thoratec recalled 8,399 CentriMag Blood Pumps on October 10, 2025, due to a significant malfunction risk. The blood pump may not securely lock into the motor, potentially leading to serious health complications. The recall affects models distributed worldwide, including across the United States and several countries.

Thoratec
Acute circulatory
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Health & Personal Care
HIGH
FDA DRUG

Gabapentin 100 mg Capsules Recalled by Major Pharmaceuticals in 2025, 100-Count Pack

Major Pharmaceuticals recalled Gabapentin capsules, 100 mg, 100-count, distributed nationwide in the United States. The recall stems from an out-of-spec highest unknown impurity found during stability testing. Healthcare providers and patients should stop using the product and contact The Harvard Drug Group LLC for guidance.

Gabapentin
Failed Impurities/Degradation
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Health & Personal Care
HIGH
FDA DRUG

Major Pharmaceuticals Gabapentin 100 mg 10-Capsule Recall Nationwide 2025

Major Pharmaceuticals recalled Gabapentin Capsules, USP, 100 mg, 10 capsules per blister pack, distributed nationwide in the United States. The recall cites failed impurities and degradation specifications from routine stability testing, specifically an out-of-spec Highest Unknown Impurity. Consumers and healthcare providers should stop using this product immediately and contact The Harvard Drug集团

Gabapentin
Failed Impurities/Degradation
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Health & Personal Care
HIGH
FDA DRUG

555 Doctor D. Schwab Controlling Balm Tubes Recalled Over CGMP Violations

Doctor D. Schwab recalled 555 tubes of Controlling Balm with Tea Tree Oil after identifying CGMP deviations. The product may not meet quality standards, posing a safety risk. Consumers should stop using the balm immediately and contact CA BOTANA for guidance.

Doctor D. Schwab
CGMP Deviations
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Recalled Scripto® Premium Torch
HIGH
CPSC

Calico Brands Recalls Scripto Premium Torch for Fire and Burn Hazard (2025)

Calico Brands recalls the Scripto Premium Torch due to fire and burn hazards. The recall covers torches with a four-position adjustable metal nozzle and a hands-free operation lock. Consumers should stop using the recalled torches and return them to the retailer for a full refund or store credit.

Calico Brands
The recalled
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Health & Personal Care
HIGH
FDA DRUG

STAQ Pharma Hydromorphone HCl PF 10mg/50mL IV Injection Recall for Labeling Errors (2025)

STAQ Pharma’s Hydromorphone HCl PF 10mg/50mL IV injection recall affects nationwide distribution in the United States. The recall cites labeling errors involving incorrect or missing lot and expiration dates. Healthcare providers and patients must stop using the product and follow guidance from STAQ Pharma or their clinician.

STAQ Pharma
Labeling: Incorrect
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Recalled Bellabu Bear Children's Robe - Batman
HIGH
CPSC

Bellabu Bear Recalls Bamboo Sherpa Children's Robes for Burn Hazard (2025)

Bellabu Bear recalls its bamboo sherpa children's robes sold at Saks Fifth Avenue stores and online retailers from January 2024 through July 2025 for about $60. The robes do not meet mandatory flammability standards for children's sleepwear and pose a burn risk. Stop using the recalled robes and contact Bellabu Bear for a full refund or store credit.

Bellabu Bear
The recalled
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Recalled ESR HaloLock Kickstand Wireless Power Bank Model 2G505
HIGH
CPSC

ESR HaloLock Wireless Power Banks Recalled in Expansion to Include 2G505 Model for Fire and Burn Haz

ESR HaloLock wireless power banks were recalled in an expansion that now includes model 2G505. The recall covers models 2G520, 2G505B and 2G512B previously recalled and adds 2G505. The recall is distributed by Waymeet. The lithium-ion batteries can overheat and ignite. Consumers should stop using recalled power banks and seek a full refund from Waymeet.

ESR HaloLock
The lithium-ion
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Health & Personal Care
HIGH
FDA DEVICE

Pivotal Health Solutions Recalls 34 Quantum Q400 Heated Massage Tables for Overheating Risk (2025)

Pivotal Health Solutions is recalling 34 Quantum Q400 intersegmental heated massage tables sold nationwide in the United States, Canada and Japan. The recall cites heat-function components that can be damaged over time when pressed, risking overheating, smoldering and melting of the vinyl cushion. Clinicians and patients should stop using the device immediately and await manufacturer instructions.

Pivotal Health Solutions
The heat
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