fda regulated Recalls

689 recalls tagged with “fda regulated”.

Food & Beverages
HIGH
FDA DRUG

Swan White Clear Alcohol Recall by Gold Star Distribution in 2026

Gold Star Distribution recalls Swan White Clear Alcohol, 50% ABV, 16 oz, 12 count, nationwide. FDA enforcement cites CGMP deviations and insanitary distribution-center conditions including rodent exposure. Stop using the product now and contact the distributor or a healthcare provider for guidance.

Swan
CGMP Deviations:
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Health & Personal Care
HIGH
FDA DRUG

Gold Star Distribution's Halls Cough Drops Recall 2026 Over Rodent-Linked CGMP Violations

Gold Star Distribution is recalling all Halls cough drops distributed nationwide. The recall covers multiple SKUs including Menthol 12-count bags and Vitamin C 20-count lozenges. The root cause cited is CGMP deviations with insanitary conditions and rodent exposure at the distribution center. Consumers should stop using these products and follow recall instructions from Gold Star Distribution.

Gold Star Distribution
CGMP Deviations:
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Health & Personal Care
HIGH
FDA DRUG

GOLD STAR DISTRIBUTION LIQUID NYQUIL Recall 12/8oz Bottles 2026

GOLD STAR DISTRIBUTION recalls LIQUID NYQUIL regular and cherry 12/8oz bottles nationwide in the United States. The recall cites CGMP deviations and insanitary conditions including rodent exposure at the distribution center. Consumers should stop using the product immediately and contact Gold Star Distribution Inc for guidance on refunds or replacements.

GOLD STAR DISTRIBUTION
CGMP Deviations:
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Health & Personal Care
HIGH
FDA DRUG

NyQuil Cold & Flu 32-Count 2-Pack Recalled for CGMP Violations (2026)

NyQuil Cold & Flu 32-count 2-pack is being recalled by Gold Star Distribution in the United States. The recall cites CGMP deviations and insanitary conditions at the distribution center, including rodent exposure. Stop using the product and contact the distributor for guidance.

NyQuil
CGMP Deviations:
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Health & Personal Care
HIGH
FDA DRUG

GOLD STAR DISTRIBUTION TUMS 12-Count Recall 2026 for Rodent-Contamination CGMP Deviations

Gold Star Distribution is recalling TUMS Assorted 12-count products sold nationwide through various retailers after CGMP deviations linked to insanitary conditions and rodent exposure at the distribution center. The recall covers three SKUs: 1194A with expiry 05/27 and 1194C with expiry 03/27, plus the Assorted 12-count variant. Consumers should stop using the product immediately and contact Gold

GOLD STAR DISTRIBUTION
CGMP Deviations:
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Health & Personal Care
HIGH
FDA DRUG

Carmex Lip Balm Recalled by Gold Star Distribution for 12-Count Jars and Tubes (2026)

Gold Star Distribution Inc. is recalling Carmex lip balm in 12-count jars and 12-count tubes distributed nationwide in the United States. The recall cites CGMP deviations and insanitary conditions at the distribution center, including rodent exposure. Consumers and healthcare providers should stop using the product immediately and contact Gold Star Distribution for guidance.

GOLD STAR DISTRIBUTION
CGMP Deviations:
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Health & Personal Care
HIGH
FDA DRUG

Gold Star Distribution Recalls Children NyQuil Cold & Flu Berry 8oz 12ct (2026 Recall)

Gold Star Distribution recalls all lots of Children NyQuil Cold & Flu Berry 8oz 12ct sold nationwide in the United States. The recall cites CGMP deviations and insanitary conditions, including rodent exposure at the distributor's center. Consumers and healthcare providers should stop using this product immediately and contact Gold Star Distribution for guidance.

Gold Star Distribution
CGMP Deviations:
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Health & Personal Care
HIGH
FDA DRUG

Gold Star Distribution Recalls Excedrin Migraine 2's 25 CT Over Rodent-Contamination Risk (2026)

Gold Star Distribution recalls Excedrin Migraine 2's, 25-count bottles distributed nationwide in the United States. CGMP deviations involve insanitary conditions including rodent exposure in the distribution center. Consumers and healthcare providers should stop using the product immediately and contact Gold Star Distribution or their healthcare provider for guidance.

Gold Star Distribution
CGMP Deviations:
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Health & Personal Care
HIGH
FDA DRUG

Colgate and Crest Toothpaste Recall 2025 by Gold Star Distribution for CGMP Deviations

Gold Star Distribution Inc. issued a nationwide recall of Colgate and Crest toothpaste on December 26, 2025 after inspectors found insanitary conditions and rodent exposure at its distribution center. The issue stems from CGMP deviations that could contaminate products. Consumers should stop using the affected toothpaste immediately and contact Gold Star Distribution for guidance.

Colgate
CGMP Deviations:
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Health & Personal Care
HIGH
FDA DRUG

Gold Star Distribution Recalls Vaseline and Other Petroleum Jelly Products for CGMP Violations (2025

Gold Star Distribution is recalling petroleum jelly products nationwide in the United States. The recall covers Vaseline brand products and other jelly variants distributed by Gold Star Distribution. The issue stems from CGMP deviations at the distribution center and insanitary conditions due to rodent exposure. Consumers should stop using the affected products immediately and contact the company.

Gold Star Distribution
CGMP Deviations:
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Health & Personal Care
HIGH
FDA DRUG

Gold Star Distribution Recalls Pepto Bismol 32-Count in 2025 Over CGMP Sanitation Violations

Gold Star Distribution is recalling Pepto Bismol 32-count distributed nationwide after CGMP deviations and unsanitary conditions at its distribution center. The recall cites rodent exposure and unsanitary distribution practices. Consumers and healthcare providers should stop using this product immediately and contact Gold Star Distribution for guidance.

Gold Star Distribution
CGMP Deviations:
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Health & Personal Care
HIGH
FDA DRUG

Gold Star Distribution Ice Gel 8oz 12-Count Recalled for CGMP Violations (2026)

Gold Star Distribution recalls 8oz Ice Gel 12-count sold nationwide after investigators found insanitary conditions at the distributor's facility. A CGMP deviation allowed rodent exposure at the distribution center. Consumers and healthcare providers should stop using this product immediately and await guidance from Gold Star Distribution.

Gold Star Distribution
CGMP Deviations:
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Health & Personal Care
HIGH
FDA DEVICE

Gold Star Distribution Recalls Feminine Hygiene Products Due to Rodent Exposure

Gold Star Distribution recalled various feminine hygiene products on December 26, 2025. The recall affects brands including KOTEX and ALWAYS due to potential rodent contamination in their distribution center. Consumers should stop using these products immediately and follow manufacturer instructions for return.

GOLD STAR DISTRIBUTION
Potential exposure
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Health & Personal Care
HIGH
FDA DRUG

Gold Star Distribution Recalls Alka Seltzer Over Rodent Contamination

Gold Star Distribution recalled Alka Seltzer on December 26, 2025, due to insanitary conditions at their distribution center. The recall affects Original and Plus Cold & Flu formulations sold in various packaging. Consumers should stop using the product immediately due to potential health risks.

GOLD STAR DISTRIBUTION
CGMP Deviations:
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Health & Personal Care
HIGH
FDA DRUG

Tylenol Recall by Gold Star Distribution Affects 5 SKUs in 2026

Gold Star Distribution is recalling Tylenol products distributed nationwide. The recall concerns CGMP deviations and insanitary conditions at the distributor’s facility. Consumers should stop using these Tylenol products immediately and contact Gold Star Distribution for guidance.

Gold Star Distribution
CGMP Deviations:
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Health & Personal Care
HIGH
FDA DEVICE

Medline Suction Catheter Kits Recalled Due to Serious Health Risk

Medline Industries, LP recalled 141,971 suction catheter kits on December 24, 2025. The kits may contain a smaller catheter that can lead to serious respiratory issues. Health providers and patients must stop using the kits immediately to prevent potential harm.

Medline Industries, LP
A smaller
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Health & Personal Care
HIGH
FDA DEVICE

Medline Industries Issues Recall of Catheters Over Infection Risk

Medline Industries recalled 94 lots of Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters on December 22, 2025. The catheters may contain small particles that pose a risk of serious health issues. Users should stop using the devices immediately and follow manufacturer instructions for return.

Medline Industries, LP
These lots
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Health & Personal Care
HIGH
FDA DEVICE

Abbott Catheters Recalled Over Risk of Infection and Embolism

Abbott recalled reprocessed steerable diagnostic catheters on December 22, 2025, after discovering potential contamination. The devices may contain small particles that pose risks of systemic infection or embolism. A total of 311 units are affected nationwide.

Medline Industries, LP
These lots
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Health & Personal Care
HIGH
FDA DEVICE

Medline Industries Recalls Ultrasound Catheters Over Infection Risk

Medline Industries recalled 511 reprocessed AcuNav ultrasound catheters on December 22, 2025. These devices may contain small particles that can cause serious health risks such as systemic infections and embolisms. Healthcare providers must stop using the affected devices immediately to prevent potentially life-threatening complications.

Medline Industries, LP
These lots
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Health & Personal Care
HIGH
FDA DEVICE

Tyber Medical Recalls VOLT Wrist Treatment System Due to Hazard

Tyber Medical recalled 100 units of its VOLT Wrist Treatment System on December 19, 2025. The recall stems from a manufacturing defect that affects the thread orientation of anatomical left plates. Healthcare providers and patients should stop using the device immediately.

Tyber Medical
The supplier
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