cpsc regulated Recalls

2,048 recalls tagged with “cpsc regulated”.

Health & Personal Care
HIGH
FDA DEVICE

Medline Industries Recalls 22 Sterile Convenience Kits DYNJ0382730O, DYNJ61038B (2025)

Medline Industries, LP recalled 22 sterile convenience kits distributed to Florida, Maryland, New Jersey and Tennessee after determining the kits labeled as sterile had not undergone sterilization. The sterility lapse creates an infection risk for patients. Healthcare facilities and patients should stop using the kits and follow the recall instructions from Medline and the FDA.

Medline Industries
Convenience kits
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Health & Personal Care
HIGH
FDA DEVICE

Medline Medline Extremity Pack DYNJ45701B Sterile Kit Recall Affects 88 Units (2025)

Medline Industries recalled 88 units of the Sterile Extremity Pack DYNJ45701B after finding that kits labeled as sterile had not undergone sterilization. The affected distribution covered Florida, Maryland, New Jersey and Tennessee. Hospitals and clinics should stop using the kit immediately and follow Medline's recall instructions.

Medline Industries
Convenience kits
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Health & Personal Care
HIGH
FDA DRUG

Glenmark Carvedilol 25 mg Recall for Nitrosamine Impurity Affects 4,800 Bottles (2025)

Glenmark Pharmaceuticals recalls 4,800 bottles of Carvedilol 25 mg tablets distributed nationwide in the USA. The recall cites CGMP deviations and a nitrosamine impurity exceeding the Acceptable Intake Level. Consumers should stop using the product and contact Glenmark or their healthcare provider for guidance.

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

Glenmark Carvedilol Tablets Recalled Over Nitrosamine Impurity

Glenmark Pharmaceuticals Inc. recalls 6,432 bottles of Carvedilol Tablets, USP, 12.5 mg, distributed nationwide in the United States. The recall concerns CGMP deviations and the presence of a nitrosamine impurity above the acceptable intake level. Consumers should stop taking the product and contact Glenmark for guidance.

Glenmark Pharmaceuticals Inc.
CGMP Deviations:
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Recalled La Ligne Enfant Bonne Nuit Pajamas in Navy with White Trim
HIGH
CPSC

La Ligne Enfant Bonne Nuit Pajamas Recalled for Burn Hazard in 2025

La Ligne recalls Enfant Bonne Nuit children’s pajamas after a burn hazard was identified. The recall covers La Ligne by La Ligne Enfant Bonne Nuit two-piece sets sold in various colors. Consumers should stop using the pajamas and pursue a full refund or store credit.

La Ligne
The recalled
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Recalled Séfralls Minoxidil Hair Generation Serum
CRITICAL
CPSC

Séfralls Minoxidil Hair Generation Serum Recalled for Child Poisoning Risk (2025)

Séfralls Minoxidil Hair Generation Serum, sold by Guangzhou Ariel Biotech, was recalled on August 7, 2025. The serum is packaged in amber dropper bottles with a white and gold dropper and a white, black and gold label. The packaging is not child-resistant, violating the Poison Prevention Packaging Act and creating a poisoning risk for children. Consumers should stop using the serum immediately and

Séfralls
The hair
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Food & Beverages
HIGH
FDA FOOD

Hi-Tech Pharmaceuticals’ PrimeNutrition PhytoForm Fruits & Greens Recall for Unapproved Drug Claims

Hi-Tech Pharmaceuticals recalled 85,950 units of PrimeNutrition PhytoForm Fruits & Greens Formula after FDA enforcement flagged unapproved drug claims and misbranding. The dietary supplement was distributed to 40+ states before the recall was issued on 2025-08-06 and remains active. Consumers should not consume the product and should seek refund or replacement from Hi-Tech Pharmaceuticals.

Hi-Tech Pharmaceuticals
Unapproved Drug
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Health & Personal Care
HIGH
FDA FOOD

Hi-Tech Pharmaceuticals Adderex XR Recall 85,950 Units for Unapproved Claims (2025)

Hi-Tech Pharmaceuticals recalled 85,950 units of Adderex XR Strongest Focusing Aid sold nationwide after regulators found unapproved drug claims and misbranding. The product claims to boost concentration without a prescription. Consumers who bought the product should not use it and should contact the company for a refund or replacement.

Hi-Tech Pharmaceuticals
Unapproved Drug
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Health & Personal Care
HIGH
FDA FOOD

Hi-Tech Pharmaceuticals Dietary Supplement LG Sciences Battle Hardener Platinum Series Recall for Un

Hi-Tech Pharmaceuticals recalled 85,950 units of the LG Sciences Battle Hardener Platinum Series Complete 6 Week Cycle dietary supplement due to unapproved drug claims. The recall targets states across the U.S. The company is listed as Hi-Tech Pharmaceuticals. The remedy is a refund or replacement after notification by letter.

Hi-Tech Pharmaceuticals
Unapproved Drug
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Health & Personal Care
HIGH
FDA FOOD

Hi-Tech Pharmaceuticals Formutech Nutrition Joint Formula Recalled for Unapproved Drug Claims (2025)

Hi-Tech Pharmaceuticals recalled 85,950 units of Formutech Nutrition Flexible Joint Formula with Cissus Quadrangularis sold nationwide after regulators flagged unapproved drug claims. The product claims to support tendons and muscles and promote healthy cartilage, which regulators say is not approved. Consumers who purchased the supplement should not use it and should await refund or replacement,'

Hi-Tech Pharmaceuticals
Unapproved Drug
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Health & Personal Care
HIGH
FDA DRUG

Glenmark Carvedilol 12.5 mg Tablets Recalled for NNCI Impurity Exceeding FDA Limit (2025)

Glenmark Pharmaceuticals Inc., USA recalls 17,496 bottles of Carvedilol tablets sold nationwide after NNCI impurity exceeded FDA limits. The recall covers lot numbers 17241257, 17241258, and 17241279 with Exp. Date 06/2026. Consumers should stop using the product and contact Glenmark or their healthcare provider for guidance.

Glenmark Pharmaceuticals Inc.
CGMP Deviations:
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Food & Beverages
HIGH
FDA FOOD

Hi-Tech Pharmaceuticals Recalls PrimeNutrition PhytoForm Fruits & Greens Formula 30 Servings for Unf

Hi-Tech Pharmaceuticals recalled 85,950 units of PrimeNutrition PhytoForm Fruits & Greens Formula dietary supplement on Aug. 6, 2025. The product was manufactured by Prime Nutrition and distributed nationwide. The recall cites unapproved drug claims and misbranding. Consumers should not use the product and should contact Hi-Tech Pharmaceuticals for refund or replacement.

Hi-Tech Pharmaceuticals
Unapproved Drug
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