cpsc regulated Recalls

2,056 recalls tagged with “cpsc regulated”.

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 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 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 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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Health & Personal Care
HIGH
FDA FOOD

Hi-Tech Pharmaceuticals Beta Sitosterol 715mg Recalled for Unapproved Claims (2025)

Hi-Tech Pharmaceuticals recalled 85,950 units of Beta Sitosterol supplement distributed nationwide from Norcross, Georgia after regulators flagged unapproved drug claims and misbranding. The product claims cardiovascular support and cholesterol benefits without FDA approval. Consumers should not consume the product and should contact Hi-Tech Pharmaceuticals for refund or replacement by letter.

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

Hi-Tech Pharmaceuticals Quercetin Dietary Supplement Recalled for Unapproved Drug Claims and Misbrnd

Hi-Tech Pharmaceuticals recalled 85,950 units of its Quercetin dietary supplement distributed to 40+ states after FDA enforcement found unapproved drug claims and misbranding. The recall, active as of Aug 6, 2025, stems from regulatory concerns rather than a reported health incident. Consumers should stop using the product and contact the company for refunds or replacements.

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

Hi-Tech Pharmaceuticals Pine Bark Supplements Recalled for Unapproved Drug Claims and Misbranding (H

Hi-Tech Pharmaceuticals recalled 85,950 units of Pine Bark Supplements for unapproved drug claims and misbranding. The FDA enforcement notice lists Hi-Tech Pharmaceuticals, Inc. of Norcross, GA as the marketer. The recall cites unapproved drug claims and misbranding as the reason. Consumers should stop using the product and contact the company for refund or replacement information.

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

Hi-Tech Pharmaceuticals PrimeNutrition Taurine Recall 85,950 Units in 2025

Hi-Tech Pharmaceuticals recalled 85,950 units of PrimeNutrition Taurine Mental & Athletic Performance dietary supplement distributed nationwide. The FDA enforcement report cites unapproved drug claims and misbranding. Consumers who purchased this product should not consume it and should contact the company for refund or replacement.

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

Olympus ViziShot 2FLEX Biopsy Device Recalled for Deformed Tips in 103,731 Units

Olympus Corp of the Americas recalled 103,731 ViziShot 2FLEX single-use aspiration needles worldwide after officials flagged potential undetected, deformed atraumatic tips. The recall covers the NA-U403SX-4019 model. Healthcare providers must halt use immediately and follow manufacturer instructions for recall. Manufacturers say notification was by letter.

Olympus Corporation of the Americas
Potential for
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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 DEVICE

Boston Scientific UroMax Ultra Kit MPNs Recalled Over Foreign Material Migration Risk (2025)

Boston Scientific recalled 1,369 Encore 26 Inflation Devices used with balloon dilation catheters after an internal investigation found foreign material particles could migrate into a balloon dilatation catheter. The recall affects 12 UPNs including M0062251200 through M0062251370. Patients and healthcare providers should stop using the device immediately and follow manufacturer instructions.

Boston Scientific
The Encore
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Encore 26 Inflation Device Recalled Over Foreign Particle Contamination

Boston Scientific recalls 39,739 Encore 26 Inflation Devices worldwide after an internal investigation found foreign material particles could migrate from the device into balloon dilation catheters. The high-severity recall affects interventional cardiology and peripheral interventions devices. Stop using immediately and await recall instructions from Boston Scientific or healthcare providers.

Boston Scientific
The Encore
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Health & Personal Care
HIGH
FDA DEVICE

Philips Pinnacle3 Recall: 810 Units Over ROI Image Error in 2025

Philips Medical Systems recalled 810 Pinnacle Radiation Therapy Planning System units nationwide to healthcare providers. A software issue may cause an image error of the Region of Interest for HFP, FFS, and FFP orientations. Hospitals and clinics should stop using the software immediately and follow the manufacturer’s instructions.

Philips Medical Systems
Due to
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Food & Beverages
HIGH
FDA FOOD

Hans Kissle Company Recalls 66 Units of Red Bliss Potato Salad for Undeclared Wheat (2025)

Hans Kissle Company recalled 66 units of Red Bliss Potato Salad distributed in MA, RI, CT, NJ and NY. The recall is due to undeclared wheat and a mislabeling that identifies the product as potato salad while the unit contains pasta salad. Consumers should not eat the product and should contact Hans Kissle Company for refund or replacement via email.

Hans Kissle Company
Contains undeclared
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