cpsc regulated Recalls

1,716 recalls tagged with “cpsc regulated”.

Health & Personal Care
HIGH
FDA DEVICE

Medica Recalls Capillary Tube Kit Over False Potassium Readings

Medica recalled 1,578 units of its Capillary Tubes on December 31, 2025. A systematic positive bias of up to 20% can produce false elevation results in patient potassium levels. Healthcare providers and patients must stop using the device immediately.

Medica
A systematic
Read more
Health & Personal Care
HIGH
FDA DRUG

Alvogen Recalls Levothyroxine Sodium Tablets Due to Mix-Up

Alvogen, Inc. recalled Levothyroxine Sodium Tablets on January 21, 2026, after a pharmacy reported a mix-up with dosages. Some bottles contained 88 mcg tablets instead of the prescribed 150 mcg. The recall affects 1,000 tablets from lot # MHA21825, with an expiration date of December 31, 2027.

LEVOTHYROXINE SODIUM
Product Mix-Up:
Read more
Health & Personal Care
HIGH
FDA DRUG

Wizcure Pharmaa Recalls Eye Drops Due to Sterility Risk

Wizcure Pharmaa PVT. LTD. recalled 11,520 cartons of Vista Meibo Tears Eye Drops on December 31, 2025. The recall occurred due to lack of assurance of sterility, posing a high risk to consumers. The affected product was distributed nationwide in the USA.

VISTA MEIBO TEARS PROPYLENE GLYCOL 0.6% W/V ADVANCED DRY EYE RELIEF LUBRICATING DROPS 10 ML
Lack of
Read more
Health & Personal Care
HIGH
FDA DRUG

Wizcure Pharmaa Recalls Ophthalmic Strips Over Sterility Concerns

Wizcure Pharmaa recalled 50,400 boxes of Bio Glo Fluorescein Sodium Ophthalmic Strips on December 31, 2025. The recall follows concerns regarding lack of assurance of sterility, as products did not conform to good manufacturing practices. Consumers should stop using the product immediately and consult healthcare providers.

Wizcure Pharmaa Private
Lack of
Read more
Health & Personal Care
HIGH
FDA DEVICE

Miach Orthopaedics Recalls BEAR Implant Over Expiration Date Error

Miach Orthopaedics recalled 284 units of the BEAR Implant, Model Number 1000, on December 31, 2025. The recall stems from an incorrect expiration date on the label that exceeds the product's approved shelf life. Patients and healthcare providers should stop using the device immediately and follow recall instructions.

Miach Orthopaedics
Incorrect expiration
Read more
Health & Personal Care
HIGH
FDA DRUG

Wizcure Pharmaa Recalls Vista Gonio Eye Lubricant Over Sterility Issues

Wizcure Pharmaa Pvt. Ltd. recalled 139,104 cartons of Vista Gonio Eye Lubricant on December 31, 2025. The recall stems from a lack of assurance of sterility due to non-compliance with manufacturing practices. Consumers are urged to stop using the product immediately and seek guidance from healthcare providers.

VISTA GONIO EYE LUBRICANT
Lack of
Read more
Health & Personal Care
HIGH
FDA DEVICE

Medline Industries Recalls IV Administration Sets Due to Leakage Risk

Medline Industries recalled over 926,000 IV Administration and Extension Sets due to a significant risk of leaks and breaks. The recall affects multiple models with potential exposure to chemicals and mechanical forces. Users should discontinue use immediately to prevent serious health risks including blood loss and infections.

Medline Industries, LP
Under circumstances
Read more
Health & Personal Care
HIGH
FDA DEVICE

Intuitive Surgical Recalls da Vinci 5 Display Over High Injury Risk

Intuitive Surgical recalled 47 da Vinci 5 Surgeon Console Viewer Displays on December 30, 2025. The devices may lose display functionality, risking surgical injury. Healthcare providers should stop using the consoles immediately and follow recall instructions.

Intuitive Surgical
Robotic-assisted surgical
Read more
Health & Personal Care
HIGH
FDA DRUG

Sun Pharmaceutical Fluocinolone Acetonide Topical Solution Recall 24,624 Bottles (2025)

Sun Pharmaceutical Industries is recalling 24,624 bottles of Fluocinolone Acetonide Topical Solution nationwide after out-of-spec impurity D was detected. The product is distributed by Taro Pharmaceuticals in the United States and labeled Rx-only. Consumers must stop using the product and consult a healthcare provider for guidance.

Fluocinolone Acetonide
Failed Impurities/Degradation
Read more
Health & Personal Care
HIGH
FDA DRUG

Glenmark Pharmaceuticals Recalls Ondansetron Tablets Over Packaging Issues

Glenmark Pharmaceuticals recalled nearly 97,000 packs of Ondansetron Orally Disintegrating Tablets on December 30, 2025. Defective blister packs may not fully seal, leading to tablets falling out. Consumers should stop using the product immediately and contact healthcare providers.

ONDANSETRON
Defective container:
Read more
Health & Personal Care
HIGH
FDA DRUG

Zydus Pharmaceuticals Recalls Icosapent Ethyl Capsules Over Subpotency

Zydus Pharmaceuticals recalled 22,896 bottles of Icosapent Ethyl capsules on December 30, 2025. The recall stems from leakage and oxidation that may reduce the drug's effectiveness. Consumers should stop using the product immediately and seek guidance from healthcare providers.

Zydus Pharmaceuticals
Subpotent Drug:
Read more
Health & Personal Care
HIGH
FDA DEVICE

Siemens X-Ray System Recalled Due to Image Processing Errors

Siemens Medical Solutions USA recalled five LUMINOS Q.namix T X-ray systems on December 29, 2025. The recall affects devices that can process images from previous patients due to a software issue. Healthcare providers must stop using these devices immediately.

Siemens Medical Solutions USA
Ortho images
Read more
Health & Personal Care
HIGH
FDA DEVICE

Cerapedics Recalls Bone Graft Due to Incorrect Expiration Date

Cerapedics recalled 237 units of PearMatrix P-15 Peptide Enhanced Bone Graft on December 29, 2025. The recall affects products distributed nationwide after a review revealed incorrect expiration dates. Patients and healthcare providers should stop using the product immediately.

Cerapedics
Incorrect expiration
Read more
Health & Personal Care
HIGH
FDA DRUG

Gold Star Distribution Recalls Claritin Over Rodent Contamination

Gold Star Distribution recalled Claritin, 20 Count, on December 26, 2025, due to insanitary conditions resulting from rodent exposure. The recall affects an unknown quantity distributed nationwide. Consumers should stop using the product immediately.

GOLD STAR DISTRIBUTION
CGMP Deviations:
Read more
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:
Read more
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:
Read more
Health & Personal Care
HIGH
FDA DEVICE

Gold Star Distribution Recalls Toothbrushes and Toothpaste Over Rodent Exposure

Gold Star Distribution recalled toothbrushes and toothpaste on December 26, 2025, due to potential rodent exposure. The recall affects products distributed nationwide, particularly in Minnesota. Consumers should stop using these items immediately and follow recall instructions.

GOLD STAR DISTRIBUTION
Potential exposure
Read more
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:
Read more
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:
Read more