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Everolimus Tablets 2.5mg (Endo USA) – Impurity Specification (2025)

Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.

Class IIILow

FDAOct 10, 2025Nationwide• Endo USA, Inc.

Elixir Mineral Sunscreen SPF 50 (CA BOTANA) – Quality Deviation (2025)

CGMP Deviations

Class IIModerate

FDAOct 10, 2025CA, CO, FL +2 more• CA BOTANA International, Inc.

Everolimus Tablets 5mg (Endo USA) – Impurity Specification (2025)

Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.

Class IIILow

FDAOct 10, 2025Nationwide• Endo USA, Inc.

bk3500 Ultrasound System (B-K Medical) – Battery Replacement Warning (2025)

GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.

Moderate

FDAOct 9, 2025Nationwide• B-K Medical A/S Mileparken 34 Herlev Denmark

bk3000 Ultrasound System (B-K Medical) – Battery Replacement Warning (2025)

Moderate

FDAOct 9, 2025Nationwide• B-K Medical A/S Mileparken 34 Herlev Denmark

Ultrasound System 2300 (B-K Medical) – Battery Replacement Warning (2025)

Moderate

FDAOct 9, 2025Nationwide• B-K Medical A/S Mileparken 34 Herlev Denmark

bk5000 Ultrasound System (B-K Medical) – Battery Replacement Warning (2025)

Moderate

FDAOct 9, 2025Nationwide• B-K Medical A/S Mileparken 34 Herlev Denmark

SJM Pericardial Patch (Glycar) – Tensile Strength Issue (2025)

The impacted lot may not meet the required tensile strength specification.

Moderate

FDAOct 9, 2025Nationwide• Glycar SA Pty., Ltd.

Ultrasound System 1300 (B-K Medical) – Battery Replacement Warning (2025)

Moderate

FDAOct 9, 2025Nationwide• B-K Medical A/S Mileparken 34 Herlev Denmark

1202 Flex Focus Ultrasound (B-K Medical) – Battery Replacement Warning (2025)

Moderate

FDAOct 9, 2025Nationwide• B-K Medical A/S Mileparken 34 Herlev Denmark

Myosa for Kids (Myofunctional) – Unauthorized Distribution (2025)

Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval.

Moderate

FDAOct 9, 2025Nationwide• Myofunctional Research Company USA

Sucralfate Tablets (Amerisource) – Quality Management (2025)

CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.

Class IIModerate

FDAOct 9, 2025Nationwide• Amerisource Health Services LLC

Roshni Cinnamon Powder (Singh Trading) – heavy metals (2025)

Product may contain elevated levels of lead and chromium.

Class IIModerate

FDAOct 9, 2025FL, MD, NC +2 more• Singh Trading Inc. DBA Roshni Foods

Motion Sickness Patches (ibspot) – Unapproved Marketing (2025)

Marketed Without an Approved NDA/ANDA

Class IIModerate

FDAOct 9, 2025VA, WY• ibspot

HeartMate 3 (Thoratec) – Battery Cable Corrosion (2025)

Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.

Moderate

FDAOct 9, 2025Nationwide• Thoratec LLC

Ketamine HCl Injection (STAQ Pharma) – Labeling Issue (2025)

Labeling: Incorrect or Missing Lot and/or Exp Date

Class IIILow

FDAOct 9, 2025Nationwide• STAQ Pharma, Inc.

Hydromorphone HCL PF Injection (STAQ Pharma) – Labeling Error (2025)

Labeling: Incorrect or Missing Lot and/or Exp Date

Class IIILow

FDAOct 9, 2025Nationwide• STAQ Pharma, Inc.

Quantum Intersegmental Table (Pivotal Health) – Heat Function Risk (2025)

The heat function may become damaged over time due to patients pressing on the areas with heat function components. Damage to components can lead to overheating which can lead to smoldering and melting of the vinyl cushion.

Moderate

FDAOct 9, 2025Nationwide• Pivotal Health Solutions, Inc.

Olopatadine Ophthalmic Solution (USV) – Impurity Concern (2025)

Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.

Class IIModerate

FDAOct 9, 2025Nationwide• USV Private Limited

Aojia Dried Red Bayberry (Rong Shing) – undeclared additives (2025)

Undeclared Allergen

Product contains undeclared sulfites (7.39mg/serving) and cyclamates

Class IIModerate

FDAOct 9, 2025MA, NJ, NY +1 more• Rong Shing Trading NY Inc

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