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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.

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.

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

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

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

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

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

Sucralfate Tablets (Amerisource) – Quality Management (2025)

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

Duloxetine Capsules 60mg (Breckenridge) – Impurity Concerns (2025)

Fasenra Injection (AstraZeneca) – Sterility Risk (2025)

Prazosin Hydrochloride Capsules 2mg (Teva) – Impurity Concerns (2025)

Prazosin Hydrochloride Capsules 5mg (Teva) – Impurity Concerns (2025)

Carbidopa Levodopa Entacapone Tablets (Rising Pharma) – Product Mix-up (2025)

Prazosin Hydrochloride Capsules 1mg (Teva) – Impurity Concerns (2025)

Desipramine Tablets 10mg (Heritage) – Impurity Concerns (2025)

Desipramine Tablets 75mg (Heritage) – Impurity Concerns (2025)

Desipramine Tablets 25mg (Heritage) – Impurity Concerns (2025)

Desipramine Tablets 150mg (Heritage) – Impurity Concerns (2025)

Desipramine Tablets 100mg (Heritage) – Impurity Concerns (2025)

Tavaborole Topical Solution 5% (Viona) – Discoloration (2025)

Desipramine Tablets 50mg (Heritage) – Impurity Concerns (2025)

Ketorolac Injection (Aspiro Pharma) – Glass Particulate (2025)

Doxycycline Hyclate Tablets 100mg (Acella) – Dissolution Failure (2025)

Succinylcholine Chloride Injection (Dr. Reddy's) – Stability Issue (2025)