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Exela Pharma Sciences LLC

Exela Pharma Sciences LLC Recalls

All product recalls associated with Exela Pharma Sciences LLC.

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Recall Summary

Total Recalls

Past Year

Class I (Serious)

Most Recent

Jul 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–5 of 5 recalls

Sodium Bicarbonate Injection (Exela Pharma) – Arsenic Impurities (2025)

Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.

Class IIModerate

FDAJul 30, 2025Nationwide• Exela Pharma Sciences LLC

Sodium Bicarbonate Injection (Exela Pharma) – Sterility Concern (2025)

Lack of Assurance of Sterility

Class IIModerate

FDAMar 7, 2025Nationwide• Exela Pharma Sciences LLC

Midazolam Injection (Exela Pharma) – Particulate Problem (2023)

Presence of Particulate Matter: Silicone

Class I

High

FDAOct 18, 2023Nationwide• Exela Pharma Sciences LLC

ELCYS Injection (Exela Pharma) – Particulate Contamination (2023)

Presence of Particulate Matter: Silicone

Class IHigh

FDAOct 18, 2023Nationwide• Exela Pharma Sciences LLC

Sodium Bicarbonate Injection (Exela Pharma) – Particulate Issue (2023)

Presence of Particulate Matter: Silicone

Class IHigh

FDAOct 18, 2023Nationwide• Exela Pharma Sciences LLC