Aidarex Pharmaceuticals LLC Recalls

All product recalls associated with Aidarex Pharmaceuticals LLC.

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Recall Summary

Total Recalls

10

Past Year

0

Class I (Serious)

0

Most Recent

Jun 2018

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 1–10 of 10 recalls

Enalapril Maleate 5mg (Aidarex) – degradation product (2018)

Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.

Class IIILow

FDAJun 27, 2018Nationwide• Aidarex Pharmaceuticals LLC

Enalapril Maleate 5mg 90-count (Aidarex) – degradation product (2018)

Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.

Class IIILow

FDAJun 27, 2018Nationwide• Aidarex Pharmaceuticals LLC

Enalapril Maleate 2.5mg (Aidarex) – degradation product (2018)

Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.

Class III

Low

FDAJun 27, 2018Nationwide• Aidarex Pharmaceuticals LLC

Ferrous Sulfate Tablet (Aidarex) – Foreign Tablet Contamination (2018)

Presence of Foreign Tablets/Capsules

Class IIILow

FDAApr 10, 2018FL• Aidarex Pharmaceuticals LLC

Enalapril Maleate Tablets (Aidarex) – Impurity Specification (2017)

Failed Impurities/Degradation Specifications: manufacturer of product recalled this repackaged lot due to out of specification results for related compound.

Class IIILow

FDASep 5, 2017FL, IN• Aidarex Pharmaceuticals LLC

Phentermine Capsules (Aidarex) – Impurity Specification Failure (2017)

Failed Impurities/Degradation Specification; out-of-specification results for individual unknown impurities at the 30 month Room Temperature Retained Sample stability test

Class IIILow

FDASep 5, 2017CA, NV• Aidarex Pharmaceuticals LLC