THEOPHYLLINE

Wed Aug 20 2025

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Reason for Recall

Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for commercial annual stability at the long-term shelf life stability interval, wherein the dissolution results do not comply with L3 stage dissolution criteria.

Manufacturers

Drug	Manufacturer
THEOPHYLLINE	Glenmark Pharmaceuticals Inc., USA

Number of affected units

22,656 bottles

Distribution pattern

USA nationwide.

UPCs

UPC
0368462380017
0368462356012

Package NDCs

NDC
68462-380-01
68462-380-05
68462-356-01
68462-356-05

THEOPHYLLINE

Reason for Recall

Manufacturers

Number of affected units

Distribution pattern

UPCs

Package NDCs

Comments (-)

Comments (-)

THEOPHYLLINE

Reason for Recall

Manufacturers

Number of affected units

Distribution pattern

UPCs

Package NDCs

Comments (-)

Comments (-)

Comments (-)

THEOPHYLLINE

Reason for Recall

Manufacturers

Number of affected units

Distribution pattern

UPCs

Package NDCs

Comments (-)

THEOPHYLLINE

Reason for Recall

Manufacturers

Number of affected units

Distribution pattern

UPCs

Package NDCs

THEOPHYLLINE

Reason for Recall

Manufacturers

Number of affected units

Distribution pattern

UPCs

Package NDCs

THEOPHYLLINE

Reason for Recall

Manufacturers

Number of affected units

Distribution pattern

UPCs

Package NDCs