Glenmark Pharmaceuticals Inc. recalled 22,656 bottles of Theophylline extended-release tablets on August 8, 2025. The recall follows reports of failed dissolution specifications that could impact medication efficacy. Consumers should stop using the product and consult healthcare providers immediately.
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.
Consumers and healthcare providers should stop using this product immediately. Contact Glenmark Pharmaceuticals Inc., USA or your healthcare provider for guidance. Notification method: Letter
The recall affects Theophylline extended-release tablets, 400mg, in 100-count bottles. The products were manufactured by Glenmark Pharmaceuticals Limited in India and distributed nationwide in the USA.
The recall stems from failed dissolution specifications. The dissolution results did not comply with L3 stage criteria, potentially affecting the drug's effectiveness.
No injuries or adverse incidents have been reported associated with this recall. The potential for ineffective medication poses a serious health risk.
Stop using the recalled Theophylline tablets immediately. Contact Glenmark Pharmaceuticals Inc. for further guidance and potential refund options.
Consumers can reach Glenmark Pharmaceuticals Inc. at their website for more information. For additional assistance, consult with healthcare providers.
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