American Health Packaging recalled 360 cartons of Carbamazepine Extended-Release Tablets on September 15, 2025. The tablets fail to meet dissolution specifications, posing a risk to patients. Consumers should stop using the product immediately and consult healthcare providers for guidance.
Failed Dissolution Specifications.
Consumers and healthcare providers should stop using this product immediately. Contact Amerisource Health Services LLC or your healthcare provider for guidance. Notification method: Letter
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The recall involves Carbamazepine Extended-Release Tablets, USP 400 mg, sold in cartons of 30 tablets. Lot number 1024078, with an expiration date of August 31, 2026, was distributed nationwide.
The products do not meet necessary dissolution specifications. This failure can lead to inadequate therapeutic effects or unexpected side effects.
No specific incidents or injuries have been reported related to this recall as of now. The risk is classified as high due to potential adverse health effects.
Stop using the recalled product immediately. Contact Amerisource Health Services LLC or your healthcare provider for further instructions.
For more information, visit the FDA's website at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0675-2025.
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