AvKARE recalled Amantadine HCl capsules on February 13, 2026, due to failed dissolution specifications. The recall affects the 100 mg capsules, which may not dissolve properly. Consumers should stop using this product and contact their healthcare provider immediately.
Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
Consumers and healthcare providers should stop using this product immediately. Contact AvKARE or your healthcare provider for guidance. Notification method: Letter
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The recalled product is Amantadine HCl capsules, 100 mg, sold in units of 50 capsules. The affected lot number is 49261 with an expiration date of April 30, 2027. These capsules were distributed nationwide in the USA.
The recall was initiated due to an Out of Specification finding in dissolution. This means that the capsules may not release the active ingredient as intended, potentially leading to ineffective treatment.
Stop using the recalled Amantadine HCl capsules immediately. Contact AvKARE or your healthcare provider for further guidance and possible return instructions.
For more information, call AvKARE at [insert phone number] or visit www.avkare.com. Additional details can be found on the FDA website.
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