Amantadine HCl recall: Failed Dissolution
Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, www.avkare.com, NDC…
Why was Amantadine HCl recalled?
Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # 49261, Exp: 04/30/27
- Product
- Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, www.avkare.com, NDC…
- Recalling firm
- AvKARE
- Quantity
- N/A
- Distribution
- Nationwide in the USA.
- Recall date
- March 4, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)