Why it was recalled
Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
Product description
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 50268-069-15.
Lot numbers, UPCs & expiration codes
Lot # 49261, Exp: 04/30/27
Where it was sold
Nationwide in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0341-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Feb 13, 2026
- FDA report date
- Mar 4, 2026
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AvKARE
Original FDA data
Every field from FDA enforcement report D-0341-2026, exactly as published.
Show all FDA fields
- City
- Pulaski
- State
- TN
- Status
- Ongoing
- Country
- United States
- Event ID
- 98449
- Address
- 615 N 1st St
- Code information
- Lot # 49261, Exp: 04/30/27
- Postal code
- 38478-2403
- Report date
- Mar 4, 2026
- Product type
- Drugs
- Recall number
- D-0341-2026
- Classification
- Class II
- Recalling firm
- AvKARE
- Reason for recall
- Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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 50268-069-15.
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Feb 13, 2026
- Initial firm notification
- Letter
- Center classification date
- Feb 23, 2026