Recalls / Class II
Class IID-0341-2026
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 50268-069-15.
- Brand name
- Amantadine Hcl
- Generic name
- Amantadine Hydrochloride
- Active ingredient
- Amantadine Hydrochloride
- Route
- Oral
- NDC
- 50268-069
- FDA application
- ANDA078720
- Affected lot / code info
- Lot # 49261, Exp: 04/30/27
Why it was recalled
Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
Recalling firm
- Firm
- AvKARE
- Manufacturer
- AvPAK
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 615 N 1st St, N/A, Pulaski, Tennessee 38478-2403
Distribution
- Quantity
- N/A
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2026-02-13
- FDA classified
- 2026-02-23
- Posted by FDA
- 2026-03-04
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0341-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.