FDA recall, , Moderate risk
AvKARE Amantadine HCl Capsules
Amantadine HCl capsules failed dissolution specifications.
Summary by Recall Canary from the FDA notice
What happened
AvKARE, of Pulaski, Tennessee, initiated a recall on February 13, 2026, of Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, because of an Out of Specification finding in dissolution. The product was distributed nationwide in the USA. The FDA added the recall to its Enforcement Report on February 23, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
- NDC
- 50268-069-15
- Lot code
- 49261
Recall details
- Company began the recall
- Sold in
Nationwide in the USA.
- Company
- AvKAREPulaski, Tennessee
- Hazard
- Drug dissolving problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98449
- Recall number
- D-0341-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
