AvKARE Issues Voluntary Recall for Amantadine HCl Capsules Due to Dissolution Failure
AvKARE has initiated a voluntary recall of Amantadine HCl Capsules, 100 mg, after the product failed to meet dissolution specifications during testing.
What Happened
AvKARE has initiated a voluntary recall of Amantadine HCl Capsules, USP, 100 mg. The recall was triggered by an “Out of Specification” finding during dissolution testing. This failure to meet dissolution specifications means the medication may not break down as intended once ingested.
Which Products Are Affected
The recall affects the following specific product lot distributed nationwide across the United States:
- Product Name: Amantadine HCl, Capsules, USP, 100 mg
- Configuration: 50 Capsules (5 x 10) unit dose
- NDC Number: 50268-069-15 (associated with package NDCs 50268-069-11 and 50268-069-15)
- Lot Number: 49261
- Expiration Date: 04/30/27
- Recall Number: D-0341-2026
The product was manufactured for AvKARE, based in Pulaski, Tennessee.
What You Should Do
Consumers, pharmacists, and healthcare providers should immediately check their inventory for Lot # 49261. If you have the affected product, you should stop using or distributing it. For information regarding returns or further instructions, contact AvKARE at their Pulaski, TN office or visit their official website at www.avkare.com. The firm originally notified affected parties via letter starting on February 13, 2026.
Why This Matters
Dissolution specifications are critical for ensuring that a drug is absorbed by the body at the correct rate and concentration. A failure in dissolution can impact the therapeutic effectiveness of the prescription medication.
Source
Information provided by the U.S. Food and Drug Administration (FDA).
Source: FDA Official Notice