Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose recall — FDA D-0341-2026
Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
Overview of recall records associated with AvKARE, including dates, categories and classifications where available.
Classification mix: Class II: 4.
Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
Failed Content Uniformity Specifications
Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules
Subpotent Drug: Out of Specification (OOS) result for De hydro Impurity (0.654%) for 18 M Stability sample and low assay 94.9% (specification of NLT 95.0% NMT 105%)
This page summarizes recall records in which the official source identifies AvKARE as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.