Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate recall — FDA D-0660-2026
Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.
Overview of recall records associated with Lannett Company, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 6.
Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.
Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.
Presence of Foreign Tablet/Capsule: Two (2) bottles labeled as Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, 100ct,…
Failed Impurities/Degradation Specifications: Out of specification results for related substances.
Labeling: Label Mix Up: bottle labeled to contain Prednisone Tablets, USP 2.5 mg actually contained Prednisone Tablets, USP 10 mg
CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities.
This page summarizes recall records in which the official source identifies Lannett Company, Inc. 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.