← FDA ENFORCEMENT
D-0443-2024Class III
Novitium Pharma LLC
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Recalling firm
Novitium Pharma LLC
Product type
Drug
Status
Terminated
Report date
2024-04-24
Distribution
U.S. Nationwide
Firm state
NJ
Product quantity
1,003 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & QualificationReason for recall
Failed Impurities/Degradation Specifications
Product description
Digoxin Tablets, USP 62.5 mcg (0.0625 mg), 100-count bottles, Rx Only, Manufactured by: Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520, NDC 70954-200-10
Code / lot info
Lot M23011A; Exp. 12/2024
Other recalls SPEQ maps to Validation & Qualification
2026-10-21Class IIZydus Pharmaceuticals (USA) Inc2026-10-21Class IIIMagellan Diagnostics, Inc.2026-10-21Class IIMicrogenics Corporation2026-10-14Class IICipla USA, Inc.
See all Validation & Qualification recalls →Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →