January 2025 FDA Recall Venlafaxine by Appco Pharma Llc
D-0208-2025 - Failed Tablet/Capsule Specifications

This Class III drug recall was voluntarily initiated by Appco Pharma Llc on January 16, 2025 for the product Venlafaxine. The FDA reported the reason for recall as failed tablet/capsule specifications. The product was distributed Nationwide and the recall is currently completed.

Recall Number: D-0208-2025

Reason for Recall
Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet
Initiated
01-16-2025
Reported
01-29-2025
Quantity
1380 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
96128
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Appco Pharma LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide USA.
Product Description About Product Description
Full technical description of the product.
Venlafaxine Extended-Release Tablets, 150mg, Rx only, 90 Tablets, Manufactured by Appco Pharma. LLC, NDC 43598-943-90.

Batch or Lot Expiration Information

Lot# : 2402101UR, Exp 02/28/2027

Affected Packages Involved in this Recall

43598-943-30 Venlafaxine
43598-943-90 Venlafaxine
43598-944-30 Venlafaxine
43598-944-90 Venlafaxine