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Drug FDA Class III Completed Mislabeling

Venlafaxine Extended-Release Tablets, 150mg, Rx only, 90 Tablets, Manufactured by Appco Pharma. LLC, NDC 43598-943-90.

Appco Pharma LLC Published Jan 29, 2025

Risk level

Class III

Unlikely to cause harm, but violates labeling or manufacturing rules.

Severity score 35/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Appco Pharma LLC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet

Affected products (1)

Venlafaxine Extended-Release Tablets, 150mg, Rx only, 90 Tablets, Manufactured by Appco Pharma. LLC, NDC 43598-943-90.

VENLAFAXINE · 1380 bottles

NDC: 43598-943, 43598-944, 43598-943-30, 43598-943-90, 43598-944-30, 43598-944-90
Code info: Lot #: 2402101UR, Exp 02/28/2027

Affected areas

Nationwide

Timeline

  1. Initiated
    Jan 16, 2025
  2. Published
    Jan 29, 2025
Recall number
D-0208-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.