Venlafaxine Extended-Release Tablets recall
FDA recall D-0208-2025 · initiated Jan 16, 2025
Appco Pharma LLC recalled Venlafaxine Extended-Release Tablets in Jan 2025 — an FDA Class III recall (D-0208-2025) because Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 1380 bottles
Details
- Product
- Venlafaxine Extended-Release Tablets, 150mg, Rx only, 90 Tablets, Manufactured by Appco Pharma. LLC, NDC 43598-943-90.
- Recalling company
- Appco Pharma LLC
- Classification
- Class III
- Status
- Completed
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide USA.
- Initiated
- Jan 16, 2025
- FDA report date
- Jan 29, 2025
Frequently asked
- Was Venlafaxine Extended-Release Tablets recalled?
- Appco Pharma LLC recalled Venlafaxine Extended-Release Tablets in Jan 2025 — an FDA Class III recall (D-0208-2025) because Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Venlafaxine Extended-Release Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0208-2025 was: Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet
- Is a recalled Venlafaxine Extended-Release Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Venlafaxine Extended-Release Tablets are affected?
- Distributed: Nationwide USA.. The recall covers these lots — Lot #: 2402101UR, Exp 02/28/2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0208-2025.