Recalls / Class III
Class IIID-0208-2025
Product
Venlafaxine Extended-Release Tablets, 150mg, Rx only, 90 Tablets, Manufactured by Appco Pharma. LLC, NDC 43598-943-90.
- Brand name
- Venlafaxine
- Generic name
- Venlafaxine
- Active ingredient
- Venlafaxine Hydrochloride
- Route
- Oral
- NDCs
- 43598-943, 43598-944
- FDA application
- ANDA214609
- Affected lot / code info
- Lot #: 2402101UR, Exp 02/28/2027
Why it was recalled
Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet
Recalling firm
- Firm
- Appco Pharma LLC
- Manufacturer
- Dr. Reddy's Laboratories Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 262 Old New Brunswick Rd Unit N, Piscataway, New Jersey 08854-3756
Distribution
- Quantity
- 1380 bottles
- Distribution pattern
- Nationwide USA.
Timeline
- Recall initiated
- 2025-01-16
- FDA classified
- 2025-01-23
- Posted by FDA
- 2025-01-29
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0208-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.