Drug recall: Venlafaxine Extended-Release Tablets, 150mg, Rx only, 90 Tablets, Manufactured by Appco Pharma. LLC, NDC 43598-943-90.
Class III FDA enforcement event 96128. Recall start date: . Status in the FDA record: Completed.
Reason for recall, in the words of FDA
Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet
Class III, in the words of FDA
a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences
Appco Pharma LLC started this drug recall on 16 Jan 2025. The firm address in the FDA record is in Piscataway, NJ. FDA put the recall in Class III. FDA event 96128 has 1 product record. The first FDA enforcement report date is 29 Jan 2025. The record gives the status Completed.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Nationwide USA.
Recalling firm
Appco Pharma LLC, Piscataway, NJ.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0208-2025 | Venlafaxine Extended-Release Tablets, 150mg, Rx only, 90 Tablets, Manufactured by Appco Pharma. LLC, NDC 43598-943-90. | 1380 bottles | Class III | Completed | 29 Jan 2025 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class III: The lowest of the three FDA recall classes.
The event in context
- Drug events that started in 2025
- 322
- Share of these events in Class III
- 12%
- Product records in this event
- 1Median of the firm: 2
- Events of the firm on the register
- 3
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 27 Mar 2026 | Prazosin Hydrochloride Capsules, USP, 1mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, | Drug | Class II | 3 |
| 7 Jan 2020 | Ranitidine Capsules 300 mg, 30 count bottles. Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854, Distribu | Drug | Class II | 2 |
Official channels
- FDA enforcement report D-0208-2025The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 96128. https://recallregister.com/fda/iii/96128/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Nationwide USA.
- What quantity of product is in FDA event 96128?
- The FDA record gives this quantity:
1380 bottles
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2025 have the same class?
- 12% of the 322 drug events that started in 2025 are in Class III.