CLASS III Drug recall · Reported 29 Jan 2025 · FDA Enforcement Report
Venlafaxine Extended-Release Tablets, 150mg recalled by Appco Pharma
Appco Pharma is recalling Venlafaxine Extended-Release Tablets, 150mg, distributed nationwide in the US. The recall was initiated on 16 Jan 2025 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0208-2025
- FDA event ID
- 96128
- Recalling firm
- Appco Pharma, Piscataway, NJ
- Brand
- Venlafaxine
- Manufacturer
- Dr. Reddy's Laboratories Inc.
- Classification
- Class III
- Status
- Completed
- Recall initiated
- 16 Jan 2025
- FDA classified
- 23 Jan 2025
- Reported
- 29 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Antidepressants
Timeline
| 16 Jan 2025 | Recall initiated by company | |
| 23 Jan 2025 | Classified by FDA | +7 days |
| 29 Jan 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet
Product as listed by the FDA
Venlafaxine Extended-Release Tablets, 150mg, Rx only, 90 Tablets, Manufactured by Appco Pharma. LLC, NDC 43598-943-90.
Where it was distributed
Nationwide USA.
Questions about this recall
Why was it recalled?
Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet
Which lots are affected?
Lot #: 2402101UR, Exp 02/28/2027
Where was it sold?
Nationwide USA.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Appco Pharma
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Prazosin Hydrochloride Capsules, USP, 5mg recalled by Appco PharmaPrazosin Hydrochloride | Appco Pharma | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Prazosin Hydrochloride Capsules, USP, 2mg recalled by Appco PharmaPrazosin Hydrochloride | Appco Pharma | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Prazosin Hydrochloride Capsules, USP, 1mg recalled by Appco PharmaPrazosin Hydrochloride | Appco Pharma | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Ranitidine Capsules 150 mg, (a) bottles recalled by Appco Pharma | Appco Pharma | Nitrosamine Impurity | NJ |
| Drug | CLASS II | Ranitidine Capsules 300 mg recalled by Appco Pharma | Appco Pharma | Nitrosamine Impurity | NJ |
Other Venlafaxine recalls
All 26| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Venlafaxine Tablets, USP, 75 mg recalled by Zydus Pharmaceuticals (USA)Venlafaxine | Zydus Pharmaceuticals | Foreign Material | Nationwide |
| Drug | CLASS II | Venlafaxine Hydrochloride Extended-Release Capsules, USP 37.5mg recalledVenlafaxine Hydrochloride | Zydus Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Venlafaxine Hydrochloride, extended-release capsules recalled | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Venlafaxine Tablets, USP 50 mg* recalled | SUN Pharmaceutical Industries | Other | TN |
| Drug | CLASS II | Venlafaxine Hydrochloride Extended-Release Capsules USP, 75 mg recalled | Lucid Pharma | Packaging Defects | Nationwide |