CLASS II Drug recall · Reported 18 Aug 2021 · FDA Enforcement Report
Venlafaxine Tablets, USP 50 mg* recalled
Sun Pharmaceutical Industries is recalling Venlafaxine Tablets, USP 50 mg*, distributed in Tennessee. The recall was initiated on 29 Jul 2021 and the FDA has classified it as Class II.
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-0703-2021
- FDA event ID
- 88376
- Recalling firm
- Sun Pharmaceutical Industries, Princeton, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Jul 2021
- FDA classified
- 6 Aug 2021
- Reported
- 18 Aug 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Antidepressants
Timeline
| 29 Jul 2021 | Recall initiated by company | |
| 6 Aug 2021 | Classified by FDA | +8 days |
| 18 Aug 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Forein Tablets/Capsules; Venlafaxine Tablets, USP 37.5 mg found in bottles labeled as Venlafaxine Tablets, USP, 50 mg
Product as listed by the FDA
Venlafaxine Tablets, USP 50 mg*, 100 Tablets Manufactured for Northstar Rx LLC Memphis, TN 38141 Manufactured by: ALKALOIDA Chemical Company Zrt. 4440 Tiszavasvari, Kabay Janos u.29.Hungary. Product of India NDC 16714-657-01
Where it was distributed
Northstar Distribution Center 4853 Crumpler Rd. Memphis, TN 38141
Questions about this recall
Is Venlafaxine Tablets, USP 50 mg* recalled?
Yes. Sun Pharmaceutical Industries recalled Venlafaxine Tablets, USP 50 mg* on 29 Jul 2021. The recall is Class II and its status is Terminated. Recall number D-0703-2021.
Why was it recalled?
Presence of Forein Tablets/Capsules; Venlafaxine Tablets, USP 37.5 mg found in bottles labeled as Venlafaxine Tablets, USP, 50 mg
Which lots are affected?
AVK1175A, exp 9/2023
Where was it sold?
Northstar Distribution Center 4853 Crumpler Rd. Memphis, TN 38141
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Venlafaxine recalls
All 19| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Venlafaxine Tablets, USP, 75 mg recalled by Zydus Pharmaceuticals (USA)Venlafaxine | Zydus Pharmaceuticals (USA) | Foreign Material | Nationwide |
| Drug | CLASS III | Venlafaxine Extended-Release Tablets, 150mg recalled by Appco PharmaVenlafaxine | Appco Pharma | Other | Nationwide |
| Drug | CLASS II | Venlafaxine Hydrochloride Extended-Release Capsules, USP 5mg recalledVenlafaxine Hydrochloride | Zydus Pharmaceuticals (USA) | Potency & Assay | Nationwide |
| Drug | CLASS II | Venlafaxine Hydrochloride Extended-Release Capsules USP, 75 mg recalled | Lucid Pharma | Packaging Defects | Nationwide |
| Drug | CLASS II | Venlafaxine Hydrochloride extended release capsules, 5 mg recalledVenlafaxine Hydrochloride | Aurobindo Pharma USA | Other | Nationwide |