CLASS II Drug recall · Reported 22 Feb 2017 · FDA Enforcement Report
Venlafaxine Hydrochloride extended release capsules, 5 mg recalled
Aurobindo Pharma USA is recalling Venlafaxine Hydrochloride extended release capsules, 5 mg, distributed nationwide in the US. The recall was initiated on 22 Dec 2016 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-0474-2017
- FDA event ID
- 76325
- Recalling firm
- Aurobindo Pharma USA, Plainsboro, NJ
- Manufacturer
- Aurobindo Pharma Limited
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Dec 2016
- FDA classified
- 13 Feb 2017
- Reported
- 22 Feb 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Antidepressants
Timeline
| 22 Dec 2016 | Recall initiated by company | |
| 13 Feb 2017 | Classified by FDA | +53 days |
| 22 Feb 2017 | Published in enforcement report | +9 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: Some bottles contain punctured, and/or clumped/melted capsules.
Product as listed by the FDA
Venlafaxine Hydrochloride extended release capsules, 37.5 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc. 2400 Route 130 North, Dayton, NJ 08810 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 072 India, NDC 65862-527-30
Where it was distributed
Nationwide in the US
Questions about this recall
Is Venlafaxine Hydrochloride extended release capsules, 5 mg recalled?
Yes. Aurobindo Pharma USA recalled Venlafaxine Hydrochloride extended release capsules, 5 mg on 22 Dec 2016. The recall is Class II and its status is Terminated. Recall number D-0474-2017.
Why was it recalled?
Failed Tablet/Capsule Specifications: Some bottles contain punctured, and/or clumped/melted capsules.
Which lots are affected?
Lot #: VI3716010-A, Exp. 04/2018
Where was it sold?
Nationwide in the US
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.
More recalls from Aurobindo Pharma USA
All 58| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Dicyclomine Hydrochloride Capsules, USP, 10mg recalledDicyclomine Hydrochloride | Aurobindo Pharma USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Acetaminophen Tablets, 325 mg recalled by Aurobindo Pharma USAAmazon Basic Care Acetaminophen | Aurobindo Pharma USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Nebivolol Tablets recalled by Aurobindo Pharma USANebivolol | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Tablets, 90 mg recalled by Aurobindo Pharma USA | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Tablets, 30 mg recalled by Aurobindo Pharma USA | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |
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 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 |