CLASS II Drug recall · Reported 3 Apr 2013 · FDA Enforcement Report
Venlafaxine Hydrochloride Tablets, 75 mg* tablets recalled
Zydus Pharmaceuticals USA is recalling Venlafaxine Hydrochloride Tablets, 75 mg* tablets per, distributed nationwide in the US. The recall was initiated on 5 Mar 2013 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-202-2013
- FDA event ID
- 64604
- Recalling firm
- Zydus Pharmaceuticals USA, Pennington, NJ
- Brand
- Venlafaxine
- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Mar 2013
- FDA classified
- 25 Mar 2013
- Reported
- 3 Apr 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Antidepressants
Timeline
| 5 Mar 2013 | Recall initiated by company | |
| 25 Mar 2013 | Classified by FDA | +20 days |
| 3 Apr 2013 | 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: Pharmacist complaint of an excessive amount of broken and/or chipped tablets in the bottle.
Product as listed by the FDA
Venlafaxine Hydrochloride Tablets, 75 mg*, 100-count tablets per bottle, Rx only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India; Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-021-01.
Where it was distributed
Nationwide.
Questions about this recall
Is Venlafaxine Hydrochloride Tablets, 75 mg* tablets per recalled?
Yes. Zydus Pharmaceuticals USA recalled Venlafaxine Hydrochloride Tablets, 75 mg* tablets per on 5 Mar 2013. The recall is Class II and its status is Terminated. Recall number D-202-2013.
Why was it recalled?
Failed Tablet/Capsule Specifications: Pharmacist complaint of an excessive amount of broken and/or chipped tablets in the bottle.
Which lots are affected?
Lot #: MM8490, Exp 09/14
Where was it sold?
Nationwide.
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 Zydus Pharmaceuticals USA
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|---|---|---|---|---|---|
| Drug | CLASS II | Mirabegron Extended-Release Tablets, 25 mg recalledMirabegron | Zydus Pharmaceuticals (USA) | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Erythromycin Tablets, USP, 250 mg recalledErythromycin | Zydus Pharmaceuticals (USA) | Nitrosamine Impurity | Nationwide |
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| Drug | CLASS II | Icosapent Ethyl Capsules recalled by Zydus Pharmaceuticals (USA)Icosapent Ethyl | Zydus Pharmaceuticals (USA) | Other | Nationwide |
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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 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 |