CLASS II Drug recall · Reported 6 Dec 2017 · FDA Enforcement Report
Paroxetine Tablets USP, 30 mg, a) recalled by Zydus Pharmaceuticals USA
Zydus Pharmaceuticals USA is recalling Paroxetine Tablets USP, 30 mg, a) (, distributed nationwide in the US. The recall was initiated on 20 Nov 2017 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-0101-2018
- FDA event ID
- 78612
- Recalling firm
- Zydus Pharmaceuticals USA, Pennington, NJ
- Brand
- Paroxetine
- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Nov 2017
- FDA classified
- 30 Nov 2017
- Reported
- 6 Dec 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Antidepressants
Timeline
| 20 Nov 2017 | Recall initiated by company | |
| 30 Nov 2017 | Classified by FDA | +10 days |
| 6 Dec 2017 | 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
Presence of Foreign Tablets/Capsules: Risperidone Tablets were found in bottle of Paroxetine Tablets
Product as listed by the FDA
Paroxetine Tablets USP, 30 mg, a) 30 count (NDC 68382-099-06), b) 500 count (NDC 68382-099-05), and c) 1000 count (NDC 68382-099-10) count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA, Inc., Pennington, NJ 08534
Where it was distributed
Nationwide
Questions about this recall
Is Paroxetine Tablets USP, 30 mg, a) ( recalled?
Yes. Zydus Pharmaceuticals USA recalled Paroxetine Tablets USP, 30 mg, a) ( on 20 Nov 2017. The recall is Class II and its status is Terminated. Recall number D-0101-2018.
Why was it recalled?
Presence of Foreign Tablets/Capsules: Risperidone Tablets were found in bottle of Paroxetine Tablets
Which lots are affected?
a) Z701308, b) Z701309, c) Z701310 exp April 2019
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
All 95| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |
| Drug | CLASS II | Erythromycin Tablets, USP, 500 mg recalledErythromycin | Zydus Pharmaceuticals (USA) | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Icosapent Ethyl Capsules recalled by Zydus Pharmaceuticals (USA)Icosapent Ethyl | Zydus Pharmaceuticals (USA) | Other | Nationwide |
| Drug | CLASS II | Icosapent Ethyl capsules recalled by Zydus Pharmaceuticals (USA) | Zydus Pharmaceuticals (USA) | Potency & Assay | Nationwide |
Other Paroxetine recalls
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Paroxetine Hydrochloride Tablets recalled by ApotexParoxetine | Apotex | Potency & Assay | Nationwide |
| Drug | CLASS II | Paroxetine tablets, USP, 20 mg, Packaged as a) recalledParoxetine | Golden State Medical Supply | Potency & Assay | Nationwide |
| Drug | CLASS II | Paroxetine Hydrochloride Tablets recalled by ApotexParoxetine | Apotex | Potency & Assay | Nationwide |
| Drug | CLASS II | Paroxetine tablets, USP, 40 mg, Packaged as a) recalledParoxetine | Golden State Medical Supply | Potency & Assay | Nationwide |
| Drug | CLASS II | Paroxetine Hydrochloride Tablets recalled by ApotexParoxetine | Apotex | Potency & Assay | Nationwide |