CLASS II Drug recall · Reported 20 Sep 2017 · FDA Enforcement Report
Paroxetine tablets USP, 30mg recalled by Zydus Pharmaceuticals USA
Zydus Pharmaceuticals USA is recalling Paroxetine tablets USP, 30mg, distributed nationwide in the US. The recall was initiated on 18 Aug 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-1137-2017
- FDA event ID
- 77963
- Recalling firm
- Zydus Pharmaceuticals USA, Pennington, NJ
- Brand
- Paroxetine
- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Aug 2017
- FDA classified
- 11 Sep 2017
- Reported
- 20 Sep 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Antidepressants
Timeline
| 18 Aug 2017 | Recall initiated by company | |
| 11 Sep 2017 | Classified by FDA | +24 days |
| 20 Sep 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
Presence of Foreign tablets/capsules: risperidone Tablets were found in bottle of paroxetine Tablets
Product as listed by the FDA
Paroxetine tablets USP, 30mg, 30-count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA, Inc., Pennington, NJ 08534, NDC 68382-099-06, UPC 3 6838209906 8
Where it was distributed
Nationwide within United States
Questions about this recall
Why was it recalled?
Presence of Foreign tablets/capsules: risperidone Tablets were found in bottle of paroxetine Tablets
Which lots are affected?
Lot #: Z701133, Exp 03/19
Where was it sold?
Nationwide within United States
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 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 Zydus Pharmaceuticals USA
All 41| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ethacrynate Sodium for Injection, USP, 50mg/vial, Single Dose Vial recalled | Zydus Pharmaceuticals USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Pramipexole Dihydrochloride Tablets 1 mg recalled | Zydus Pharmaceuticals USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | MethylPREDNISolone Tablets, USP 32 mg recalledMethylprednisolone | Zydus Pharmaceuticals USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Pramipexole Dihydrochloride Tablets 0.25 mg recalled | Zydus Pharmaceuticals USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Pramipexole Dihydrochloride Tablets 0.125 mg recalled | Zydus Pharmaceuticals USA | Manufacturing (CGMP) Deviations | Nationwide |
Other Paroxetine recalls
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Paroxetine Extended-Release Tablets, 37.5mg recalled by ApotexParoxetine Hydrochloride | Apotex | Potency & Assay | Nationwide |
| Drug | CLASS II | Paroxetine Hydrochloride Tablets recalled by Apotex | Apotex | Potency & Assay | Nationwide |
| Drug | CLASS II | Paroxetine tablets, USP, 20 mg, Packaged as a) recalled | Golden State Medical Supply | Potency & Assay | Nationwide |
| Drug | CLASS II | Paroxetine Hydrochloride Tablets recalled by Apotex | Apotex | Potency & Assay | Nationwide |
| Drug | CLASS II | Paroxetine tablets, USP, 40 mg, Packaged as a) recalled | Golden State Medical Supply | Potency & Assay | Nationwide |