Food, drugs, devices › Zydus Pharmaceuticals USA Inc
Drug recall: Paroxetine tablets USP, 30mg, 30-count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India Distri
FDA enforcement event 77963 is a drug recall by Zydus Pharmaceuticals USA Inc of Pennington, NJ, initiated 18 Aug 2017 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 57% of the 343 drug enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 6 Jan 2020. Initiation: voluntary: firm initiated. Zydus Pharmaceuticals USA Inc has 54 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Zydus Pharmaceuticals USA Inc, Pennington, NJ.
Reason for recall
"Presence of Foreign tablets/capsules: risperidone Tablets were found in bottle of paroxetine Tablets"
Distribution
"Nationwide within United States"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1137-2017 | 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 | 44800 bottles | Class II | Terminated | 20 Sep 2017 |
Context
Other enforcement events for Zydus Pharmaceuticals USA Inc
All 54 events for Zydus Pharmaceuticals USA Inc
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Presence of Foreign tablets/capsules: risperidone Tablets were found in bottle of paroxetine Tablets"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide within United States"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 6 Jan 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.