Food, drugs, devices › Zydus Pharmaceuticals USA Inc
Drug recall: risperiDONE ORALLY DISINTEGRATING TABLETS, 2 mg, 30 Ct Bottles, Rx Only. Manufactured by: Cadila Healthcare Ltd., Ahmeda
Zydus Pharmaceuticals USA Inc (Pennington, NJ) initiated this drug recall on 14 Jan 2016; FDA lists 1 product record under event 73221, classified Class III.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 43% of the 288 drug enforcement events initiated in 2016 carry the same class.
Status: Terminated, terminated 18 Dec 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
"Failed Impurities/Degradation Specifications: Out of specification for a known degradant."
Distribution
"US Nationwide including Puerto Rico"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0725-2016 | risperiDONE ORALLY DISINTEGRATING TABLETS, 2 mg, 30 Ct Bottles, Rx Only. Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India. Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC: 68382-156-06. | 9504 Bottles | Class III | Terminated | 2 Mar 2016 |
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: "Failed Impurities/Degradation Specifications: Out of specification for a known degradant."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide including Puerto Rico"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 18 Dec 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.