D-0876-2018 Class III Terminated
FDA drug recall D-0876-2018 was initiated by Jubilant Cadista Pharmaceuticals, Inc. on May 25, 2018 and is designated Class III. Reason for recall: Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a larger size grade of excipient (Crospovidone). The recall status is terminated (terminated Jan 8, 2020). Affected quantity: 2,328 bottles (Lot VR417065A) and 2,352 bottles (Lot VR417066A).
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 13, 2018
- Initiation Date
- May 25, 2018
- Termination Date
- Jan 8, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,328 bottles (Lot VR417065A) and 2,352 bottles (Lot VR417066A)
Product Description
Valsartan Tablets USP, 320 mg, 90 tablet, Rx Only, Manufactured by: Jubilant Generics Ltd. Roorkee - 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-363-90
Reason for Recall
Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a larger size grade of excipient (Crospovidone).
Distribution Pattern
IN, MI, MS, NC, NJ, NY and OH
Code Information
Lot #: VR417065A, VR417066A, Exp 10/2019
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0876-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026