Jubilant Cadista Recalls Valsartan Tablets Due to Incorrect Excipient Size
Jubilant Cadista Pharmaceuticals is recalling specific lots of Valsartan 320 mg tablets because they were released with an incorrect size grade of the excipient Crospovidone.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Jubilant Cadista Pharmaceuticals, Inc. is recalling Valsartan Tablets USP, 320 mg, 90 tablet bottles. The recall involves 2,328 bottles from Lot VR417065A and 2,352 bottles from Lot VR417066A, both with an expiration date of 10/2019. The product is marketed under NDC 59746-363-90 and was manufactured by Jubilant Generics Ltd. in India.
The recall was initiated because the product batches were released into commercial distribution with a larger size grade of the excipient Crospovidone than intended. This is classified as an FDA Class III recall, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
The affected product was distributed in Indiana, Michigan, Mississippi, North Carolina, New Jersey, New York, and Ohio. Patients should consult their healthcare provider or pharmacist for guidance on alternative medications or further instructions regarding the recalled product.
The recalled product
- Product
- VALSARTAN (VALSARTAN)
- Brand
- VALSARTAN
- Manufacturer
- Jubilant Cadista Pharmaceuticals, Inc.
- Category
- Drug — Prescription Drug
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #: VR417065A
- VR417066A
- Exp 10/2019
UPCs (8)
- 0359746363321
- 0359746363307
- 0359746361037
- 0359746362034
- 0359746360306
- 0359746360030
- 0359746361303
- 0359746362300
Distribution
Related recalls
Same brand · VALSARTAN
- ModerateCardinal Health Recalls Valsartan Tablets Due to Temperature Excursions
FDA (Drugs) · 2021-06-02
- SevereAurobindo Pharma Recalls Valsartan Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-03-27
- SevereAurobindo Recalls Valsartan Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-03-27
- SevereAurobindo Pharma Recalls Valsartan Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-03-27
- SevereAurobindo Recalls Valsartan Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-03-27
Same manufacturer · Jubilant Cadista Pharmaceuticals, Inc.
See all →- Moderate
- HighIrbesartan Blood Pressure Tablets Recalled Due to Failed Dissolution
FDA (Drugs) · 2022-08-03
- HighJubilant Cadista Irbesartan tablets recalled due to failed dissolution
FDA (Drugs) · 2022-08-03
- ModerateFDA Voluntary Recall of Methylprednisolone Tablets for Subpotency
FDA (Drugs) · 2022-04-13
- SevereMeclizine Hydrochloride Tablets Recalled Due to Incorrect Label Mix-up
FDA (Drugs) · 2022-04-06
Same hazard · incorrect excipient
See all →- ModerateTadalafil Tablets Recalled for Incorrect Product Formulation
FDA (Drugs) · 2021-11-17
- ModerateQuVa Pharma Recalls Norepinephrine Injection Bags Due to Incorrect Excipient
FDA (Drugs) · 2018-12-19
- LowJubilant Cadista Recalls Valsartan Tablets Due to Potential Excipient Error
FDA (Drugs) · 2018-08-29
- LowJubilant Cadista Recalls Valsartan Tablets Due to Incorrect Excipient Grade
FDA (Drugs) · 2018-08-29
- ModerateJubilant Cadista Recalls Valsartan Tablets Due to Incorrect Excipient Grade
FDA (Drugs) · 2018-08-29