Jubilant Cadista Recalls Meclizine Hydrochloride Tablets Marketed Without Approval
Jubilant Cadista Pharmaceuticals is recalling 744 bottles of Meclizine Hydrochloride 12.5 mg tablets because they were released prior to final approval.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which is defined as a situation where use of or exposure to a violative product is not likely to cause adverse health consequences. The issue is a regulatory documentation/approval failure rather than a direct physical hazard.
Plain-English summary
Jubilant Cadista Pharmaceuticals, Inc. is recalling 744 bottles of Meclizine Hydrochloride tablets USP, 12.5 mg, 100 count. The affected product is identified by Lot # 17P0430 and an expiration date of 05/19. The bottles were distributed nationwide.
The recall was initiated because the bottles were released prior to final approval of the New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). This constitutes a regulatory violation where the product was marketed without the required approval.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance. The product is prescription-only, so patients should consult their prescriber regarding alternative treatments.
The recalled product
- Product
- MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE)
- Brand
- MECLIZINE HYDROCHLORIDE
- Manufacturer
- Jubilant Cadista Pharmaceuticals, Inc.
- Category
- Drug — Prescription Drug
- Affected units
- 744
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 (2)
- Lot # 17P0430
- Exp 05/19
UPCs (2)
- 0359746121068
- 0359746122065
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · MECLIZINE HYDROCHLORIDE
- HighMeclizine hydrochloride 12.5 mg tablets recalled after failing tablet specifications
FDA (Drugs) · 2026-04-01
- HighMeclizine Hydrochloride Tablets Recalled for Manufacturing Temperature Control Deviations
FDA (Drugs) · 2022-06-15
- SevereMeclizine Hydrochloride Tablets Recalled Due to Incorrect Label Mix-up
FDA (Drugs) · 2022-04-06
Same manufacturer · Jubilant Cadista Pharmaceuticals, Inc.
See all →- Moderate
- HighJubilant Cadista Irbesartan tablets recalled due to failed dissolution
FDA (Drugs) · 2022-08-03
- HighIrbesartan Blood Pressure Tablets Recalled Due to Failed Dissolution
FDA (Drugs) · 2022-08-03
- ModerateFDA Voluntary Recall of Methylprednisolone Tablets for Subpotency
FDA (Drugs) · 2022-04-13
- LowDonepezil HCL Tablets 5 mg Recalled for Subpotency
FDA (Drugs) · 2021-09-08
Same hazard · regulatory non compliance
See all →- ModerateLimitless Cryo Spa LLC Recalls Glypto Devices for Lack of 510(k) Clearance
FDA (Devices) · 2026-10-14
- SevereSempio Recalls Ready-to-Eat Chicken Stew Imported Without Reinspection
USDA FSIS · 2026-09-25
- ModerateMedline Polycarbonate Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01
- SevereMedline polycarbonate syringes recalled for unapproved design changes
FDA (Devices) · 2026-07-01
- ModerateMedline 10mL Polycarbonate Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01
Similar recalls
- SevereMeclizine Hydrochloride Tablets Recalled Due to Incorrect Label Mix-up
FDA (Drugs) · 2022-04-06
- ModerateJubilant Cadista Recalls Clomipramine Hydrochloride Capsules Due to Specification Failure
FDA (Drugs) · 2020-12-02
- ModerateJubilant Cadista Recalls Bupropion Hydrochloride Tablets Due to Impurities
FDA (Drugs) · 2017-04-19
- LowJubilant Cadista Recalls Methylprednisolone Tablets Due to Incorrect Expiration Date Labeling
FDA (Drugs) · 2016-12-21
- LowJubilant Cadista Recalls Methylprednisolone Tablets Due to Illegible Labeling
FDA (Drugs) · 2021-03-10
- ModeratePar Pharmaceutical Recalls Meclizine Hydrochloride Tablets Due to Impurity Failures
FDA (Drugs) · 2015-11-25