Prochlorperazine Maleate tablets recalled for subpotency: out of specification at stability testing
Jubilant Cadista Pharmaceuticals recalls 14,061 bottles of Prochlorperazine Maleate 5mg tablets nationwide due to subpotency. The medication failed quality testing at 18 months and contains less active ingredient than specified.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III recall with no reported illnesses or injuries. The hazard is subpotency—reduced active ingredient—which represents a manufacturing quality defect rather than an acute safety threat. Class III recalls are typically scored 1–2.
Plain-English summary
Jubilant Cadista Pharmaceuticals, Inc. is recalling 14,061 bottles of Prochlorperazine Maleate Tablets, USP 5mg, nationwide. The recall affects Lot 21P0336, expiration 04/2023. The medication failed quality testing at the 18-month stability timepoint: the assay—the measure of active ingredient strength—was found to be out of specification, meaning the drug contains less active ingredient than required.
Prochlorperazine Maleate is a prescription medication. Consumers with this medication should contact their pharmacist or healthcare provider to discuss next steps. Do not discontinue use without consulting your provider. Return the recalled medication to your pharmacy for safe disposal or replacement.
The recalled product
- Product
- PROCHLORPERAZINE MALEATE (PROCHLORPERAZINE MALEATE)
- Brand
- PROCHLORPERAZINE MALEATE
- Manufacturer
- Jubilant Cadista Pharmaceuticals, Inc.
- Category
- Drug
- Hazard
- subpotency
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#: 21P0336
- Exp: 04/2023
UPCs (2)
- 0359746113063
- 0359746115067
Distribution
Distributed nationwide across the United States.
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