Jubilant Cadista Recalls Clomipramine Hydrochloride Capsules Due to Specification Failure
Jubilant Cadista Pharmaceuticals is recalling 4,416 bottles of clomipramine hydrochloride capsules because they failed tablet/capsule specifications.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
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: The recall is classified as FDA Class II. The source text does not report any illnesses, injuries, or hospitalizations, and the hazard is a specification failure without explicit mention of high-risk pathogens or structural defects, fitting the criteria for a moderate severity score.
Plain-English summary
Jubilant Cadista Pharmaceuticals, Inc. is recalling 4,416 bottles of clomipramine hydrochloride capsules USP, 50 mg, 30-count bottles. The recall is due to a failure in tablet/capsule specifications. The affected product is identified by Lot# 20P0141 and an expiration date of 02/2022.
The product was distributed nationwide. The recall is classified as Class II by the U.S. Food and Drug Administration.
Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- Product
- clomiPRAMINE Hydrochloride Capsules USP, 50 mg, 30-count bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD NDC 59746-711-30
- Manufacturer
- Jubilant Cadista Pharmaceuticals, Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 4,416
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# 20P0141
- exp. date 02/2022
Distribution
Distributed nationwide across the United States.
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