Lupin Imipramine Pamoate Capsules Recalled for Failed Dissolution Test
Lupin Pharmaceuticals is recalling approximately 1,902 bottles of Imipramine Pamoate Capsules 125 mg due to out-of-specification results in dissolution testing at the 9-month stability checkpoint.
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 FDA classified this as a Class II recall. The source text reports no hospitalizations, illnesses, or injuries—only an out-of-specification test result detected during stability testing. The hazard is theoretical (potential loss of therapeutic effect) rather than an acute safety threat. This fits the rubric criterion for Moderate severity: "Minor labeling errors, low-risk contamination, voluntary precautionary recalls."
Plain-English summary
Lupin Pharmaceuticals Inc. is recalling Imipramine Pamoate Capsules 125 mg (30-count bottles, lot H002205, expiration date 08/2023, NDC# 68180-316-06) that were distributed nationwide in the USA. The recall was initiated because dissolution test results at the 9-month long-term stability timepoint fell out of specification.
Imipramine Pamoate is a tricyclic antidepressant medication prescribed to treat depression. When a drug fails dissolution testing, it may not release and absorb properly in the body, potentially affecting the medication's therapeutic effectiveness.
Affected product was distributed nationwide. Consumers currently taking this medication should contact their pharmacy or healthcare provider for guidance before discontinuing use. Healthcare providers should consider testing patient stability if they are on this recalled lot.
The recalled product
- Product
- IMIPRAMINE PAMOATE (IMIPRAMINE PAMOATE)
- Brand
- IMIPRAMINE PAMOATE
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Affected units
- 1,902
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 H002205
- exp. date 08/2023
UPCs (3)
- 0368180314066
- 0368180316060
- 0368180315063
Distribution
Distributed nationwide across the United States.
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