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.
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: 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.
Related recalls
Same manufacturer · Lupin Pharmaceuticals Inc.
See all →- ModerateLupin Recalls Clobetasol Propionate Cream for Content Uniformity Failures
FDA (Drugs) · 2026-09-02
- SevereGlucagon Emergency Kit Recalled for Manufacturing Process Deviation
FDA (Drugs) · 2026-07-08
- HighPrednisolone Acetate Ophthalmic Suspension Recalled for Foreign Substance
FDA (Drugs) · 2026-07-08
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- ModerateGanirelix acetate injection recalled after failing an impurity specification
FDA (Drugs) · 2025-12-17
Same hazard · dissolution failure
See all →- ModerateMylan Recalls Mycophenolate Mofetil Injection Due to Dissolution Failures
FDA (Drugs) · 2026-09-09
- ModerateApotex Recalls Paxil Tablets for Failed Dissolution and Stability Testing
FDA (Drugs) · 2026-09-02
- ModerateMylan Recalls Acamprosate Calcium Tablets Due to Dissolution Failure
FDA (Drugs) · 2026-08-26
- ModerateChlorthalidone 25mg tablets failed dissolution specifications in two batches
FDA (Drugs) · 2026-06-24
- ModerateNiacin extended-release tablets failed dissolution testing at 24 hours
FDA (Drugs) · 2026-06-17