Lupin Recalls Duloxetine Capsules Due to Failed Dissolution Specification
Lupin Pharmaceuticals is recalling 111,648 bottles of Duloxetine 30 mg capsules because they failed to meet dissolution standards.
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 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 III, which indicates the product is not likely to cause adverse health consequences. The failure to meet dissolution specifications is a quality control issue that may affect drug efficacy but does not present an immediate safety hazard like contamination or mislabeling of allergens.
Plain-English summary
Lupin Pharmaceuticals, Inc. is recalling 111,648 units of Duloxetine Delayed-Release Capsules USP, 30 mg, 30-count bottles. The product is identified by Lot # G602051 and an expiration date of 12/2017. The recall was initiated because the product failed to meet dissolution specifications.
The affected medication is a prescription-only oral drug manufactured for Lupin Pharmaceuticals, Inc. in Baltimore, Maryland, and manufactured by Lupin Limited in Goa, India. The product was distributed nationwide within the United States.
Consumers who have this specific lot of Duloxetine should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement or alternative treatment.
The recalled product
- Product
- DULOXETINE (DULOXETINE)
- Brand
- DULOXETINE
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 111,648
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 #: G602051
- Exp. 12/2017
UPCs (3)
- 0368180294030
- 0368180296034
- 368180295068
Distribution
Distributed nationwide across the United States.
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