Lupin Recalls Memantine Hydrochloride Capsules Due to Dissolution Failure
Lupin Pharmaceuticals is recalling 3,726 bottles of Memantine Hydrochloride Extended-release Capsules because stability studies showed high out-of-specification dissolution results.
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 FDA classified this as a Class III recall, which is defined as unlikely to cause adverse health consequences. The issue is a quality control failure (dissolution) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Lupin Pharmaceuticals Inc. is recalling 3,726 bottles of Memantine Hydrochloride Extended-release Capsules, 28mg. The affected products are packaged in 90-count bottles (NDC 68180-249-09) and 500-count bottles (NDC 68180-249-02). The specific lots involved are H901787 and H901788, with an expiration date of March 2021.
The recall was initiated because high out-of-specification results were observed during stability studies regarding the dissolution of the capsules. This indicates that the medication may not dissolve at the required rate, potentially affecting its performance.
The affected products were distributed nationwide in the USA. Consumers and healthcare providers should check their inventory for these specific lot numbers and NDC codes. If found, the medication should be discontinued and returned to the pharmacy or Lupin Pharmaceuticals for disposal or credit.
The recalled product
- Product
- MEMANTINE HYDROCHLORIDE (MEMANTINE HYDROCHLORIDE)
- Brand
- MEMANTINE HYDROCHLORIDE
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 3,726
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 (3)
- Lot #: H901787
- H901788
- Exp March 2021
UPCs (3)
- 0368180247067
- 0368180249061
- 0368180246060
Distribution
Distributed nationwide across the United States.
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