Lupin Recalls Memantine Hydrochloride Capsules for Dissolution Failure
Lupin Pharmaceuticals is recalling 6,294 bottles of Memantine Hydrochloride Extended Release Capsules because they failed to meet dissolution specifications during stability testing.
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 recall is classified as FDA Class II, which is typically associated with a temporary or medically reversible adverse health consequence. The hazard is a failure to meet dissolution specifications, which is a quality control issue rather than a direct contamination or acute safety hazard like a structural defect or high-risk pathogen.
Plain-English summary
Lupin Pharmaceuticals Inc. is recalling 6,294 bottles of Memantine Hydrochloride Extended Release Capsules, 21 mg, 30-count bottles. The affected product is identified by Lot # H900330 with an expiration date of 11/2020. The product was distributed nationwide within the United States.
The recall was initiated because low out-of-specification results were observed in dissolution testing during a six-month long-term stability study. This indicates that the medication may not dissolve at the required rate, which could affect how the drug is absorbed by the body.
Patients and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product is found, it should be returned to the pharmacy or Lupin Pharmaceuticals for a refund or replacement. Consumers should not take the recalled medication and should consult their healthcare provider for alternative treatment options.
The recalled product
- Product
- MEMANTINE HYDROCHLORIDE (MEMANTINE HYDROCHLORIDE)
- Brand
- MEMANTINE HYDROCHLORIDE
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 6,294
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 #: H900330
- exp. date 11/2020.
UPCs (3)
- 0368180247067
- 0368180249061
- 0368180246060
Distribution
Distributed nationwide across the United States.
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