Reported Feb 19, 2020 · Terminated

Memantine Hydrochloride Extended Release Capsules, 21 mg, 30-count bottles, Rx Only, Manufactured for: Lupin…

Lupin Pharmaceuticals Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Lupin Pharmaceuticals Inc. · Harborplace Tower · Baltimore, MD · 21202-6174

Is this the product you have?

  • Memantine Hydrochloride Extended Release Capsules, 21 mg, 30-count bottles, Rx Only
  • Manufactured forLupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States
  • Manufactured by
    • Lupin Limited Pithampur (M.P.)-454 775
    • INDIA
    • NDC 68180-248-06
Lot codes and dates
    • Lot #: H900330
    • exp. date 11/2020
Amount recalled
6,294 bottles

Where it was sold

  • Nationwide

Why it was recalled

Failed Dissolution Specifications: Low out of specification results observed in dissolution test at six-month long-term stability study.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jun 3, 2021 · Data as of Sep 19, 5:03 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.