Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class II · Moderate risk Terminated Initiated Jan 26, 2022 (5 years ago)

Rivastigmine Transdermal System

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

Cause type: Temperature excursion

The product was stored or shipped outside its labeled temperature range. Heat or freezing can degrade a drug without any visible change, so it may be weaker than labeled. All temperature excursion recalls.

What was recalled

RIVASTIGMINE TRANSDERMAL SYSTEM, Delivers 4.6 mg/24 hours, 30 systems per box, Rx Only, Distributed by: Alvogen, Inc., Morristown, NJ 07960. NDC 47781-304-03

Affected NDC 47781-0304-03

Compare with the code on your package — it is the most precise check available.

Drug: Rivastigmine

Recalling firm
Cardinal Healthcare
NDC code
47781-304-03
Origin
OH, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0196-2024 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.

Other Rivastigmine recalls

See all
Class III · Low risk

RIVASTIGMINE Tartrate Capsules

Cross-contamination with other products -Related Substances test for Rivastigmine Tartrate Capsules USP, 1.5 mg showed a peak for Ranitidine.

Terminated Cross-contamination Dr. Reddy's Laboratories, Inc. NDC 55111-352-60 D-0649-2017

Other recalls by Cardinal Healthcare

All 2022 recalls
Class II · Moderate risk

Inhub Wixela

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

Terminated Temperature excursion Cardinal Healthcare D-0202-2024
Class II · Moderate risk

Warfarin Sodium Tablets

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

Terminated Temperature excursion Cardinal Healthcare D-0201-2024
Class II · Moderate risk

Warfarin Sodium Tablets

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

Terminated Temperature excursion Cardinal Healthcare D-0200-2024