CLASS II Drug recall · Reported 23 May 2018 · FDA Enforcement Report

Scopolamine Transdermal Therapeutic System, 1 mg/3 days, a) recalled

L. Perrigo is recalling Scopolamine Transdermal Therapeutic System, 1 mg/3 days, a) (, distributed nationwide in the US. The recall was initiated on 11 May 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: a) 46397, 46457 Exp 03/19; 46621, Exp 04/19; 46894, 46904, 46905, Exp 06/19; 47133, Exp 07/19; 47153, Exp 08/19; 47154, 47213, 47214, Exp 09/19; b) 46695, Exp 04/19; 46994, 47012, Exp 07/19; 47322 10/19; c) 46822, Exp 05/19 ; 47155, 47212, Exp 09/19

NDC45802-580

Quantity recalled569,520 cartons

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0816-2018
FDA event ID: 80041
Recalling firm: L. Perrigo, Allegan, MI
Brand: Scopolamine Transdermal System
Manufacturer: Padagis Israel Pharmaceuticals Ltd
Classification: Class II
Status: Terminated
Recall initiated: 11 May 2018
FDA classified: 15 May 2018
Reported: 23 May 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons

Timeline

11 May 2018	Recall initiated by company
15 May 2018	Classified by FDA	+4 days
23 May 2018	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Defective delivery system

Product as listed by the FDA

Scopolamine Transdermal Therapeutic System, 1 mg/3 days, a) 4-count (NDC 45802-580-84); b) 10-count (NDC 45802-580-46); c) 24-count (NDC 45802-580-62), Rx only, Mfd. by: Aveva Drug Delivery Systems, A Nitto Denko Company, Miramar, FL 33025 Distributed by Perrigo, Allegan, MI 49010

Where it was distributed

Nationwide in the U.S.A.

Nationwide

Questions about this recall

Why was it recalled?

Defective delivery system

Which lots are affected?

Lot #: a) 46397, 46457 Exp 03/19; 46621, Exp 04/19; 46894, 46904, 46905, Exp 06/19; 47133, Exp 07/19; 47153, Exp 08/19; 47154, 47213, 47214, Exp 09/19; b) 46695, Exp 04/19; 46994, 47012, Exp 07/19; 47322 10/19; c) 46822, Exp 05/19 ; 47155, 47212, Exp 09/19

Where was it sold?

Nationwide in the U.S.A.

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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