Transderm Scop (Sandoz) – Defective Delivery System (2016)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 24 patches Multi pack, Rx only, Marketed by Baxter Healthcare Cop/Novartis, Deerfield, IL 60015, Manufactured by:Alza Corporation, Vacaville, CA 95688 for Novartis Consumer Health Inc., Parsippany, NJ 07054
Brand
Sandoz Inc
Lot Codes / Batch Numbers
NDC 10019-553-02 (24 ct. carton) and NDC 10019-553-88 (patch), Lot #'s FV5908 and FX1520 both with expiry 06/2018, GB4910 and GC4210 both with expiry 09/2018, GE1927 with expiry 12/2018, GF7017 with expiry 01/2019 and GH8065 with expiry 02/2019.
Products Sold
NDC 10019-553-02 (24 ct. carton) and NDC 10019-553-88 (patch); Lot #'s FV5908 and FX1520 both with expiry 06/2018; GB4910 and GC4210 both with expiry 09/2018; GE1927 with expiry 12/2018; GF7017 with expiry 01/2019 and GH8065 with expiry 02/2019.
Sandoz Inc is recalling Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 24 patches Multi pack, Rx only, Marketed by due to Defective Delivery System; reports of damaged product that may alter the predicted release of scopolamine following transdermal application.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Defective Delivery System; reports of damaged product that may alter the predicted release of scopolamine following transdermal application.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
TN
Page updated: Jan 7, 2026