PlainRecalls
ModerateClass IITerminated

FDA Drug recall · Reported November 16, 2016

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

Defective Delivery System; reports of damaged product that may alter the predicted release of scopolamine following transdermal application.

Recall #
D-0133-2017
Affected scope
42,740 cartons (24 count carton from 7 total lots)
Initiated
August 24, 2016
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Sandoz Inc recalled Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 24 patches Multi pack, Rx only, … - a moderate-severity action.

Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 24 patches Multi pack, Rx only, … was recalled by Sandoz Inc in November 16, 2016. Reason: Defective Delivery System; reports of damaged product that may alter the predicted release of scopolamine fol…. Check the official notice for the remedy. Verify recall #D-0133-2017 with the FDA Drug before acting.

The recall

Sandoz Inc issued this moderate-severity FDA Drug recall-Defective Delivery System; reports of damaged product that may alter the predicted release of scopolamine fol….

Moderate
severity level
Class II
classification
November 16, 2016
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-0133-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Drugs & Medications recalls over time

Where this recall sits in its category - 14,472 drugs & medications recalls on record

05001,0001,5002,000 2006201220152018202120242026 448
Severity1906864652High severity (most serious)Moderate severityLow severity
Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

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

Reason for recall

Defective Delivery System; reports of damaged product that may alter the predicted release of scopolamine following transdermal application.

Recall Profile

Structured summary of the FDA Drug recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Terminated
Recall number D-0133-2017
Date reported November 16, 2016
Date initiated August 24, 2016
Recalling firm Sandoz Inc
Firm location Princeton, NJ
Affected scope 42,740 cartons (24 count carton from 7 total lots)
Distribution TN

Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (D-0133-2017) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Drug before acting, recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled?
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. Recalled by Sandoz Inc. Units affected: 42,740 cartons (24 count carton from 7 total lots).
Why was this product recalled?
Defective Delivery System; reports of damaged product that may alter the predicted release of scopolamine following transdermal application.
Which agency issued this recall?
This recall was issued by the FDA Drug on November 16, 2016. Severity: Moderate. Recall number: D-0133-2017.
Where was the recalled product distributed?
Distribution: TN.
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Compare this recall with Kian Pee Wan Capsules, 30-count bottles → · All Drugs & Medications recalls

This recall: FDA Drug, reported November 16, 2016. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026