CLASS III Drug recall · Reported 19 Jun 2013 · FDA Enforcement Report
Fentanyl Transdermal System, 50 mcg/h, 1 system per pouch recalled
Actavis is recalling Fentanyl Transdermal System, 50 mcg/h, 1 system per pouch (, distributed nationwide in the US. The recall was initiated on 3 Jun 2013 and the FDA has classified it as Class III.
Check your package
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-599-2013
- FDA event ID
- 65334
- Recalling firm
- Actavis, Salt Lake City, UT
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 3 Jun 2013
- FDA classified
- 12 Jun 2013
- Reported
- 19 Jun 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 3 Jun 2013 | Recall initiated by company | |
| 12 Jun 2013 | Classified by FDA | +9 days |
| 19 Jun 2013 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Fentanyl Transdermal System, 50 mcg/h, 1 system per pouch (NDC 0591-3212-54), packaged in 5-count systems per box (NDC 0591-3212-72), Rx only, Manufactured by Watson Laboratories, Inc, Corona, CA, 92880 USA; Distributed by: Watson Pharma, Inc.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications
Which lots are affected?
Lot #: Patch 453658; Carton 453658A, Exp 09/13
Where was it sold?
Nationwide
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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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Other Fentanyl Transdermal System recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Fentanyl Transdermal System, 50 mcg/h recalled by Teva Pharmaceuticals U | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS III | Fentanyl Transdermal System, 100 mcg/h recalled | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Fentanyl Transdermal System, 100 mcg/h recalled by Actavis | Actavis | Potency & Assay | Nationwide |