CLASS II Drug recall · Reported 3 Oct 2012 · FDA Enforcement Report
Fentanyl Transdermal System, 100 mcg/h recalled by Actavis
Actavis is recalling Fentanyl Transdermal System, 100 mcg/h, each transdermal system contains: 10 mg fentanyl, distributed nationwide in the US. The recall was initiated on 11 Jul 2012 and the FDA has classified it as Class II.
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-1693-2012
- FDA event ID
- 62384
- Recalling firm
- Actavis, Salt Lake City, UT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Jul 2012
- FDA classified
- 25 Sep 2012
- Reported
- 3 Oct 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 11 Jul 2012 | Recall initiated by company | |
| 25 Sep 2012 | Classified by FDA | +76 days |
| 3 Oct 2012 | 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
Subpotent; some patches may not contain fentanyl gel
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, 100 mcg/h, each transdermal system contains: 10 mg fentanyl and 0.4 mL alcohol USP, Rx only, supplied in single pouches (NDC 0591-3214-54 (pouch)), 5 pouches per carton (NDC 0591-3214-72 (Carton)), Manufactured by Watson laboratories Inc., Corona, CA, Distributed by: Watson, Pharma Inc.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Subpotent; some patches may not contain fentanyl gel
Which lots are affected?
Lot number 455040A (carton) 455040 (pouch)
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 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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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 III | Fentanyl Transdermal System, 50 mcg/h, 1 system per pouch recalled | Actavis | Potency & Assay | Nationwide |