CLASS II Drug recall · Reported 26 Jun 2013 · FDA Enforcement Report
Actiq (oral transmucosal fentanyl citrate) 200 mcg recalled
Teva Pharmaceuticals USA is recalling Actiq (oral transmucosal fentanyl citrate) 200 mcg, lozenge on a stick, a)Single Blister (, distributed in 7 states. The recall was initiated on 28 May 2013 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-606-2013
- FDA event ID
- 65298
- Recalling firm
- Teva Pharmaceuticals USA, Sellersville, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 May 2013
- FDA classified
- 19 Jun 2013
- Reported
- 26 Jun 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 28 May 2013 | Recall initiated by company | |
| 19 Jun 2013 | Classified by FDA | +22 days |
| 26 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 Dissolution Specification; during stability testing
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
Actiq (oral transmucosal fentanyl citrate) 200 mcg, lozenge on a stick, a)Single Blister (NDC 63459-502-01), b) 30 count carton (NDC 63459-502-30), Rx only, Manufactured by: Cephalon, Inc., Salt Lake City, UT 84116
Where it was distributed
Product was distributed within the United States to FL, IL, MA, MO, MS, OH and TX. No government or foreign distribution.
Questions about this recall
Is Actiq (oral transmucosal fentanyl citrate) 200 mcg, lozenge on a stick, a)Single Blister ( recalled?
Yes. Teva Pharmaceuticals USA recalled Actiq (oral transmucosal fentanyl citrate) 200 mcg, lozenge on a stick, a)Single Blister ( on 28 May 2013. The recall is Class II and its status is Terminated. Recall number D-606-2013.
Why was it recalled?
Failed Dissolution Specification; during stability testing
Which lots are affected?
Lot C88583, exp. 06/15
Where was it sold?
Product was distributed within the United States to FL, IL, MA, MO, MS, OH and TX. No government or foreign distribution.
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 21 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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|---|---|---|---|---|---|
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