Actavis Recalls Fentanyl Transdermal Systems Due to Impurity Specifications
Actavis is recalling Fentanyl Transdermal Systems, 50 mcg/h, because they failed impurities and degradation specifications.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which indicates the violation is not likely to cause adverse health consequences.
Plain-English summary
Actavis is recalling Fentanyl Transdermal Systems, 50 mcg/h, manufactured by Watson Laboratories, Inc. and distributed by Watson Pharma, Inc. The recall involves 98,952 boxes of the product, which is available by prescription only.
The recall was initiated because the product failed impurities and degradation specifications. The affected lot is identified as Patch 453658 and Carton 453658A, with an expiration date of 09/13. The product was distributed nationwide.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration date listed above. If the product matches the recalled description, it should be returned to the pharmacy or point of distribution for replacement or refund.
The recalled product
- Product
- 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.
- Manufacturer
- Actavis
- Category
- Drug — Transdermal Patch
- Hazard
- Affected units
- 98,952
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #: Patch 453658
- Carton 453658A
- Exp 09/13
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Actavis
See all →- ModerateActavis Recalls Subpotent Gelnique Oxybutynin Chloride Gel Samples
FDA (Drugs) · 2014-03-05
- SevereActavis Recalls Fentanyl Transdermal Systems Due to Subpotent Product
FDA (Drugs) · 2012-10-03
Same hazard · impurities
See all →- LowDabigatran Etexilate Capsules Recalled Due to Impurity Specification Failure
FDA (Drugs) · 2026-08-05
- ModerateGlycopyrrolate Oral Solution Recalled Due to Failed Impurities and Degradation Specifications
FDA (Drugs) · 2026-07-29
- ModerateMethohexital Sodium for Injection Recalled for Failed Impurities and Degradation Specifications
FDA (Drugs) · 2026-07-15
- ModerateMethohexital Sodium 100 mg/10 mL Compounded Drug Recalled Nationwide
FDA (Drugs) · 2026-07-15
- LowFexofenadine Hydrochloride Tablets 180 mg Recalled for Impurities
FDA (Drugs) · 2026-07-08