Class II · Moderate risk
fentaNYL Citrate
Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of the IV bag expiry (07/31/2026 and 11/30/2026) and the product expiry (12/09/2026).
Fentanyl Transdermal System
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation Specifications
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
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.
Affected NDCs
0591-3212-54
0591-3212-72
Compare with the code on your package — it is the most precise check available.
Drug: Fentanyl
- Recalling firm
- Actavis
- NDC code
- 0591-3212-54
- Origin
- UT, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-599-2013 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Fentanyl recalls
See all
Class II · Moderate risk
fentaNYL Citrate
Subpotent Drug
Class II · Moderate risk
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride
cGMP deviations.
Class II · Moderate risk
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride
cGMP deviations.
Class II · Moderate risk
fentaNYL Citrate Injectable Solution
cGMP deviations.
Other recalls by Actavis
All 2013 recalls
Class III · Low risk
Levofloxacin Ophthalmic Solution
Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at the 18 month stability time point.
Class II · Moderate risk
Glipizide extended-release tablets
Failed Dissolution Specifications. Above out of specification for dissolution rate observed at the 10 hour testing point.
Class III · Low risk
Albuterol Sulfate Inhalation Solution
Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
Class III · Low risk
Hydrocortisone and acetic acid otic solution
Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related compound G were obtained at 12-month (at expiry) stability time-point for room temperature sample(s).
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