Food, drugs, devices › Teva Pharmaceuticals USA

Drug recall: Fentanyl Transdermal System. 25 mcg/h, packaged in 5 pouch system cartons (NDC 0591-3198-72), Rx Only, Manufactured by:

FDA enforcement event 79062 · Class III · initiated 29 Jan 2018 · status Terminated · terminated 5 Sep 2018

DrugVoluntary: Firm initiated4 product recordsNorth Wales, PA

FDA enforcement event 79062 is a drug recall by Teva Pharmaceuticals USA of North Wales, PA, initiated 29 Jan 2018 and classified Class III, with 4 product records.

FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 29% of the 367 drug enforcement events initiated in 2018 carry the same class.

Status: Terminated, terminated 5 Sep 2018. Initiation: voluntary: firm initiated. Teva Pharmaceuticals USA has 98 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Teva Pharmaceuticals USA, North Wales, PA.

Reason for recall

"Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits"

Distribution

"Distributed nationwide within the United States"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-0540-2018	Fentanyl Transdermal System. 25 mcg/h, packaged in 5 pouch system cartons (NDC 0591-3198-72), Rx Only, Manufactured by: Actavis Laboratoies UT, Inc. Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA. Individual pouch NDC 0591-3198-54.	1,118,046 (5 pouches/carton)	Class III	Terminated	14 Feb 2018
D-0541-2018	Fentanyl Transdermal System, 50 mcg/h, packaged in 5 pouch system cartons (NDC 0591-3212-72), Rx Only, Manufactured by: Actavis Laboratoies UT, Inc. Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA. Individual pouch NDC 0591-3212-54.	929,916 (5 pouches/carton)	Class III	Terminated	14 Feb 2018
D-0542-2018	Fentanyl Transdermal System. 75 mcg/h, packaged in 5 pouch system (NDC 0591-3213-72), Rx Only, Manufactured by: Actavis Laboratoies UT, Inc. Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA. Individual pouch NDC 0591-3213-54.	576, 760 (5 pouches/carton)	Class III	Terminated	14 Feb 2018
D-0543-2018	Fentanyl Transdermal System, 100 mcg/h, packaged in 5 pouch system (NDC 0591-3214-72), Rx Only, Manufactured by: Actavis Laboratoies UT, Inc. Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA. Individual pouch NDC 0591-3214-54.	554, 562 (5 pouches/carton)	Class III	Terminated	14 Feb 2018

Context

29%of 2018 drug events are Class III367 events that year

4product records in this eventfirm median: 1

98events on this register for the firm

Other enforcement events for Teva Pharmaceuticals USA

Initiated	Product (first record)	Type	Class	Records
18 Jan 2022	Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 mg/10 mg, 100-count bottle, Rx Only, Manufa	Drug	Class II	1
10 Jan 2022	Tretinoin Capsules, 10 mg, 100 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-08	Drug	Class II	1
7 Jan 2022	Mimvey (estradiol and norethindrone acetate tablets USP), 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx only, Manuf	Drug	Class III	2
31 Dec 2021	MethylPREDNISolone Acetate Injectable Suspension USP 400 mg/10mL (40mg/mL), 10 mL Multiple-Dose Vial, Rx Only, Manufactu	Drug	Class II	2
16 Dec 2021	Penicillin V Potassium for Oral Solution, USP 125 mg (200,000 U) per 5 mL a) 100 mL (NDC 00093-4125-73) and b) 200 mL (N	Drug	Class II	1
8 Dec 2021	Brinzolamide Ophthalmic Suspension, USP 1%, packaged as a)10 ml dropper bottles (NDC 0591-2127-79), and b) 15 ml dropper	Drug	Class II	1
28 Oct 2021	Clonidine Transdermal System, USP 0.1 mg/day, 4 patches per carton, Rx only, Manufactured by: Actavis Laboratories, UT I	Drug	Class III	1
27 Oct 2021	Cartia XT (Diltiazem Hydrochloride Extended-Release Capsules, USP) 120 mg, Rx Only, 90 capsules, labelled as (a) Manufac	Drug	Class II	1
22 Sep 2021	AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Sample Not For Sale, R	Drug	Class II	5
29 Jul 2021	Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratori	Drug	Class II	3

All 98 events for Teva Pharmaceuticals USA

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits"

What does Class III mean?

FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

Where was the product distributed?

FDA's distribution pattern field reads: "Distributed nationwide within the United States"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 5 Sep 2018. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.