Food, drugs, devices › Actavis Elizabeth LLC

Drug recall: Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 10 mg,

FDA enforcement event 73474 · Class II · initiated 16 Feb 2016 · status Terminated · terminated 22 Sep 2017

DrugVoluntary: Firm initiated4 product recordsElizabeth, NJ

Actavis Elizabeth LLC (Elizabeth, NJ) initiated this drug recall on 16 Feb 2016; FDA lists 4 product records under event 73474, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 46% of the 288 drug enforcement events initiated in 2016 carry the same class.

Status: Terminated, terminated 22 Sep 2017. Initiation: voluntary: firm initiated. Actavis Elizabeth LLC has 9 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

Actavis Elizabeth LLC, Elizabeth, NJ.

Reason for recall

"Failed Impurities/Degradation Specifications: Out of specification for impurities."

Distribution

"US: Nationwide"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-0813-2016	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 10 mg, 100 ct. bottle, Rx Only. Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B, Morristown, NJ 07960. NDC: 45963-745-11.	114,388 Bottles	Class II	Terminated	13 Apr 2016
D-0814-2016	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 20 mg, 100 ct. bottle, Rx Only. Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B, Morristown, NJ 07960. NDC: 45963-748-11.	257,746 Bottles	Class II	Terminated	13 Apr 2016
D-0815-2016	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 30 mg, 100 ct. bottle, Rx Only. Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B, Morristown, NJ 07960. NDC: 45963-749-11.	182,378 Bottles	Class II	Terminated	13 Apr 2016
D-0816-2016	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 5 mg, 100 ct. bottle, Rx Only. Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B, Morristown, NJ 07960. NDC: 45963-743-11.	38,507 Bottles	Class II	Terminated	13 Apr 2016

Context

46%of 2016 drug events are Class II288 events that year

4product records in this eventfirm median: 1

9events on this register for the firm

Other enforcement events for Actavis Elizabeth LLC

Initiated	Product (first record)	Type	Class	Records
6 Oct 2016	NIFEdipine Capsules USP, 10 mg, Rx only, 100 count bottle, Manufactured and distributed by: Actavis Elizabeth LLC, 200 E	Drug	Class III	1
10 Feb 2015	Dextroamphetamine Sulfate Extended-Release Capsules, 15 mg, 90-count bottles, Rx Only, Manufactured by: Actavis Elizabet	Drug	Class II	1
15 Dec 2014	Gabapentin Capsules, USP, 400 mg, Rx Only, a) 100 capsules per bottle, NDC 14550-513-02, b) 500 Capsules per bottle, NDC	Drug	Class II	3
10 Feb 2014	Alprazolam 1 mg Tablets, USP, 500 count Bottle, Rx Only , C IV, Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue	Drug	Class II	1
4 Feb 2014	Alprazolam Extended-Release Tablets, USP, 3 mg, 60-count tablets per bottle, Rx only, Manufactured by: Actavis Elizabeth	Drug	Class II	1
6 Nov 2013	Clonazepam Tablets, USP 2 mg 100 tablets Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue, Elizabeth, NJ 0737 US	Drug	Class II	1
9 Oct 2013	Alprazolam Orally Disintegrating Tablets, USP 2 mg, 100 count bottles, Rx Only, MFG. BY ACTAVIS ELIZABETH LLC., Elizabet	Drug	Class II	1
13 Feb 2013	Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended	Drug	Class III	1

All 9 events for Actavis Elizabeth LLC

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Failed Impurities/Degradation Specifications: Out of specification for impurities."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "US: Nationwide"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 22 Sep 2017. "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.