CLASS II Drug recall · Reported 3 Aug 2016 · FDA Enforcement Report

Dextroamphetamine Sulfate Extended-Release Capsules, 10 mg recalled

Actavis is recalling Dextroamphetamine Sulfate Extended-Release Capsules, 10 mg, distributed nationwide in the US. The recall was initiated on 11 Jul 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: 3803J141, Exp. 7/2016

Quantity recalled8,062 units

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-1448-2016
FDA event ID: 74713
Recalling firm: Actavis, Parsippany, NJ
Classification: Class II
Status: Terminated
Recall initiated: 11 Jul 2016
FDA classified: 26 Jul 2016
Reported: 3 Aug 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: ADHD Medication

Timeline

11 Jul 2016	Recall initiated by company
26 Jul 2016	Classified by FDA	+15 days
3 Aug 2016	Published in enforcement report	+8 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 Specifications

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

Dextroamphetamine Sulfate Extended-Release Capsules, 10 mg, 90- count bottles, Rx Only Manufactured by: Actavis Elizabeth LLC Elizabeth, NJ 07207 USA; Distributed by: Actavis Pharma, Inc Parsippany, NJ 07054 USA NDC 45963-304-09

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Failed Dissolution Specifications

Which lots are affected?

Lot #: 3803J141, Exp. 7/2016

Where was it sold?

Nationwide

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 12 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Actavis

All 20

Reported	Class	Recall	Company	Reason	Where
15 Mar 2017Drug	CLASS III	Levofloxacin Ophthalmic Solution, 0.5%, Sterile recalled by Actavis	Actavis	Potency & Assay	Nationwide
22 Feb 2017Drug	CLASS II	Glipizide extended-release tablets, 2.5mg recalled by Actavis	Actavis	Potency & Assay	Nationwide
1 Feb 2017Drug	CLASS III	Albuterol Sulfate Inhalation Solution, USP, 0.021% (0.63 mg / Vials recalled	Actavis	Potency & Assay	Nationwide
31 Aug 2016Drug	CLASS III	Hydrocortisone and acetic acid otic solution recalled by Actavis	Actavis	Potency & Assay	Nationwide
31 Aug 2016Drug	CLASS III	Acetasol HC (hydrocortisone and acetic acid otic solution USP) recalled	Actavis	Potency & Assay	Nationwide

Other Dextroamphetamine recalls

All 11

Reported	Class	Recall	Company	Reason	Where
8 Jul 2026Drug	CLASS II	Dextroamphetamine Saccharate recalled by Lannett CompanyDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate	Lannett	Packaging Defects	Nationwide
27 Nov 2024Drug	CLASS II	Xelstrym (dextroamphetamine) transdermal system recalledXelstrym	Noven Pharmaceuticals	Packaging Defects	Nationwide
7 Feb 2024Drug	CLASS I	Zenzedi (Dextroamphetamine Sulfate) CII Tablets, USP, 30 mg recalledZenzedi	Azurity Pharmaceuticals	Packaging Defects	Nationwide
27 Apr 2016Drug	CLASS II	Dextroamphetamine Sulfate Tablets USP, 5 mg recalled	Impax Laboratories	Potency & Assay	Nationwide
27 Apr 2016Drug	CLASS II	Dextroamphetamine Sulfate Tablets USP, 10 mg recalled	Impax Laboratories	Potency & Assay	Nationwide