CLASS II Drug recall · Reported 13 Apr 2016 · FDA Enforcement Report
Dextroamphetamine Saccharate, Amphetamine Aspartate recalled
Actavis Elizabeth is recalling Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and, distributed nationwide in the US. The recall was initiated on 16 Feb 2016 and the FDA has classified it as Class II.
Check your package
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-0814-2016
- FDA event ID
- 73474
- Recalling firm
- Actavis Elizabeth, Elizabeth, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Feb 2016
- FDA classified
- 7 Apr 2016
- Reported
- 13 Apr 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- ADHD Medication
Timeline
| 16 Feb 2016 | Recall initiated by company | |
| 7 Apr 2016 | Classified by FDA | +51 days |
| 13 Apr 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications: Out of specification for impurities.
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 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.
Where it was distributed
US: Nationwide
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Which lots are affected?
Lot #: 3992J141, Expiry: 5/16; Lot #: 3993J142, Expiry: 5/16; Lot #: 0695B151, Expiry: 7/16; Lot #: 0696B151, Expiry: 7/16; Lot #: 0378A151, Expiry: 7/16; Lot #: 0379A151, Expiry: 7/16; Lot #: 0697B151, Expiry: 8/16; Lot #: 2427F151, Expiry: 11/16; Lot #: 1947E151, Expiry: 11/16; Lot #: 1330C151, Expiry: 11/16; Lot #: 1331C151, Expiry: 11/16; Lot #: 1946E151, Expiry: 11/16; Lot #: 3652H151, Expiry: 2/17; Lot #: 3653H151, Expiry: 3/17, Lot #: 3654H151, Expiry: 3/17; Lot #: 4251K151, Expiry: 3/17; Lot #: 4250K151, Expiry: 4/17; Lot #: 4252K151, Expiry: 4/17; Lot #: 4249K151, Expiry: 4/17; Lot #: 5101M151, Expiry: 5/17.
Where was it sold?
US: 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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 73474This product is part of a recall event; the main page for the event is Dextroamphetamine Saccharate, Amphetamine Aspartate recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Dextroamphetamine Saccharate, Amphetamine Aspartate recalled | Actavis Elizabeth | Potency & Assay | Nationwide | |
| CLASS II | Dextroamphetamine Saccharate, Amphetamine Aspartate recalled | Actavis Elizabeth | Potency & Assay | Nationwide | |
| CLASS II | Dextroamphetamine Saccharate, Amphetamine Aspartate recalled | Actavis Elizabeth | Potency & Assay | Nationwide |
More recalls from Actavis Elizabeth
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | NIFEdipine Capsules USP, 10 mg recalled by Actavis Elizabeth | Actavis Elizabeth | Other | NJ |
| Drug | CLASS II | Dextroamphetamine Saccharate, Amphetamine Aspartate recalled | Actavis Elizabeth | Potency & Assay | Nationwide |
| Drug | CLASS II | Dextroamphetamine Saccharate, Amphetamine Aspartate recalled | Actavis Elizabeth | Potency & Assay | Nationwide |
| Drug | CLASS II | Dextroamphetamine Saccharate, Amphetamine Aspartate recalled | Actavis Elizabeth | Potency & Assay | Nationwide |
| Drug | CLASS II | Dextroamphetamine Sulfate Extended-Release Capsules, 15 mg recalledDextroamphetamine Sulfate | Actavis Elizabeth | Potency & Assay | Nationwide |