Actavis Recalls 5 mg ADHD Tablets Due to Impurity Failures
Actavis Elizabeth LLC recalls specific lots of 5 mg Dextroamphetamine/Amphetamine tablets due to failed impurity specifications. Check your bottle's lot number.
Use caution until it’s fixed
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Contact the company
What happened, in plain English
Actavis Elizabeth LLC is recalling 38,507 bottles of 5 mg Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate tablets because they failed impurity specifications. The issue involves out-of-specification levels of impurities in the medication. This recall affects specific lots distributed nationwide. Read more at govinfonow.com/recall/43139-actavis-recalls-5-mg-adhd-tablets-due-to-impurity-failures.
Source Summary by GovInfoNow · govinfonow.com/recall/43139-actavis-recalls-5-mg-adhd-tablets-due-to-impurity-failures · Updated October 11, 2026 · FDA enforcement record: FDA #D-0816-2016
Cite this page
“Actavis Recalls 5 mg ADHD Tablets Due to Impurity Failures.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43139-actavis-recalls-5-mg-adhd-tablets-due-to-impurity-failures. Based on FDA recall #D-0816-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0816-2016%22&limit=1).
Why it’s dangerous
The tablets contain impurities that exceed established safety specifications. While the record does not detail specific health effects, taking medication with failed impurity standards can potentially compromise its safety or efficacy.
Who’s affected
Patients who have been prescribed this specific 5 mg combination ADHD medication by a doctor. Consumers who purchased these bottles from pharmacies across the United States between the manufacturing dates and the recall date of February 16, 2016.
How to tell if you have this one
Look for a white bottle containing 100 Rx-only tablets manufactured by Actavis Elizabeth LLC in Elizabeth, NJ. Check the label for NDC 45963-743-11 and one of the following lot numbers: 5245M141 (Expiry 6/16), 0953C151 (Expiry 8/16), 1728D151 (Expiry 9/16), or 3205G152 (Expiry 3/17).
- Brand
Actavis- Category
Drug
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
US: Nationwide
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| 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.; Lot #: 2172#141, Expiry: 3/16; Lot #: 4217K141, Expiry: 3/16; Lot #: 0420A151, Expiry: 7/16; Lot #: 0421A151, Expiry: 7/16; Lot #: 0854B151, Expiry: 10/16; Lot #: 1329C151, Expiry: 10/16; Lot #: 2692F151, Expiry; 2/17; Lot #: 3202G151, Expiry: 3/17; Lot #: 3796J151, Expiry: 3/17; Lot #: 3797J151, Expiry: 4/17. | 114,388 Bottles |
| 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.; 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. | 257,746 Bottles |
| 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.; Lot #: 1879E141, Expiry 02/16; Lot #: 1880E141, Expiry: 02/16; Lot #: 5034M142; Expiry: 5/16; Lot #: 0422A151, Expiry: 7/16; Lot #: 0423A151, Expiry: 7/16; Lot #: 1053C151, Expiry: 8/16; Lot #: 1054C151, Expiry: 8/16; Lot #: 2197E152, Expiry: 11/16; Lot #: 2198E151, Expiry: 12/16; Lot #: 2662F151, Expiry: 12/16; Lot #: 2672F152, Expiry: 3/17; Lot #: 3121G152, Expiry: 3/17; Lot #: 3798J151, Expiry: 4/17; Lot #: 5104M151, Expiry: 5/17. | 182,378 Bottles |
| 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.; Lot #: 5245M141, Expiry: 6/16; Lot #: 0953C151, Expiry date: 8/16Lot #: 1728D151, Expiry: 9/16; Lot #: 3205G152, Expiry: 3/17. | 38,507 Bottles |
What to do — step by step
Check Your Bottle
Verify if your medication matches the recalled lot numbers and NDC listed in the record.
Contact Your Pharmacist
The recall record does not specify a consumer return or replacement process; consult your pharmacy or healthcare provider for guidance on how to proceed.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US: Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 19 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
What is the NDC number for the recalled product?
The National Drug Code (NDC) is 45963-743-11.
How many bottles were recalled?
A total of 38,507 bottles were included in this recall.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0816-2016 (February 16, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0816-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.