Corepharma Dextroamphetamine Sulfate Recall: Impurity Issues
Corepharma recalls 67,428 bottles of Dextroamphetamine Sulfate Tablets due to failed impurity specifications. Check your lot numbers for details.
Recall notice
Failed Impurities/Degradation Specifications
Contact the company
What happened, in plain English
Corepharma is recalling specific lots of Dextroamphetamine Sulfate Tablets USP, 10 mg, because they failed impurity and degradation specifications. The recall affects 67,428 bottles distributed nationwide. No other health risks or remedies are described in the record. Read more at govinfonow.com/recall/43114-corepharma-dextroamphetamine-sulfate-recall-impurity-issues.
Source Summary by GovInfoNow · govinfonow.com/recall/43114-corepharma-dextroamphetamine-sulfate-recall-impurity-issues · Updated October 11, 2026 · FDA enforcement record: FDA #D-0825-2016
Cite this page
“Corepharma Dextroamphetamine Sulfate Recall: Impurity Issues.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43114-corepharma-dextroamphetamine-sulfate-recall-impurity-issues. Based on FDA recall #D-0825-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0825-2016%22&limit=1).
Why it’s dangerous
The tablets failed impurity and degradation specifications. The record does not explain what specific impurities were found or how they might affect patient safety.
Who’s affected
Patients who have been prescribed Dextroamphetamine Sulfate Tablets USP, 10 mg, manufactured by Corepharma and holding one of the listed lot numbers. The record does not specify which health conditions are treated with this medication.
How to tell if you have this one
Check your bottle for the NDC 64720-0216-10 and one of the following lot numbers with their expiration dates: Lot # 112579, 112580 (Exp 03/17); 111013A (Exp 04/16); 111014 (Exp 05/16); 113292, 113332, 113386, 113387 (Exp 07/17); 111671, 111673 (Exp 09/16); 113806, 113807 (Exp 10/17); 111874, 111875, 111876 (Exp 11/16).
- Brand
Corepharma- Category
Drug
All 2 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
Nationwide
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0825-2016 | Dextroamphetamine Sulfate Tablets USP, 10 mg, 100-count bottle, Rx only, Manufactured and Distributed by: Corepharma, LLC, Middlesex, NJ 08846, NDC 64720-0216-10; Lot # 112579, 112580, Exp 03/17; 111013A, Exp 04/16; 111014, Exp 05/16; 113292, 113332, 113386, 113387, Exp 07/17; 111671,111673, Exp 09/16; 113806, 113807, Exp 10/17; 111874, 111875, 111876, Exp 11/16 | 67,428 bottles |
| D-0826-2016 | Dextroamphetamine Sulfate Tablets USP, 5 mg, 100-count bottle, Rx only, Manufactured and Distributed by: CorePharma, LLC, Middlesex, NJ 08846, NDC 64720-215-10; Lot #: 112565, Exp 03/17; 113458, Exp 08/17 | 18,936 bottles |
What to do — step by step
Check your medication bottle
Verify if your Dextroamphetamine Sulfate Tablets match the recalled NDC and lot numbers listed in the record.
Contact your pharmacist or doctor
The record does not specify a remedy, so you should consult your healthcare provider for guidance on what to do next.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “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 23 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.
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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-0825-2016 (March 14, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0825-2016 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.