Impax Laboratories Dextroamphetamine Sulfate Tablets Recall

Why it was recalled

Failed Impurities/Degradation Specifications

Product description

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 numbers, UPCs & expiration codes

Lot #: 112565, Exp 03/17; 113458, Exp 08/17

Where it was sold

Nationwide

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0826-2016
Classification: Class II
Status: Terminated
Recall initiated: Mar 14, 2016
FDA report date: Apr 27, 2016
Quantity: 18,936 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Impax Laboratories, Inc.

Original FDA data

Every field from FDA enforcement report D-0826-2016, exactly as published.

Show all FDA fields

City: Middlesex
State: NJ
Status: Terminated
Country: United States
Event ID: 73679
Address: 215 Wood Ave
Code information: Lot #: 112565, Exp 03/17; 113458, Exp 08/17
Postal code: 08846-2554
Report date: Apr 27, 2016
Product type: Drugs
Recall number: D-0826-2016
Classification: Class II
Recalling firm: Impax Laboratories, Inc.
Product quantity: 18,936 bottles
Termination date: Feb 9, 2018
Reason for recall: Failed Impurities/Degradation Specifications
Voluntary / mandated: Voluntary: Firm initiated
Product description: Dextroamphetamine Sulfate Tablets USP, 5 mg, 100-count bottle, Rx only, Manufactured and Distributed by: CorePharma, LLC, Middlesex, NJ 08846, NDC 64720-215-10
Distribution pattern: Nationwide
Recall initiation date: Mar 14, 2016
Initial firm notification: Letter
Center classification date: Apr 21, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0826-2016, published Apr 27, 2016. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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