Granules Pharmaceuticals Dextroamphetamine Saccharate Recall

Why it was recalled

Failed Impurities/Degradation Specifications:

Product description

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 20 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-032-01

Lot numbers, UPCs & expiration codes

Lot#: GPC250179A, Exp Date: 06-22-2027

Where it was sold

Distributed Nationwide in the USA

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-0672-2025
Classification: Class III
Status: Ongoing
Recall initiated: Aug 28, 2025
FDA report date: Oct 1, 2025
Quantity: 11,909 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Granules Pharmaceuticals Inc.

Original FDA data

Every field from FDA enforcement report D-0672-2025, exactly as published.

Show all FDA fields

City: Chantilly
State: VA
Status: Ongoing
Country: United States
Event ID: 97504
Address: 3701 Concorde Pkwy
Code information: Lot#: GPC250179A, Exp Date: 06-22-2027
Postal code: 20151-1126
Report date: Oct 1, 2025
Product type: Drugs
Recall number: D-0672-2025
Classification: Class III
Recalling firm: Granules Pharmaceuticals Inc.
Product quantity: 11,909 bottles
Reason for recall: Failed Impurities/Degradation Specifications:
Voluntary / mandated: Voluntary: Firm initiated
Product description: Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 20 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-032-01
Distribution pattern: Distributed Nationwide in the USA
Recall initiation date: Aug 28, 2025
Initial firm notification: E-Mail
Center classification date: Sep 24, 2025

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0672-2025, published Oct 1, 2025. 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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