Medications & Supplements/Prescription Drugs

Granules Pharmaceuticals ADHD Medication Recalled for Impurity Issues

Agency Publication Date: September 24, 2025

Summary

Granules Pharmaceuticals Inc. is recalling 49,033 bottles of mixed salts amphetamine extended-release capsules (generic Adderall XR) across five different strengths. The recall was initiated because the medication failed specifications for impurities and degradation during testing. Consumers who have these products should contact their healthcare provider or pharmacist regarding their treatment, as the effectiveness or safety of the medication may be compromised.

Risk

The medication failed quality testing for impurities and degradation, which means the product may not meet safety or potency standards over time. While the risk is categorized as low, using degraded medication can result in reduced effectiveness of the treatment.

What You Should Do

Identify your medication by checking the NDC and lot numbers on the bottle label. This recall affects 100-count bottles of Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules.
Check for NDC 70010-029-01 (5 mg, Lot GPC250158A), NDC 70010-030-01 (10 mg, Lot GPC250159A), NDC 70010-031-01 (15 mg, Lot GPC250178A), NDC 70010-032-01 (20 mg, Lot GPC250179A), or NDC 70010-034-01 (30 mg, Lot GPC250181A). All affected lots have expiration dates in June 2027.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules (100-count)

Variants: 5 mg, 10 mg, 15 mg, 20 mg, 30 mg

Lot Numbers:

GPC250158A (Exp Date: 06-22-2027)

GPC250159A (Exp Date: 06-22-2027)

GPC250178A (Exp Date: 06-22-2027)

GPC250179A (Exp Date: 06-22-2027)

GPC250181A (Exp Date: 06-19-2027)

NDC:

70010-029-01

70010-030-01

70010-031-01

70010-032-01

70010-034-01

Mixed Salts of a Single Entity Amphetamine Product; Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97504

Status: Active

Manufacturer: Granules Pharmaceuticals Inc.

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 5 products (3,384 bottles; 11,895 bottles; 9,917 bottles; 11,909 bottles; 11,928 bottles)

Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify your medication by checking the NDC and lot numbers on the bottle label. This recall affects 100-count bottles of Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules.

Check for NDC 70010-029-01 (5 mg, Lot GPC250158A), NDC 70010-030-01 (10 mg, Lot GPC250159A), NDC 70010-031-01 (15 mg, Lot GPC250178A), NDC 70010-032-01 (20 mg, Lot GPC250179A), or NDC 70010-034-01 (30 mg, Lot GPC250181A). All affected lots have expiration dates in June 2027.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules (100-count)

Variants: 5 mg, 10 mg, 15 mg, 20 mg, 30 mg

Lot Numbers:

GPC250158A (Exp Date: 06-22-2027)

GPC250159A (Exp Date: 06-22-2027)

GPC250178A (Exp Date: 06-22-2027)

GPC250179A (Exp Date: 06-22-2027)

GPC250181A (Exp Date: 06-19-2027)

NDC:

70010-029-01

70010-030-01

70010-031-01

70010-032-01

70010-034-01

Mixed Salts of a Single Entity Amphetamine Product; Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151