Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate Capsule, Extended Release
FDA Recall NDC 70010-032
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 5 recorded enforcement report(s) associated with Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate (NDC 70010-032). A significant event, classified as Class III, was initiated on Aug 28, 2025 by Granules Pharmaceuticals Inc.. The reported reason for this action was: "Failed Impurities/Degradation Specifications:"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
August 2025 Class III Recall: Failed Impurities/Degradation Specifications
Recall Number
Class III Ongoing
Failed Impurities/Degradation Specifications:
Aug 28, 2025
Oct 01, 2025
9,917 bottles
Recall Profile & Regulatory Data
Event ID
97504
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Granules Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the USA
Product Description
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 15 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-031-01
Batch or Lot Expiration Information
Lot# : GPC250178A, Exp Date: 06-22-2027
Affected Packages Involved in this Recall
70010-029-01Product
70010-030-01Product
70010-031-01Product
70010-032-01Product
70010-033-01Product
70010-034-01Product
August 2025 Class III Recall: Failed Impurities/Degradation Specifications
Recall Number
Class III Ongoing
Failed Impurities/Degradation Specifications:
Aug 28, 2025
Oct 01, 2025
11,928 bottles
Recall Profile & Regulatory Data
Event ID
97504
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Granules Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the USA
Product Description
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 30 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-034-01
Batch or Lot Expiration Information
Lot# : GPC250181A, Exp Date: 06-19-2027
Affected Packages Involved in this Recall
70010-029-01Product
70010-030-01Product
70010-031-01Product
70010-032-01Product
70010-033-01Product
70010-034-01Product
August 2025 Class III Recall: Failed Impurities/Degradation Specifications
Recall Number
Class III Ongoing
Failed Impurities/Degradation Specifications:
Aug 28, 2025
Oct 01, 2025
11,909 bottles
Recall Profile & Regulatory Data
Event ID
97504
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Granules Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the USA
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
Batch or Lot Expiration Information
Lot# : GPC250179A, Exp Date: 06-22-2027
Affected Packages Involved in this Recall
70010-029-01Product
70010-030-01Product
70010-031-01Product
70010-032-01Product
70010-033-01Product
70010-034-01Product
August 2025 Class III Recall: Failed Impurities/Degradation Specifications
Recall Number
Class III Ongoing
Failed Impurities/Degradation Specifications:
Aug 28, 2025
Oct 01, 2025
11,895 bottles
Recall Profile & Regulatory Data
Event ID
97504
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Granules Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the USA
Product Description
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 10 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-030-01
Batch or Lot Expiration Information
Lot# : GPC250159A, Exp Date: 06-22-2027
Affected Packages Involved in this Recall
70010-029-01Product
70010-030-01Product
70010-031-01Product
70010-032-01Product
70010-033-01Product
70010-034-01Product
August 2025 Class III Recall: Failed Impurities/Degradation Specifications
Recall Number
Class III Ongoing
Failed Impurities/Degradation Specifications:
Aug 28, 2025
Oct 01, 2025
3,384 bottles
Recall Profile & Regulatory Data
Event ID
97504
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Granules Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the USA
Product Description
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 5 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-029-01
Batch or Lot Expiration Information
Lot# : GPC250158A, Exp Date: 06-22-2027
Affected Packages Involved in this Recall
70010-029-01Product
70010-030-01Product
70010-031-01Product
70010-032-01Product
70010-033-01Product
70010-034-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
