Granules Pharmaceuticals Recalls

4 recalls found for Granules Pharmaceuticals. Check if any of your products are affected.

Health & Personal Care
HIGH
FDA DRUG

Granules Pharmaceuticals Recalls 3,384 Bottles of Dextroamphetamine ER Capsules for Impurity Issues

Granules Pharmaceuticals Inc. recalls 3,384 bottles of Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules, 5 mg, 100 capsules per bottle, NDC 70010-029-01, Lot GPC250158A, Exp 06-22-2027. The recall concerns failed impurities/degradation specifications. Healthcare providers and consumers should stop using the

Granules Pharmaceuticals
Failed Impurities/Degradation
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Health & Personal Care
HIGH
FDA DRUG

Granules Pharmaceuticals Dextroamphetamine Mixed Salts ER Capsules Recall 11,909 Bottles (2025)

Granules Pharmaceuticals recalled 11,909 bottles of Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules sold nationwide to pharmacies and health care providers. The recall stems from a failure to meet impurities and degradation specifications. Patients taking this prescription should stop using the product and

Granules Pharmaceuticals
Failed Impurities/Degradation
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Health & Personal Care
HIGH
FDA DRUG

Granules Pharmaceuticals Recall: 11,928 Bottles of Dextroamphetamine Mixed Salts Suspended for Impur

Granules Pharmaceuticals recalled 11,928 bottles of an extended-release amphetamine product. The recall date is 2025-08-28 for Dextroamphetamine saccharate and related salts. The FDA lists the reason as failed impurities and degradation specifications. The recall remains active as of 2025-10-01. Health care providers and patients should stop use and contact the manufacturer for guidance.

Granules Pharmaceuticals
Failed Impurities/Degradation
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Health & Personal Care
HIGH
FDA DRUG

Granules Pharmaceuticals Amphetamine Capsules Recalled for Impurities Degradation Standards (2025)

Granules Pharmaceuticals recalled 9,917 bottles of mixed-salts amphetamine extended-release capsules nationwide. The recall was issued August 28, 2025 and remains active. The FDA cited failed impurities/degradation specifications as the reason. Healthcare providers and consumers should stop using the product immediately and contact Granules Pharmaceuticals for guidance.

Granules Pharmaceuticals
Failed Impurities/Degradation
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Brand Statistics

Total Recalls
4
Pages
1

Related Brands

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate