The Recall Desk

FDA (Drugs) recall action 97504

Granules Pharmaceuticals Inc. recalled 5 products on 2025-10-01

The FDA (Drugs) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.

Products
5
Announced
2025-10-01
Critical
0
Units
49,033

Why these products were recalled

Failed Impurities/Degradation Specifications:

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–5 of 5

  • ModerateFDA (Drugs)··2025-10-01

    Amphetamine extended-release capsules 10 mg recalled over failed degradation specifications

    Mixed amphetamine salts extended-release capsules, 10 mg, lot GPC250159A, are recalled nationwide after failing impurities and degradation specifications. 11,895 bottles are affected.

    Product
    DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2025-10-01

    Amphetamine extended-release capsules 20 mg recalled over impurity and degradation results

    Mixed amphetamine salts extended-release capsules, 20 mg, lot GPC250179A, are recalled nationwide after failing impurities and degradation specifications. 11,909 bottles are affected.

    Product
    DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
    Category
    Distribution
    0 states
  • LowFDA (Drugs)··2025-10-01

    Dextroamphetamine Saccharate and Amphetamine Capsules Recalled for Failed Impurities Specifications

    Granules Pharmaceuticals Inc. is recalling 3,384 bottles of mixed-salt amphetamine extended-release capsules (5 mg) distributed nationwide due to failed impurities and degradation specifications.

    Product
    DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2025-10-01

    Amphetamine extended-release capsules 15 mg recalled after impurity testing failure

    Mixed amphetamine salts extended-release capsules, 15 mg, lot GPC250178A, are recalled nationwide after failing impurities and degradation specifications. 9,917 bottles are affected.

    Product
    DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2025-10-01

    Amphetamine extended-release capsules 30 mg recalled after failing impurity specifications

    Mixed amphetamine salts extended-release capsules, 30 mg, lot GPC250181A, are recalled nationwide after failing impurities and degradation specifications. 11,928 bottles are affected.

    Product
    DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
    Category
    Distribution
    0 states