The Recall Desk

Manufacturer

Granules Pharmaceuticals Inc.

11 recalls in our database name Granules Pharmaceuticals Inc. as the manufacturing or recalling firm.

What the numbers show

Total
11
Critical
0
Severe
1
Most recent
2026-02-11

Of the 11 recalls from Granules Pharmaceuticals Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (9%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–11 of 11

  • HighFDA (Drugs)·D-0305-2026·2026-02-11

    Trazodone tablets recalled over the presence of foreign tablets

    Granules Pharmaceuticals is recalling 71,424 bottles of Trazodone Hydrochloride, USP 50 mg, over the presence of foreign tablets or capsules.

    Product
    TRAZODONE HYDROCHLORIDE — TRAZODONE HYDROCHLORIDE (TRAZODONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0670-2025·2025-10-01

    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 (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0673-2025·2025-10-01

    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 (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0672-2025·2025-10-01

    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 (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0671-2025·2025-10-01

    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 (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0669-2025·2025-10-01

    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 (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0187-2025·2025-01-15

    Colchicine Capsules Recalled Due to Failed Dissolution Specifications

    Granules Pharmaceuticals is recalling Colchicine 0.6 mg capsules nationwide due to failed dissolution specifications detected during stability testing. Patients should contact their healthcare provider for guidance.

    Product
    COLCHICINE — COLCHICINE (COLCHICINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0192-2025·2025-01-15

    Metformin ER 500 mg tablets recalled due to foreign tablet contamination

    Granules Pharmaceuticals is recalling Metformin ER 500 mg tablets due to discovery of a Paracetamol tablet in one bottle. Patients taking the affected lot should verify their medication with their pharmacy.

    Product
    METFORMIN ER 500 MG — METFORMIN ER 500 MG (METFORMIN ER 500 MG)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0634-2024·2024-08-14

    Gabapentin 600 mg Tablets Recalled Due to Metformin Contamination

    Granules Pharmaceuticals Inc. is recalling Gabapentin Tablets 600 mg nationwide after fused Metformin ER tablets were found in bottles, creating a risk of unintended medication exposure.

    Product
    GABAPENTIN — GABAPENTIN (GABAPENTIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1386-2020·2020-07-22

    Granules Pharmaceuticals Recalls Metformin Hydrochloride Extended-Release Tablets

    Granules Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets due to FDA detection of N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels.

    Product
    METFORMIN — METFORMIN (METFORMIN ER 500 MG)
    Category
    Drug
    Distribution
    Distributed nationwide