The Recall Desk

Manufacturer

SUN PHARMACEUTICAL INDUSTRIES INC

79 recalls in our database name SUN PHARMACEUTICAL INDUSTRIES INC as the manufacturing or recalling firm.

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.

1–25 of 79

  • ModerateFDA (Drugs)·D-0477-2026·2026-04-22

    Prescription Fluocinonide Cream Recalled for Failed Viscosity Specifications

    SUN PHARMACEUTICAL is recalling Fluocinonide cream (0.05%) due to out-of-specification viscosity levels found during stability testing. The affected product was distributed nationwide.

    Product
    FLUOCINONIDE — FLUOCINONIDE (FLUOCINONIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0475-2026·2026-04-22

    Fluocinonide Cream Recalled Due to Failed Viscosity Specifications

    SUN Pharmaceutical is recalling 24,672 tubes of Fluocinonide 0.05% cream (Lot AD76252) distributed nationwide due to viscosity test failures discovered during stability testing.

    Product
    FLUOCINONIDE — FLUOCINONIDE (FLUOCINONIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0257-2026·2026-01-21

    Topical Antibiotic Clindamycin Phosphate Recalled for Out-of-Specification Impurities

    SUN Pharmaceutical recalls Clindamycin Phosphate 1% topical solution nationwide due to failed quality control tests showing out-of-specification impurities and assay results. Affected lots should be discontinued.

    Product
    CLINDAMYCIN PHOSPHATE — CLINDAMYCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0256-2026·2026-01-21

    Topical Corticosteroid Drug Recalled for Out-of-Specification Impurity

    Sun Pharmaceutical is recalling Fluocinolone Acetonide Solution topical solution distributed nationwide due to manufacturing quality issues. Testing found an impurity level that exceeded specifications.

    Product
    FLUOCINOLONE ACETONIDE — FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0144-2026·2025-11-05

    Prescription Lisdexamfetamine Dimesylate Capsules Recalled for Failed Dissolution Testing

    Sun Pharmaceutical Industries is recalling specific lots of Lisdexamfetamine Dimesylate capsules because they failed dissolution testing during stability analysis. The affected lots may not dissolve properly to deliver the intended dose.

    Product
    LISDEXAMFETAMINE DIMESYLATE — LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0149-2026·2025-11-05

    Lisdexamfetamine Dimesylate Capsules Recalled Due to Failed Dissolution Specifications

    Sun Pharmaceutical is recalling Lisdexamfetamine Dimesylate 60 mg capsules (Lots AD48711 and AD50896) distributed nationwide due to failed dissolution specifications identified in stability testing. The affected capsules may not dissolve properly.

    Product
    LISDEXAMFETAMINE DIMESYLATE — LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0146-2026·2025-11-05

    Lisdexamfetamine Dimesylate Capsules Recalled for Failed Dissolution Specifications

    Sun Pharmaceutical recalls Lisdexamfetamine Dimesylate 30 mg capsules nationwide due to failed dissolution test results during 12-month stability testing. No illnesses have been reported.

    Product
    LISDEXAMFETAMINE DIMESYLATE — LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0148-2026·2025-11-05

    Lisdexamfetamine Dimesylate Capsules Recalled for Failed Dissolution Specifications

    Sun Pharmaceutical is recalling specific lots of Lisdexamfetamine Dimesylate Capsules 50 mg due to failed dissolution specifications that may affect medication effectiveness.

    Product
    LISDEXAMFETAMINE DIMESYLATE — LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0145-2026·2025-11-05

    Prescription drug Lisdexamfetamine recall due to failed dissolution specifications

    Sun Pharmaceutical Industries is recalling Lisdexamfetamine Dimesylate capsules nationwide due to failed dissolution specifications discovered during stability testing. No illnesses have been reported.

    Product
    LISDEXAMFETAMINE DIMESYLATE — LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0658-2025·2025-09-24

    Prescription Drug Recall: Technetium Tc99m Mertiatide Kits - Dissolution Specification Failure

    Sun Pharmaceutical recalls 1870 kits of Technetium Tc99m Mertiatide due to failed dissolution specifications in a component used for production. The affected lot was distributed nationwide.

    Product
    KIT FOR THE PREPARATION OF TECHNETIUM TC99M MERTIATIDE — KIT FOR THE PREPARATION OF TECHNETIUM TC99M MERTIATIDE (BETIATIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0574-2025·2025-08-13

    Spironolactone Tablets Recalled for Aluminum Contamination

    Sun Pharmaceutical is recalling Spironolactone tablets nationwide due to the presence of aluminum, a foreign substance. Patients should consult their healthcare provider before making changes to treatment.

    Product
    SPIRONOLACTONE — SPIRONOLACTONE (SPIRONOLACTONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0516-2025·2025-07-23

    Lisdexamfetamine Dimesylate Capsules Recalled Due to Dissolution Specification Failure

    Sun Pharmaceutical is recalling 5,448 bottles of Lisdexamfetamine Dimesylate 60mg capsules due to failed dissolution specifications detected during long-term stability testing. No illnesses have been reported.

    Product
    LISDEXAMFETAMINE DIMESYLATE — LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0311-2025·2025-04-16

    Prescription Gabapentin 300 mg Capsules Recalled for Cross Contamination

    Sun Pharmaceutical is recalling 12,876 bottles of Gabapentin 300 mg capsules distributed nationwide due to cross contamination. The recall is voluntary and ongoing.

    Product
    GABAPENTIN — GABAPENTIN (GABAPENTIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0249-2025·2025-03-12

    Morphine Sulfate Tablets Recalled Over Failed Dissolution Specifications

    Sun Pharmaceutical is recalling Morphine Sulfate Extended-Release 100 mg tablets (lot AD16615) because they fail dissolution specifications, potentially resulting in unpredictable drug delivery.

    Product
    MORPHINE SULFATE — MORPHINE SULFATE (MORPHINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0597-2024·2024-07-24

    FDA Recalls Nitrofurantoin Capsules Due to Failed Dissolution Specifications

    Sun Pharmaceutical recalls Nitrofurantoin Capsules (100 mg) due to failed dissolution, affecting medication effectiveness. The recall involves 5,752 bottles nationwide in lots 231067 and 231069.

    Product
    NITROFURANTION — NITROFURANTION (NITROFURANTION)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0582-2024·2024-07-10

    Sun Pharmaceutical Recalls Decitabine Injection for Microbial Contamination

    Sun Pharmaceutical is recalling Decitabine for Injection (lot HAD2964A, 2,088 vials) for a Current Good Manufacturing Practice deviation. The Total Aerobic Microbial Count test on unfiltered bulk was out of specification; the product was distributed nationwide.

    Product
    Decitabine for Injection 50mg per vial, For intravenous infusion only Cytotoxic Agent, Sterile, Rx Only, Single-Dose Vial, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0502-2024·2024-05-29

    Prescription eye drops recalled for particulate matter contamination

    Sun Pharmaceutical recalls Xelpros latanoprost eye drops (Lot HAD3383A) due to particulate matter contamination detected during release testing. Affected bottles were distributed in Texas and Pennsylvania.

    Product
    XELPROS — XELPROS (LATANOPROST)
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-0493-2024·2024-05-15

    Prescription antifungal injection product recalled for out-of-specification assay

    Sun Pharmaceutical is recalling Amphotericin B for Injection (50 mg vials) due to out-of-specification assay results. The recall affects 11,016 vials with lot numbers BAE0055A, BAE0056A, and BAE0068A distributed nationwide.

    Product
    AMPHOTERICIN B — AMPHOTERICIN B (AMPHOTERICIN B)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0368-2024·2024-03-20

    Prescription drug Febuxostat recalled due to manufacturing contamination

    Sun Pharmaceutical is recalling 47,520 bottles of Febuxostat 40mg tablets nationwide due to microbial contamination found in manufacturing equipment. The FDA classified this as a Class II recall; no illnesses have been reported.

    Product
    FEBUXOSTAT — FEBUXOSTAT (FEBUXOSTAT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0369-2024·2024-03-20

    Febuxostat tablets recalled due to microbial contamination in manufacturing

    Sun Pharmaceutical is recalling 7,488 bottles of Febuxostat 80mg tablets nationwide due to microbial contamination found in manufacturing equipment. No illnesses have been reported.

    Product
    FEBUXOSTAT — FEBUXOSTAT (FEBUXOSTAT)
    Category
    Drug
    Distribution
    Distributed nationwide