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.

26–50 of 79

  • HighFDA (Drugs)·D-0350-2024·2024-03-06

    Mesalamine extended-release capsules recalled due to dissolution failure

    Sun Pharmaceutical is recalling Mesalamine extended-release capsules due to failed dissolution specifications. The affected capsules may not dissolve and release medication properly.

    Product
    MESALAMINE — MESALAMINE (MESALAMINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0272-2024·2024-01-31

    Zolpidem Tartrate Extended-Release Tablets Recalled for Manufacturing Contamination

    SUN PHARMACEUTICAL INDUSTRIES is recalling 14,568 bottles of Zolpidem Tartrate Extended-Release 12.5mg tablets nationwide due to microbial contamination discovered in manufacturing equipment. Affected lot: DNE0893A (expires 07/31/2026).

    Product
    ZOLPIDEM TARTRATE — ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0273-2024·2024-01-31

    Fexofenadine Hydrochloride Antihistamine Tablets Recalled for Microbial Contamination

    Sun Pharmaceutical is recalling Fexofenadine Hydrochloride 180mg tablets due to microbial contamination discovered in manufacturing equipment. Approximately 54,504 bottles distributed nationwide are affected by this Class II recall.

    Product
    FEXOFENADINE HYDROCHLORIDE — FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0270-2024·2024-01-31

    Prescription Niacin Tablets Recalled for Microbial Contamination

    Sun Pharmaceutical is recalling Niacin Extended-Release Tablets nationwide due to microbial contamination found in manufacturing equipment. Affected lot numbers expire in June and July 2025.

    Product
    NIACIN — NIACIN (NIACIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0271-2024·2024-01-31

    Zolpidem Tartrate Tablets Recalled Due to Manufacturing Equipment Contamination

    Sun Pharmaceutical is recalling approximately 1220 bottles of Zolpidem Tartrate Extended-Release 6.25 mg tablets distributed nationwide due to microbial contamination detected in manufacturing equipment.

    Product
    ZOLPIDEM TARTRATE — ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0263-2024·2024-01-31

    Prescription Drug Cinacalcet Tablets Recalled for Manufacturing Contamination

    Sun Pharmaceutical is recalling 1,728 bottles of Cinacalcet Tablets 60mg due to microbial contamination found in manufacturing equipment. No illnesses have been reported.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0266-2024·2024-01-31

    Prescription Drug Recall: Lurasidone Hydrochloride Tablets for Microbial Contamination

    Sun Pharmaceutical is recalling 11,400 bottles of Lurasidone Hydrochloride 60mg tablets due to microbial contamination in manufacturing equipment. Patients taking this medication should contact their doctor or pharmacist.

    Product
    LURASIDONE HYDROCHLORIDE — LURASIDONE HYDROCHLORIDE (LURASIDONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0268-2024·2024-01-31

    Mesalamine Tablets Recalled for Manufacturing Equipment Microbial Contamination

    Sun Pharmaceutical recalls 10,690 bottles of Mesalamine tablets nationwide due to microbial contamination found in manufacturing equipment. Patients should contact their healthcare provider.

    Product
    MESALAMINE — MESALAMINE (MESALAMINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0150-2024·2023-12-20

    Liothyronine Sodium tablets recalled due to failed impurity and degradation specifications

    Sun Pharmaceutical is recalling 96,192 bottles of Liothyronine Sodium Tablets nationwide due to failed quality specifications for impurities and degradation. The affected lots were distributed in 100-count bottles.

    Product
    LIOTHYRONINE SODIUM — LIOTHYRONINE SODIUM (LIOTHYRONINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0137-2024·2023-12-13

    Bupropion Hydrochloride Extended-Release Tablets Recalled for Failed Dissolution

    Sun Pharmaceutical is recalling Bupropion Hydrochloride Extended-Release Tablets 200 mg due to failed dissolution specifications. The recall affects 2,016 bottles with lot HAD0630A distributed nationwide.

    Product
    BUPROPION HYDROCHLORIDE — BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0084-2024·2023-11-08

    Liothyronine Sodium Tablets Recalled for Failed Impurity Specifications

    Sun Pharmaceutical is recalling approximately 2,304 bottles of Liothyronine Sodium Tablets, USP, 25 mcg (lot DNC2204A) due to failed impurity and degradation specifications. The affected medication was distributed nationwide.

    Product
    LIOTHYRONINE SODIUM — LIOTHYRONINE SODIUM (LIOTHYRONINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0083-2024·2023-11-08

    Liothyronine Sodium Tablets Recalled for Failed Impurity and Degradation Specifications

    Sun Pharmaceutical is recalling 7,392 bottles of Liothyronine Sodium Tablets (Lot DND0058A) nationwide due to failed impurity and degradation specifications. Patients should contact their healthcare provider.

    Product
    LIOTHYRONINE SODIUM — LIOTHYRONINE SODIUM (LIOTHYRONINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0044-2024·2023-10-25

    Sun Pharmaceutical Bupropion Extended-Release Tablets Recalled for Failed Dissolution

    Sun Pharmaceutical is recalling Bupropion Hydrochloride Extended-Release Tablets (150 mg), lot HAD0360A, due to failed dissolution specifications. The 144 bottles were distributed nationwide and may not dissolve at the intended rate.

    Product
    BUPROPION HYDROCHLORIDE — BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1172-2023·2023-09-27

    Cequa cyclosporine ophthalmic solution recalled nationwide for subpotency

    Sun Pharmaceutical is recalling Cequa (cyclosporine) ophthalmic solution because certain lots contain less active ingredient than specified. Contact your doctor if using an affected product.

    Product
    CEQUA — CEQUA (CYCLOSPORINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1082-2023·2023-08-16

    Dofetilide Capsules Recalled Due to Out-of-Specification Content Uniformity

    Sun Pharmaceutical recalls Dofetilide 500 mcg capsules nationwide due to out-of-specification results in content uniformity testing. Affected lot DNE0217A with expiration 01/2025 may not meet pharmaceutical specifications.

    Product
    DOFETILIDE — DOFETILIDE (DOFETILIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0940-2023·2023-08-02

    Methylphenidate Hydrochloride Tablets Recalled Due to Metal Contamination

    Sun Pharmaceutical Industries is recalling 7,313 bottles of Methylphenidate Hydrochloride Tablets (20mg) due to metal embedded in some tablets. No illnesses have been reported.

    Product
    METHYLPHENIDATE HYDROCHLORIDE — METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0924-2023·2023-07-26

    Loteprednol Etabonate Eye Drops Recalled for Out-of-Specification Potency

    Sun Pharmaceutical recalls Loteprednol Etabonate eye drops due to out-of-specification unit dose content in certain lots. Affected bottles may contain incorrect potency levels.

    Product
    LOTEPREDNOL ETABONATE — LOTEPREDNOL ETABONATE (LOTEPREDNOL ETABONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0914-2023·2023-07-19

    FDA Recalls Tiagabine Hydrochloride Tablets Due to Impurity Specification Failures

    Sun Pharmaceutical is recalling Tiagabine Hydrochloride Tablets (2 mg) due to out-of-specification impurities detected during testing. The recall affects lot HAC3339A distributed nationwide.

    Product
    TIAGABINE HYDROCHLORIDE — TIAGABINE HYDROCHLORIDE (TIAGABINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0891-2023·2023-07-05

    Amphotericin B Liposome Injection Recalled for Subpotency Nationwide

    Sun Pharmaceutical recalled Amphotericin B Liposome for Injection due to subpotent drug content. The recall involved 12,960 vials distributed nationwide across the United States.

    Product
    Amphotericin B Liposome for Injection, 50mg/vial, Rx only, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by Sun Pharmaceutical Medicare Limited, Baska Ujeti Road, Ujeti, Halol-389350, Gujarat, India, NDC 62756-0233-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0869-2023·2023-06-14

    Buprenorphine Sublingual Tablets Recalled for Manufacturing Quality Deviations

    Sun Pharmaceutical recalls 12,336 bottles of Buprenorphine 8 mg sublingual tablets (Lot DND1515A) due to Good Manufacturing Practice deviations identified during manufacturing.

    Product
    BUPRENORPHINE — BUPRENORPHINE (BUPRENORPHINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0761-2023·2023-05-31

    Bupropion Hydrochloride Extended-Release Tablets Recalled for Failed Dissolution Specifications

    Sun Pharmaceutical is recalling nationwide certain lots of Bupropion Hydrochloride Extended-Release Tablets 150 mg because tablets from these lots failed to meet dissolution specifications during stability testing, potentially affecting drug effectiveness.

    Product
    BUPROPION HYDROCHLORIDE — BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide