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.

51–75 of 79

  • ModerateFDA (Drugs)·D-0529-2023·2023-04-19

    Drug Injection Recall: Norepinephrine Bitartrate Impurity Above Specification

    Sun Pharmaceutical is recalling Norepinephrine Bitartrate Injection due to a chemical impurity exceeding specification limits detected during routine monitoring. The recall affects 16,450 vials distributed nationwide.

    Product
    NOREPINEPHRINE BITARTRATE — NOREPINEPHRINE BITARTRATE (NOREPINEPHRINE BITARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0474-2023·2023-03-29

    Dofetilide Capsules Recalled for Failed Content Uniformity Specifications

    Sun Pharmaceutical is recalling 1,920 bottles of Dofetilide Capsules (500 mcg) nationwide due to failed content uniformity specifications, meaning the capsules do not contain uniform amounts of active ingredient.

    Product
    Dofetilide Capsules, 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India, NDC 47335-0063-86
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0262-2023·2023-02-08

    Diltiazem Hydrochloride extended-release capsules recalled due to failed quality specifications

    Sun Pharmaceutical is recalling Diltiazem Hydrochloride Extended-Release Capsules (360 mg) due to failed impurity specifications and dissolution testing found during FDA laboratory evaluation. The recall affects five lot numbers distributed nationwide.

    Product
    DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0085-2023·2022-12-28

    Oxcarbazepine 600mg tablets recalled for foreign substance contamination

    Sun Pharmaceutical is recalling three lots of Oxcarbazepine 600mg tablets due to the presence of foreign substances. The affected medication was distributed nationwide.

    Product
    OXCARBAZEPINE — OXCARBAZEPINE (OXCARBAZEPINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0068-2023·2022-11-30

    Pantoprazole Sodium Oral Suspension Recalled for Discoloration

    Sun Pharmaceutical recalls Pantoprazole Sodium oral suspension nationwide due to product discoloration. Lot MHC1317A with approximately 14,064 units was distributed in the USA.

    Product
    PANTOPRAZOLE SODIUM — PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0024-2023·2022-11-09

    Buprenorphine and Naloxone Sublingual Tablets Recalled for Foreign Substance

    Sun Pharmaceutical is recalling buprenorphine and naloxone sublingual tablets (8 mg/2 mg) due to a foreign substance. Affected lots DNC1129A and DNC1740A were distributed nationwide.

    Product
    BUPRENORPHINE AND NALOXONE — BUPRENORPHINE AND NALOXONE (BUPRENORPHINE AND NALOXONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0005-2023·2022-10-05

    Prescription Drug Esomeprazole Out of Specification for Potency

    Sun Pharmaceutical is recalling Esomeprazole Magnesium capsules nationwide because the drug potency exceeds the specified level at the 12-month timepoint.

    Product
    ESOMEPRAZOLE MAGNESIUM — ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0004-2023·2022-10-05

    Esomeprazole Magnesium Capsules Recalled for Out-of-Specification Potency

    Sun Pharmaceutical is recalling Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg nationwide due to superpotency findings. Lot AC14299 (expiration 12/2022) tested out of specification for drug assay at the 12-month stability timepoint.

    Product
    ESOMEPRAZOLE MAGNESIUM — ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1291-2022·2022-08-03

    FDA Recalls Divalproex Sodium Tablets for Failed Dissolution Specifications

    Sun Pharmaceutical recalls Divalproex Sodium delayed-release tablets due to failed dissolution specifications discovered during stability testing. The tablets may not dissolve as intended.

    Product
    DIVALPROEX SODIUM — DIVALPROEX SODIUM (DIVALPROEX SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1190-2022·2022-07-20

    Testosterone Cypionate Injection Recalled for Water Leakage in Manufacturing

    Sun Pharmaceutical recalls 50,860 vials of Testosterone Cypionate Injection due to water leakage during manufacturing that could affect product sterility. The firm-initiated recall was reported in July 2022 and affects nationwide distribution.

    Product
    TESTOSTERONE CYPIONATE — TESTOSTERONE CYPIONATE (TESTOSTERONE CYPIONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1176-2022·2022-07-13

    Testosterone Cypionate Injectable Drug Recalled for Manufacturing Deviations

    Sun Pharmaceutical is recalling 27 vials of Testosterone Cypionate Injection (200 mg/mL) due to manufacturing deviations caused by abnormal machinery appearance. The recall affects multiple lot numbers distributed nationwide.

    Product
    TESTOSTERONE CYPIONATE — TESTOSTERONE CYPIONATE (TESTOSTERONE CYPIONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1155-2022·2022-06-29

    Clonazepam Tablets Recalled Due to Manufacturing Defect

    Sun Pharmaceutical is recalling Clonazepam Orally Disintegrating Tablets (0.125mg) due to manufacturing defects where oversized tablets were found. The affected lot (MHC1430A, exp. 09/2023) was distributed nationwide.

    Product
    Clonazepam Orally Disintegrating Tablets, USP, 0.125mg, Rx Only, 60 Tablets, Mfd. by: Sun Pharmaceutical Industries Ltd. Mumbai, India, Dist. by: Sun Pharmaceutical Industries In., Cranbury, NJ 08512, NDC 57664-783-68, packaged in bottles.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1153-2022·2022-06-29

    Testosterone Cypionate Injectable Recalled for Manufacturing Quality Issues

    Sun Pharmaceutical recalls 97,450 vials of Testosterone Cypionate Injection nationwide due to manufacturing deviations that could cause out-of-specification impurities.

    Product
    TESTOSTERONE CYPIONATE — TESTOSTERONE CYPIONATE (TESTOSTERONE CYPIONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1154-2022·2022-06-29

    Testosterone Cypionate Injectable Recalled Due to Manufacturing Sterility Deviation

    Sun Pharmaceutical is recalling approximately 47,500 vials of Testosterone Cypionate Injection due to a manufacturing deviation that may have affected product sterility.

    Product
    TESTOSTERONE CYPIONATE — TESTOSTERONE CYPIONATE (TESTOSTERONE CYPIONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1146-2022·2022-06-22

    Medroxyprogesterone acetate injectable suspension recalled for lack of sterility assurance

    Sun Pharmaceutical is recalling medroxyprogesterone acetate injectable suspension (150 mg/mL) nationwide due to lack of assurance of sterility. Affected lots contain vials with expiration dates from December 2022 through September 2023.

    Product
    medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Single-Dose Vial, 150 mg/mL, Rx only, Manufactured for: Northstart Rx LLC, Memphis, TN, 38141, Manufactured by: Sun Pharmaceutical Industries Ltd., Halol Baroda Highway, Halol-389 350, Gujarat India , NDC 16714-981-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1145-2022·2022-06-22

    Medroxyprogesterone Acetate Injectable Suspension Recalled for Sterility Concerns

    Sun Pharmaceutical is recalling 4,625 syringes of Medroxyprogesterone Acetate Injectable Suspension (Lot HAC1951A) due to lack of assurance of sterility. The affected medication was distributed nationwide.

    Product
    MEDROXYPROGESTERONE ACETATE — MEDROXYPROGESTERONE ACETATE (MEDROXYPROGESTERONE ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1143-2022·2022-06-22

    Prefilled Syringes of Medroxyprogesterone Acetate Recalled for Lack of Sterility Assurance

    Afaxys Pharma is recalling 79,339 prefilled syringes of medroxyprogesterone acetate because the manufacturer could not assure sterility. The syringes were distributed nationwide.

    Product
    medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe, 150 mg/mL, Rx only, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India Distributed by: Afaxys Pharma, LLC, Charleston, SC, 29403, USA, Product of
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1144-2022·2022-06-22

    Medroxyprogesterone Acetate Injectable Suspension Recalled for Sterility Assurance Failure

    Sun Pharmaceutical is recalling medroxyprogesterone acetate injectable suspension due to lack of assurance of sterility. The recall affects approximately 57,997 prefilled syringes distributed nationwide.

    Product
    medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe, 150 mg/mL, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 16714-999-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1147-2022·2022-06-22

    Medroxyprogesterone acetate injectable vials recalled for lack of sterility assurance

    Sun Pharmaceutical is recalling 26,892 vials of medroxyprogesterone acetate injectable suspension (150 mg/mL) distributed nationwide due to lack of assurance of sterility. The affected lots expire between January and June 2023.

    Product
    medroxyPROGESTERone Acetate Injectable Suspension, USP, 25 x 1 mL Single-Dose Vial, 150 mg/mL, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Halol Baroda Highway, Halol-389 350, Gujarat India
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0857-2022·2022-05-18

    Bupropion Hydrochloride 150 mg Extended-Release Tablets Recalled for Activated Carbon Contamination

    Sun Pharmaceutical is recalling Bupropion Hydrochloride 150 mg extended-release tablets distributed nationwide due to activated carbon particles from desiccant canisters found in bottles. No illnesses have been reported.

    Product
    BUPROPION HYDROCHLORIDE — BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0858-2022·2022-05-18

    Bupropion Extended-Release Tablets Recalled for Activated Carbon Contamination

    Sun Pharmaceutical is recalling Bupropion Extended-Release 200mg tablets after customers found activated carbon particles inside bottles from the desiccant canister.

    Product
    BUPROPION HYDROCHLORIDE — BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0770-2022·2022-04-13

    Ophthalmic drug recalled for subpotency and particulate matter

    Sun Pharmaceutical recalls CEQUA cyclosporine ophthalmic solution nationwide due to low assay results and particulate matter found in specific lots.

    Product
    CEQUA — CEQUA (CYCLOSPORINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0578-2022·2022-02-23

    Chlorthalidone Tablets Recalled for Foreign Matter Contamination

    Sun Pharmaceutical is recalling Chlorthalidone Tablets USP 25 mg (Lot #P0602, expiration 03/2023) due to stainless steel microscopic wear particles, punch lubricant oil, and silicone particles from the dust cup found in the product.

    Product
    CHLORTHALIDONE — CHLORTHALIDONE (CHLORTHALIDONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0361-2022·2022-01-12

    Pregabalin Capsules Recalled for Out-of-Specification Manufacturing Defects

    Sun Pharmaceutical Industries is recalling Pregabalin 50 mg capsules due to out-of-specification results in particle size distribution and bulk density of the active pharmaceutical ingredient.

    Product
    PREGABALIN — PREGABALIN (PREGABALIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0230-2022·2021-11-17

    Tadalafil Tablets Recalled for Incorrect Product Formulation

    Sun Pharmaceutical Industries is recalling Tadalafil 5 mg tablets (Lot # DNC1127A) because an incorrect grade of Crospovidone was used during manufacturing. The product was distributed to one distributor who may have further distributed it nationwide.

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