The Recall Desk

Manufacturer

Sun Pharmaceutical Industries, Inc.

140 recalls in our database name Sun Pharmaceutical Industries, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
140
Critical
1
Severe
11
Most recent
2026-10-14

Of the 140 recalls from Sun Pharmaceutical Industries, Inc. we have scored against our rubric, 1 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 11 (8%) 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.

51–75 of 140

  • 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
  • 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
  • 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-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-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-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

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Sun Pharmaceutical

Indian multinational pharmaceutical company

Country
India
Founded
1983

Official website

Source: Wikidata (Q3291801), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.