The Recall Desk

Manufacturer

Sun Pharmaceutical Industries, Inc.

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

What the numbers show

Total
137
Critical
1
Severe
11
Most recent
2026-08-26

Of the 137 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.

1–25 of 137

  • LowFDA (Drugs)·D-0654-2026·2026-07-08

    Fexofenadine Hydrochloride Tablets 180 mg Recalled for Impurities

    SUN PHARMACEUTICAL INDUSTRIES INC is recalling Fexofenadine Hydrochloride Tablets, USP 180 mg distributed nationwide because the product failed impurities and degradation specifications. The recall affects approximately 9,048 bottles distributed across the United States.

    Product
    Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine, 150 Tablets per bottle, Distributed by: Ohm Laboratories, Inc., New Brunswick, NJ 08901. NDC 66336-561-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0628-2026·2026-07-01

    Perampanel Prescription Tablets Recalled for Labeling Mix-up

    Sun Pharmaceutical is recalling Perampanel 6 mg tablets due to labeling mix-up where 10 mg tablets were found in bottles labeled as 6 mg. Patients should verify their bottles with their pharmacy or physician.

    Product
    PERAMPANEL — PERAMPANEL (PERAMPANEL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0580-2026·2026-06-17

    Doxorubicin liposome injection vials contain glass particulate matter

    Doxorubicin Hydrochloride Liposome Injection, 50 mg/25 mL single-dose vials, is being recalled because of particulate matter identified as glass. 675 vials are affected.

    Product
    DOXORUBICIN HYDROCHLORIDE — DOXORUBICIN HYDROCHLORIDE (DOXORUBICIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0607-2026·2026-06-17

    Budesonide inhalation ampules contain black and brown specks and particles

    Budesonide Inhalation Suspension, 1 mg/2 mL single-dose ampules from Sun Pharmaceutical, is being recalled after a quality complaint of black or brown specs and particles in the solution.

    Product
    BUDESONIDE — BUDESONIDE (BUDESONIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0598-2026·2026-06-10

    Xyvona levorphanol tablets recalled after FDA denied the proprietary name

    Xyvona levorphanol tartrate tablets, 2 mg, are being recalled following FDA's denial of marketing the product under the proprietary name Xyvona.

    Product
    Xyvona (levorphanol tartrate tablets), 2mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by: Fort Bio-Pharma, LLC., Las Vegas, NV 89113, NDC 72245-762-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0599-2026·2026-06-10

    Xyvona 3 mg levorphanol tablets recalled after proprietary name denial

    Xyvona levorphanol tartrate tablets, 3 mg, are being recalled following FDA's denial of marketing the product under the proprietary name Xyvona.

    Product
    Xyvona (levorphanol tartrate tablets), 3mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by: Fort Bio-Pharma, LLC., Las Vegas, NV 89113, NDC 72245-058-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0477-2026·2026-04-22

    Taro fluocinonide cream 60 g tubes fail viscosity stability specifications

    Taro is recalling one lot of Fluocinonide 0.05% Cream in 60 g tubes after stability testing returned viscosity results above the specification limit. 2,640 tubes are affected.

    Product
    FLUOCINONIDE — FLUOCINONIDE (FLUOCINONIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0476-2026·2026-04-22

    Taro fluocinonide cream 30 g tubes fail viscosity stability specifications

    Taro is recalling one lot of Fluocinonide 0.05% Cream in 30 g tubes after stability testing returned viscosity results above the specification limit. 41,712 tubes are affected.

    Product
    FLUOCINONIDE — FLUOCINONIDE (FLUOCINONIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0342-2026·2026-02-11

    Diclofenac topical gel recalled after failing viscosity specifications

    Sun Pharmaceutical Industries is recalling a lot of Diclofenac Sodium Topical Gel, 3%, after an out of specification viscosity result slightly below the limit.

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

    Fluocinolone topical solution recalled after failing an impurity specification

    Sun Pharmaceutical Industries is recalling 24,624 bottles of Fluocinolone Acetonide Topical Solution 0.01% after an out of specification result for a known impurity.

    Product
    FLUOCINOLONE ACETONIDE — FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0147-2026·2025-11-05

    Lisdexamfetamine capsules recalled after failing dissolution at twelve month stability

    Sun Pharmaceutical Industries is recalling two lots of Lisdexamfetamine Dimesylate Capsules 40 mg after an out-of-specification dissolution result at the 12-month stability station.

    Product
    LISDEXAMFETAMINE DIMESYLATE — LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0150-2026·2025-11-05

    Lisdexamfetamine 70 mg capsules recalled after failing dissolution at twelve month stability

    Sun Pharmaceutical Industries is recalling two lots of Lisdexamfetamine Dimesylate Capsules 70 mg after an out-of-specification dissolution result at the 12-month stability station.

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

    Lisdexamfetamine 30 mg capsules recalled after failing dissolution at twelve month stability

    Sun Pharmaceutical Industries is recalling two lots of Lisdexamfetamine Dimesylate Capsules 30 mg after an out-of-specification dissolution result at the 12-month stability station.

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

    Lisdexamfetamine 20 mg capsules recalled after failing dissolution at twelve month stability

    Sun Pharmaceutical Industries is recalling two lots of Lisdexamfetamine Dimesylate Capsules 20 mg after an out-of-specification dissolution result at the 12-month stability station.

    Product
    LISDEXAMFETAMINE DIMESYLATE — LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0144-2026·2025-11-05

    Lisdexamfetamine 10 mg capsules recalled after failing dissolution at twelve month stability

    Sun Pharmaceutical Industries is recalling two lots of Lisdexamfetamine Dimesylate Capsules 10 mg after an out-of-specification dissolution result at the 12-month stability station.

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

    Lisdexamfetamine 60 mg capsules recalled after failing dissolution at twelve month stability

    Sun Pharmaceutical Industries is recalling two lots of Lisdexamfetamine Dimesylate Capsules 60 mg after an out-of-specification dissolution result at the 12-month stability station.

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

    Lisdexamfetamine 50 mg capsules recalled after failing dissolution at twelve month stability

    Sun Pharmaceutical Industries is recalling two lots of Lisdexamfetamine Dimesylate Capsules 50 mg after an out-of-specification dissolution result at the 12-month stability station.

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

    Technetium mertiatide kits recalled after out-of-specification sulphate in a raw material

    Sun Pharmaceutical's Kit for the Preparation of Technetium Tc 99m Mertiatide, lot AD70995, is recalled after an out-of-specification result for sulphate in the sodium tartrate dihydrate used in production. 1,870 kits are affected.

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

    Spironolactone 25 mg tablets recalled after aluminum was found in product

    Spironolactone Tablets USP 25 mg are being recalled because of the presence of a foreign substance identified as aluminum. 11,328 bottles are affected.

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

    Lisdexamfetamine 60 mg capsules failed dissolution testing at nine month stability

    Lisdexamfetamine Dimesylate Capsules 60 mg are being recalled because an out of specification result was observed in dissolution testing at the nine month long term stability station. 5,448 bottles affected.

    Product
    LISDEXAMFETAMINE DIMESYLATE — LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0312-2025·2025-04-16

    Gabapentin Capsules 400 mg Recalled for Cross Contamination

    Sun Pharmaceutical Industries Inc. is recalling Gabapentin Capsules 400 mg due to cross contamination. The recall affects 852 bottles distributed nationwide.

    Product
    GABAPENTIN — GABAPENTIN (GABAPENTIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0311-2025·2025-04-16

    Gabapentin Capsules Recalled for Cross Contamination

    Sun Pharmaceutical Industries is recalling Gabapentin Capsules, USP 300 mg, due to cross contamination. The recall affects approximately 12,876 bottles distributed nationwide.

    Product
    GABAPENTIN — GABAPENTIN (GABAPENTIN)
    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.