SUN PHARMACEUTICAL INDUSTRIES INC Recalls

10 recalls on record in the United States

drugs: 10
drugs Class II
2026-04-22

SUN PHARMACEUTICAL INDUSTRIES INC recalls Fluocinonide, USP, 0.05% Cream, 30g tube, Rx only, Mfd by: T

Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.

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drugs Class II
2026-04-22

SUN PHARMACEUTICAL INDUSTRIES INC recalls Fluocinonide, USP, 0.05% Cream, 60g tube, Rx only, Mfd by: T

Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.

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drugs Class II
2026-04-22

SUN PHARMACEUTICAL INDUSTRIES INC recalls Fluocinonide, USP, 0.05% Cream, 15g tube, Rx only, Mfd by: T

Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.

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drugs Class II
2026-06-17

SUN PHARMACEUTICAL INDUSTRIES INC recalls Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile

Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution

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drugs Class I
2026-06-17

SUN PHARMACEUTICAL INDUSTRIES INC recalls DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg

Presence of Particulate matter: Particulate matter identified as glass.

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drugs Class II
2026-06-10

SUN PHARMACEUTICAL INDUSTRIES INC recalls Xyvona (levorphanol tartrate tablets), 2mg, 100 Tablets, Rx

Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona

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drugs Class II
2026-06-10

SUN PHARMACEUTICAL INDUSTRIES INC recalls Xyvona (levorphanol tartrate tablets), 3mg, 100 Tablets, Rx

Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona

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drugs Class II
2026-07-01

SUN PHARMACEUTICAL INDUSTRIES INC recalls Perampanel CIII Tablets, 6mg, Rx only, 30 Tablets, Mfd.by: T

Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.

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drugs Class III
2026-07-08

SUN PHARMACEUTICAL INDUSTRIES INC recalls Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamin

Failed Impurities/Degradation Specifications

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drugs Class II
2026-08-26

SUN PHARMACEUTICAL INDUSTRIES INC recalls Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx on

CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing

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