Sun Pharmaceutical Industries, Inc. recalls

22 recalls on record · latest: May 13, 2026

Official U.S. recall history for Sun Pharmaceutical Industries, Inc., compiled from official government records.

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DOXOrubicin Hydrochloride Liposome Injection 50mg/ recalled over foreign material

May 13, 2026 · Drug & medication recalls Presence of glass particles — Potential Foreign Material

SUN PHARMACEUTICAL INDUSTRIES INC recalls Fluocinonide, USP, 0.05% Cream, 15g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1…

March 25, 2026 · Drug & medication recalls Moderate risk Failed Viscosity Specifications: Out of Specification results, above the specif…

SUN PHARMACEUTICAL INDUSTRIES INC recalls Fluocinonide, USP, 0.05% Cream, 60g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1…

March 25, 2026 · Drug & medication recalls Moderate risk Failed Viscosity Specifications: Out of Specification results, above the specif…

SUN PHARMACEUTICAL INDUSTRIES INC recalls Fluocinonide, USP, 0.05% Cream, 30g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1…

March 25, 2026 · Drug & medication recalls Moderate risk Failed Viscosity Specifications: Out of Specification results, above the specif…

SUN PHARMACEUTICAL INDUSTRIES INC recalls Diclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada…

January 27, 2026 · Drug & medication recalls Moderate risk Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower tha…

SUN PHARMACEUTICAL INDUSTRIES INC recalls Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist. by: Taro Pharmaceuticals Inc…

December 30, 2025 · Drug & medication recalls Failed Impurities/Degradation Specifications: Out of specification result was o…

SUN PHARMACEUTICAL INDUSTRIES INC recalls Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applicator bottle, Rx only, Mfd. by: Taro Pharmac…

November 26, 2025 · Drug & medication recalls Failed Impurities/Degradation: Out of Specification results for Total Impuritie…

SUN PHARMACEUTICAL INDUSTRIES INC recalls Lisdexamfetamine Dimesylate Capsules, 30 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Bru…

October 28, 2025 · Drug & medication recalls Moderate risk Failed Dissolution Specifications: An out of specification results observed in…

SUN PHARMACEUTICAL INDUSTRIES INC recalls Lisdexamfetamine Dimesylate Capsules, 40 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Bru…

October 28, 2025 · Drug & medication recalls Moderate risk Failed Dissolution Specifications: An out of specification results observed in…

SUN PHARMACEUTICAL INDUSTRIES INC recalls Lisdexamfetamine Dimesylate Capsules, 10 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Bru…

October 28, 2025 · Drug & medication recalls Moderate risk Failed Dissolution Specifications: An out of specification results observed in…

SUN PHARMACEUTICAL INDUSTRIES INC recalls Lisdexamfetamine Dimesylate Capsules, 20 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Bru…

October 28, 2025 · Drug & medication recalls Moderate risk Failed Dissolution Specifications: An out of specification results observed in…

SUN PHARMACEUTICAL INDUSTRIES INC recalls Lisdexamfetamine Dimesylate Capsules, 70 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Bru…

October 28, 2025 · Drug & medication recalls Moderate risk Failed Dissolution Specifications: An out of specification results observed in…

SUN PHARMACEUTICAL INDUSTRIES INC recalls Lisdexamfetamine Dimesylate Capsules, 50 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Bru…

October 28, 2025 · Drug & medication recalls Moderate risk Failed Dissolution Specifications: An out of specification results observed in…

SUN PHARMACEUTICAL INDUSTRIES INC recalls Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Bru…

October 28, 2025 · Drug & medication recalls Moderate risk Failed Dissolution Specifications: An out of specification results observed in…

SUN PHARMACEUTICAL INDUSTRIES INC recalls Kit for the Preparation of Technetium Tc 99m Mertiatide, Rx Only, Manufactured by: Sun Pharmaceutical Industries, Inc.…

September 3, 2025 · Drug & medication recalls Moderate risk Failed Dissolution Specifications-Out of Specification (OOS) observation for su…

SUN PHARMACEUTICAL INDUSTRIES INC recalls Spironolactone Tablets, USP, 25 mg, 100-count bottle, Rx only, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St, Phil…

August 5, 2025 · Drug & medication recalls Moderate risk Presence of foreign substance: identified as aluminum.

SUN PHARMACEUTICAL INDUSTRIES INC recalls Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottles, Rx only, Manufactured by: OHM Laboratories, New Br…

June 16, 2025 · Drug & medication recalls Moderate risk Failed Dissolution Specifications: An out of specification results observed in…

SUN PHARMACEUTICAL INDUSTRIES INC recalls Gabapentin Capsules, USP 300 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-138-05; b) 1000-count bottles, ND…

March 4, 2025 · Drug & medication recalls Cross Contamination

SUN PHARMACEUTICAL INDUSTRIES INC recalls Gabapentin Capsules, USP 400 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-139-05; b) 1000-count bottles, ND…

March 4, 2025 · Drug & medication recalls Cross Contamination

SUN PHARMACEUTICAL INDUSTRIES INC recalls Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Ohm Laboratories Inc.,…

February 6, 2025 · Drug & medication recalls Moderate risk Failed Dissolution Specifications

SUN PHARMACEUTICAL INDUSTRIES INC recalls Nitrofurantoin Capsules, USP (Macrocrystals), 100 mg, Rx Only, 100 capsules per bottle, Manufactured by: Sidmak Laborat…

July 9, 2024 · Drug & medication recalls Moderate risk Failed Dissolution Specifications

Decitabine for Injection 50mg per vial recalled over manufacturing violations

July 2, 2024 · Drug & medication recalls Moderate risk CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC)…