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SUN PHARMACEUTICAL INDUSTRIES

6 recalls on record · Last recall: Sep 14, 2026

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Records, not a safety rating.

Recall counts do not account for sales volume, exposure or differences in reporting. Agency records can overlap. A low count does not establish that a brand or product is safe.

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Severity Breakdown

Class I — Serious
1
Class II — Moderate
3
Class III — Low Risk
1
Unclassified
1

Categories

MEDICATION

Recall Timeline

FDASep 14, 2026

SUN PHARMACEUTICAL INDUSTRIES — Failed Stability Specifications

Nystatin Cream, USP, 15 g per tube, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761; Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. NDC: 51672-1289-1 Failed Stability Specifications

Class IIFDAAug 3, 2026

SUN PHARMACEUTICAL INDUSTRIES — CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing

Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC 51672-4005-3. CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing

Class IIFDAJun 17, 2026

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

Perampanel CIII Tablets, 6mg, Rx only, 30 Tablets, Mfd.by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 51672-4206-6 Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.

Class IIIFDAJun 1, 2026

SUN PHARMACEUTICAL INDUSTRIES — Failed Impurities/Degradation Specifications

Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine, 150 Tablets per bottle, Distributed by: Ohm Laboratories, Inc., New Brunswick, NJ 08901. NDC 66336-561-30 Failed Impurities/Degradation Specifications

Class IIFDAMay 29, 2026

SUN PHARMACEUTICAL INDUSTRIES — 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

Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules (5 Single-Dose Ampules per pouch, 6 pouches per carton, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Baska Ujeti Road, Ujeti Halol-289350, Gujarat, India, NDC 47335-633-49. 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

Class IFDAMay 12, 2026

SUN PHARMACEUTICAL INDUSTRIES — Presence of Particulate matter: Particulate matter identified as glass.

DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL single-dose vials, Sterile, Rx only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol, Gujarat, India, NDC 72603-200-01. Presence of Particulate matter: Particulate matter identified as glass.

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