Food, drugs, devices › SUN PHARMACEUTICAL INDUSTRIES INC

Drug recall: Nystatin Cream, USP, 15 g per tube, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761; Di

FDA enforcement event 99876 · Unclassified · initiated 14 Sep 2026 · status Ongoing

DrugVoluntary: Firm initiated1 product recordPrinceton, NJ

SUN PHARMACEUTICAL INDUSTRIES INC (Princeton, NJ) initiated this drug recall on 14 Sep 2026; FDA lists 1 product record under event 99876.

FDA has not yet assigned a class to this event; 234 drug events were initiated in 2026.

Status: Ongoing. Initiation: voluntary: firm initiated. SUN PHARMACEUTICAL INDUSTRIES INC has 94 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ.

Reason for recall

"Failed Stability Specifications"

Distribution

"U.S. Nationwide."

Product records

Recall number	Product	Quantity	Class	Status	Report date
N/A	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	N/A	Unclassified	Ongoing	23 Sep 2026

Context

0%of 2026 drug events are unclassified234 events that year

1product record in this eventfirm median: 1

94events on this register for the firm

Other enforcement events for SUN PHARMACEUTICAL INDUSTRIES INC

Initiated	Product (first record)	Type	Class	Records
3 Aug 2026	Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd., Ha	Drug	Class II	1
17 Jun 2026	Perampanel CIII Tablets, 6mg, Rx only, 30 Tablets, Mfd.by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 262476	Drug	Class II	1
1 Jun 2026	Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine, 150 Tablets per bottle, Distributed by: Ohm Laboratories,	Drug	Class III	1
29 May 2026	Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules (5 Single-Dose Ampules per pouch, 6 pou	Drug	Class II	1
22 May 2026	Xyvona (levorphanol tartrate tablets), 2mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories Inc	Drug	Class II	2
12 May 2026	DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL single-dose vials, Sterile, Rx only, Manufacture	Drug	Class I	1
25 Mar 2026	Fluocinonide, USP, 0.05% Cream, 15g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1,	Drug	Class II	3
27 Jan 2026	Diclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L	Drug	Class II	1
30 Dec 2025	Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist. by: Taro Pharmaceuticals Inc.	Drug	Class III	1
26 Nov 2025	Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applicator bottle, Rx only, Mfd. by: Taro Pharmace	Drug	Class III	1

All 94 events for SUN PHARMACEUTICAL INDUSTRIES INC

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Failed Stability Specifications"

What does Class unassigned mean?

FDA assigns a class after evaluating the hazard; this event has not been classified in the current file.

Where was the product distributed?

FDA's distribution pattern field reads: "U.S. Nationwide."

Is the recall still ongoing?

FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.