Food, drugs, devices › SUN PHARMACEUTICAL INDUSTRIES INC

Drug recall: Oxcarbazepine Tablets 600mg, packaged in a) 100- count bottles (NDC 62756-185-88), b) 500-count bottles (NDC 62756-185-1

FDA enforcement event 91311 · Class II · initiated 1 Dec 2022 · status Terminated · terminated 13 Sep 2023

DrugVoluntary: Firm initiated1 product recordPrinceton, NJ

SUN PHARMACEUTICAL INDUSTRIES INC (Princeton, NJ) initiated this drug recall on 1 Dec 2022; FDA lists 1 product record under event 91311, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 65% of the 325 drug enforcement events initiated in 2022 carry the same class.

Status: Terminated, terminated 13 Sep 2023. 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

"Presence of foreign substance"

Distribution

"Nationwide within the United States"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-0085-2023	Oxcarbazepine Tablets 600mg, packaged in a) 100- count bottles (NDC 62756-185-88), b) 500-count bottles (NDC 62756-185-13), c)1000-count bottles (NDC 62756-185-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Halol-Baroda…	Lot HAC1474A: 4296 Bottles, Lot HAC1474B: 145 Bottles, Lot HAC1503A: 2124 Bottles	Class II	Terminated	28 Dec 2022

Context

65%of 2022 drug events are Class II325 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
14 Sep 2026	Nystatin Cream, USP, 15 g per tube, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761; Di	Drug	Unclassified	1
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

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: "Presence of foreign substance"

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "Nationwide within the United States"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 13 Sep 2023. "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.