--- title: "SUN PHARMACEUTICAL INDUSTRIES INC Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search SUN PHARMACEUTICAL INDUSTRIES INC recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/sun-pharmaceutical-industries-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # SUN PHARMACEUTICAL INDUSTRIES INC recall records **33** reported ongoing 87 records in this archive. Latest source date Sep 14, 2026. 1 published notices do not supply a closure status. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Sep 14, 2026 FDA drug enforcement ### [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 ...](https://isitonrecall.com/recall/fda-drug-event-99876-7a3176054b98cb67-nystatin-cream-usp-15-g-per-tube-rx-only-mfd-by-taro-pharmaceutical-industries-ltd-haifa-bay-israel/) Failed Stability Specifications Not Yet Classified Reported ongoing Distribution: U.S. Nationwide. [Official source for Nystatin Cream, USP, 15 g per tube, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa ...](https://api.fda.gov/drug/enforcement.json?search=event_id%3A%2299876%22) Aug 3, 2026 FDA drug enforcement ### [Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceuti...](https://isitonrecall.com/recall/fda-drug-d-0770-2026-carbamazepine-tablets-usp-200mg-1000-count-bottles-rx-only-manufactured-by-taro-pharmaceutical-indus/) CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing Class II Reported ongoing Distribution: US Nationwide. [Official source for Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured by: Taro Pharmaceuti...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0770-2026%22) Jun 17, 2026 FDA drug enforcement ### [Perampanel CIII Tablets, 6mg, Rx only, 30 Tablets, Mfd.by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbur...](https://isitonrecall.com/recall/fda-drug-d-0628-2026-perampanel-ciii-tablets-6mg-rx-only-30-tablets-mfd-by-taro-pharmaceutical-industries-ltd-haifa-bay-i/) Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets. Class II Reported ongoing Distribution: Nationwide in the USA [Official source for Perampanel CIII Tablets, 6mg, Rx only, 30 Tablets, Mfd.by: Taro Pharmaceutical Industries Ltd., H...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0628-2026%22) Jun 1, 2026 FDA drug enforcement ### [Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine, 150 Tablets per bottle, Distributed by: Ohm Laboratories, Inc., New Brunswick, NJ 08901. NDC 66336-561-30](https://isitonrecall.com/recall/fda-drug-d-0654-2026-fexofenadine-hydrochloride-tablets-usp-180-mg-antihistamine-150-tablets-per-bottle-distributed-by-oh/) Failed Impurities/Degradation Specifications Class III Reported ongoing Distribution: U.S. Nationwide [Official source for Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine, 150 Tablets per bottle, Distribute...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0654-2026%22) May 29, 2026 FDA drug enforcement ### [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 Indus...](https://isitonrecall.com/recall/fda-drug-d-0607-2026-budesonide-inhalation-suspension-1mg-2ml-30-x-2-ml-sterile-single-dose-ampules-5-single-dose-ampules/) 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 II Reported ongoing Distribution: Nationwide within the United States [Official source for Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules (5 Single-Dose A...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0607-2026%22) May 22, 2026 FDA drug enforcement ### [Xyvona (levorphanol tartrate tablets), 2mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by: Fort Bio-Phar...](https://isitonrecall.com/recall/fda-drug-d-0598-2026-xyvona-levorphanol-tartrate-tablets-2mg-100-tablets-rx-only-forte-biopharma-manufactured-by-ohm-labo/) 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 Class II Reported ongoing Distribution: Nationwide within the United States [Official source for Xyvona (levorphanol tartrate tablets), 2mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured b...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0598-2026%22) May 22, 2026 FDA drug enforcement ### [Xyvona (levorphanol tartrate tablets), 3mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by: Fort Bio-Phar...](https://isitonrecall.com/recall/fda-drug-d-0599-2026-xyvona-levorphanol-tartrate-tablets-3mg-100-tablets-rx-only-forte-biopharma-manufactured-by-ohm-labo/) 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 Class II Reported ongoing Distribution: Nationwide within the United States [Official source for Xyvona (levorphanol tartrate tablets), 3mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured b...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0599-2026%22) May 13, 2026 FDA company announcement ### [Aisling: DOXOrubicin Hydrochloride Liposome Injection 50mg/25 mL](https://isitonrecall.com/recall/fdapress-3187d30bdb6dd2df-aisling-doxorubicin-hydrochloride-liposome-injection-50mg-25-ml/) Presence of glass particles Not supplied Published notice; closure not supplied Distribution: Not supplied [Official source for Aisling: DOXOrubicin Hydrochloride Liposome Injection 50mg/25 mL](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sun-pharmaceutical-industries-inc-sun-pharma-initiates-voluntary-us-nationwide-recall-doxorubicin) May 12, 2026 FDA drug enforcement ### [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...](https://isitonrecall.com/recall/fda-drug-d-0580-2026-doxorubin-hydrochloride-liposome-injection-50-mg-25-ml-2mg-ml-25-ml-single-dose-vials-sterile-rx-onl/) Presence of Particulate matter: Particulate matter identified as glass. Class I Reported ongoing Distribution: U.S. Nationwide [Official source for DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL single-dose vials, Steril...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0580-2026%22) Mar 25, 2026 FDA drug enforcement ### [Fluocinonide, USP, 0.05% Cream, 15g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, ...](https://isitonrecall.com/recall/fda-drug-d-0475-2026-fluocinonide-usp-0-05-cream-15g-tube-rx-only-mfd-by-taro-pharmaceuticals-inc-brampton-ontario-canada/) Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing. Class II Reported ongoing Distribution: Nationwide in the USA. [Official source for Fluocinonide, USP, 0.05% Cream, 15g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, O...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0475-2026%22) Mar 25, 2026 FDA drug enforcement ### [Fluocinonide, USP, 0.05% Cream, 30g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, ...](https://isitonrecall.com/recall/fda-drug-d-0476-2026-fluocinonide-usp-0-05-cream-30g-tube-rx-only-mfd-by-taro-pharmaceuticals-inc-brampton-ontario-canada/) Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing. Class II Reported ongoing Distribution: Nationwide in the USA. [Official source for Fluocinonide, USP, 0.05% Cream, 30g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, O...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0476-2026%22) Mar 25, 2026 FDA drug enforcement ### [Fluocinonide, USP, 0.05% Cream, 60g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, ...](https://isitonrecall.com/recall/fda-drug-d-0477-2026-fluocinonide-usp-0-05-cream-60g-tube-rx-only-mfd-by-taro-pharmaceuticals-inc-brampton-ontario-canada/) Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing. Class II Reported ongoing Distribution: Nationwide in the USA. [Official source for Fluocinonide, USP, 0.05% Cream, 60g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, O...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0477-2026%22) Jan 27, 2026 FDA drug enforcement ### [Diclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by Taro Pharmaceuticals U.S.A., Inc., Hawth...](https://isitonrecall.com/recall/fda-drug-d-0342-2026-diclofenac-sodium-topical-gel-3-100-g-tube-rx-only-mfd-by-taro-pharmaceuticals-inc-brampton-ontario/) Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%. Class II Reported ongoing Distribution: US Nationwide. [Official source for Diclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Bram...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0342-2026%22) Dec 30, 2025 FDA drug enforcement ### [Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist. by: Taro Pharmaceuticals Inc., Hawthorn, NY 10532. NDC 51672-1365-4](https://isitonrecall.com/recall/fda-drug-d-0256-2026-fluocinolone-acetonide-solution-topical-solution-usp-0-01-60-ml-bottles-rx-only-dist-by-taro-pharmac/) Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D. Class III Reported ongoing Distribution: Nationwide within the USA [Official source for Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist. by: Ta...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0256-2026%22) Nov 26, 2025 FDA drug enforcement ### [Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applicator bottle, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel; Dist. by: Taro...](https://isitonrecall.com/recall/fda-drug-d-0257-2026-clindamycin-phosphate-usp-1-10-mg-ml-topical-solution-60-ml-per-applicator-bottle-rx-only-mfd-by-tar/) Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay. Class III Reported ongoing Distribution: Nationwide in the USA. [Official source for Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applicator bottle, Rx only,...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0257-2026%22) Oct 28, 2025 FDA drug enforcement ### [Lisdexamfetamine Dimesylate Capsules, 10 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Indus...](https://isitonrecall.com/recall/fda-drug-d-0144-2026-lisdexamfetamine-dimesylate-capsules-10-mg-cii-100-count-bottle-rx-only-manufactured-by-ohm-laborato/) Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules. Class II Reported ongoing Distribution: U.S Nationwide. [Official source for Lisdexamfetamine Dimesylate Capsules, 10 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0144-2026%22) Oct 28, 2025 FDA drug enforcement ### [Lisdexamfetamine Dimesylate Capsules, 20 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Indus...](https://isitonrecall.com/recall/fda-drug-d-0145-2026-lisdexamfetamine-dimesylate-capsules-20-mg-cii-100-count-bottle-rx-only-manufactured-by-ohm-laborato/) Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules. Class II Reported ongoing Distribution: U.S Nationwide. [Official source for Lisdexamfetamine Dimesylate Capsules, 20 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0145-2026%22) Oct 28, 2025 FDA drug enforcement ### [Lisdexamfetamine Dimesylate Capsules, 30 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Indus...](https://isitonrecall.com/recall/fda-drug-d-0146-2026-lisdexamfetamine-dimesylate-capsules-30-mg-cii-100-count-bottle-rx-only-manufactured-by-ohm-laborato/) Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules. Class II Reported ongoing Distribution: U.S Nationwide. [Official source for Lisdexamfetamine Dimesylate Capsules, 30 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0146-2026%22) Oct 28, 2025 FDA drug enforcement ### [Lisdexamfetamine Dimesylate Capsules, 40 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Indus...](https://isitonrecall.com/recall/fda-drug-d-0147-2026-lisdexamfetamine-dimesylate-capsules-40-mg-cii-100-count-bottle-rx-only-manufactured-by-ohm-laborato/) Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules. Class II Reported ongoing Distribution: U.S Nationwide. [Official source for Lisdexamfetamine Dimesylate Capsules, 40 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0147-2026%22) Oct 28, 2025 FDA drug enforcement ### [Lisdexamfetamine Dimesylate Capsules, 50 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Indus...](https://isitonrecall.com/recall/fda-drug-d-0148-2026-lisdexamfetamine-dimesylate-capsules-50-mg-cii-100-count-bottle-rx-only-manufactured-by-ohm-laborato/) Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules. Class II Reported ongoing Distribution: U.S Nationwide. [Official source for Lisdexamfetamine Dimesylate Capsules, 50 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0148-2026%22) ## Reasons in these listed records - Failed Stability Specifications - CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing - Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets. - Failed Impurities/Degradation Specifications These examples come from this result page and are not a ranking of every recall reason. ## Checking SUN PHARMACEUTICAL INDUSTRIES INC ### Is there a recall on sun pharmaceutical industries inc right now? This archive contains 87 records, including 33 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search SUN PHARMACEUTICAL INDUSTRIES INC](https://isitonrecall.com/check/?q=SUN%20PHARMACEUTICAL%20INDUSTRIES%20INC) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)