Records and reported status
Jan 18, 2024 FDA drug enforcement
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II Reported completed
Distribution: Nationwide in the USA
Official source for Mesalamine Delayed-Release Tablets, USP 1.2 g per tablet, Rx Only, 120 Tablets per bottle, Once D... Jan 18, 2024 FDA drug enforcement
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II Reported completed
Distribution: Nationwide in the USA
Official source for Niacin Extended-Release Tablets, USP 1000mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun ... Jan 18, 2024 FDA drug enforcement
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II Reported completed
Distribution: Nationwide in the USA
Official source for Niacin Extended-Release Tablets, USP 500mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun P... Jan 18, 2024 FDA drug enforcement
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II Reported completed
Distribution: Nationwide in the USA
Official source for Zolpidem Tartrate Extended-Release Tablets, USP 6.25 mg, Rx Only, 100 Tablets per bottle, Distrib... Jan 18, 2024 FDA drug enforcement
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II Reported completed
Distribution: Nationwide in the USA
Official source for Zolpidem Tartrate Extended-Release Tablets, USP 12.5mg, Rx Only, 100 Tablets per bottle, Distribu... Jan 18, 2024 FDA drug enforcement
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II Reported completed
Distribution: Nationwide in the USA
Official source for Fexofenadine Hydrochloride Tablets, USP 180mg, Antihistamine, Allergy, 24 hour, a) 30 Tablets per... Dec 4, 2023 FDA drug enforcement
Failed Impurities/Degradation Specifications
Class II Reported terminated
Distribution: Nationwide
Official source for Liothyronine Sodium Tablets, USP 5 mcg, 100-count bottle, Rx Only, Distributed by: Sun Pharmaceut... Nov 22, 2023 FDA drug enforcement
Failed Dissolution Specifications
Class III Reported terminated
Distribution: Nationwide
Official source for buPROPion Hydrochloride Extended-Release Tablets, USP (SR) 200 mg, 60 Tablets bottle, Distributed... Oct 20, 2023 FDA drug enforcement
Failed Impurities/Degradation Specifications.
Class II Reported terminated
Distribution: Nationwide within the United States
Official source for Liothyronine Sodium Tablets, USP, 5 mcg, 100-count bottles, Rx only, Distributed by: Sun Pharmace... Oct 20, 2023 FDA drug enforcement
Failed Impurities/Degradation Specifications.
Class II Reported terminated
Distribution: Nationwide within the United States
Official source for Liothyronine Sodium Tablets, USP, 25 mcg, 100-count bottles, Rx only, Distributed by: Sun Pharmac... Oct 4, 2023 FDA drug enforcement
Failed Dissolution Specifications
Class III Reported terminated
Distribution: Nationwide in the USA.
Official source for Bupropion Hydrochloride Extended-Release Tablets USP (SR), 150 mg, 60 tablets bottle, Rx Only, Di... Sep 7, 2023 FDA drug enforcement
Subpotent: Out of Specification result observed for low assay
Class III Reported terminated
Distribution: Nationwide wide in the USA
Official source for Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vi... Jul 18, 2023 FDA drug enforcement
Out of Specification result observed in content uniformity testing
Class III Reported terminated
Distribution: Nationwide in the USA
Official source for Dofetilide Capsules 500 mcg (0.5mg), 60-count bottle, Rx Only, Manufactured by Sun Pharmaceutical... Jul 13, 2023 FDA drug enforcement
Presence of Foreign Substance: Metal embedded in a tablet.
Class II Reported terminated
Distribution: Nationwide
Official source for Methylphenidate Hydrochloride Tablets, USP 20mg, Rx Only, 100 Tablets per bottle, Manufactured by... Jul 10, 2023 FDA drug enforcement
Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing
Class II Reported terminated
Distribution: Distributed nationwide in the USA.
Official source for Tiagabine Hydrochloride Tablets, 2 mg, 30-count bottle, Distributed by Sun Pharmaceutical Industr... Jul 5, 2023 FDA drug enforcement
Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.
Class III Reported terminated
Distribution: USA nationwide.
Official source for Loteprednol Etabonate Ophthalmic Suspension, 5 mg/mL (0.5%), packaged as one bottle in a carton i... May 30, 2023 FDA drug enforcement
Subpotent drug
Class II Reported terminated
Distribution: USA nationwide
Official source for Amphotericin B Liposome for Injection, 50mg/vial, Rx only, Distributed by Sun Pharmaceutical Indu... May 9, 2023 FDA drug enforcement
Failed Dissolution Specifications; during stability testing
Class II Reported terminated
Distribution: Nationwide in the U.S.A
Official source for buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablets, Rx Only, Distribu... May 3, 2023 FDA drug enforcement
CGMP Deviations
Class II Reported terminated
Distribution: Product was distributed to 19 distributors nationwide.
Official source for Buprenorphine Sublingual Tablets, 8 mg, 30 count-bottles, Rx only, Manufactured by: Sun Pharma, N... Mar 29, 2023 FDA drug enforcement
Failed Impurities/Degradation Specifications: Above the specification limits yielded for related substance norepinephrine sulfonic acid impurity during routine product monitoring.
Class III Reported terminated
Distribution: Nationwide in the USA
Official source for Norepinephrine Bitartrate Injection, USP, 4 mg/4 mL* (1 mg/mL), 4 mL Single-dose Fliptop Vial (ND...
Reasons in these listed records CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. Failed Impurities/Degradation Specifications Failed Dissolution Specifications 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 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 and the agency's current notices.
Where can I find older records? Use monthly 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.