Sun Pharmaceutical Industries, Inc.

Complete recall history across all FDA and CPSC categories — 40 total recalls

Sun Pharmaceutical Industries, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (40)

FDA drug safety enforcement actions by Sun Pharmaceutical Industries, Inc.

Date Product Reason Class
Mar 13, 2020 Doxycycline Capsules, USP, 100 mg, 50-count bottle, Rx only, Manufactured by:... CGMP Deviations: Doxycycline capsules were not manufactured under Current Goo... Class II
Mar 13, 2020 Doxycycline Capsules, USP, 75 mg, 100-count bottle, Rx only, Manufactured by:... CGMP Deviations: Doxycycline capsules were not manufactured under Current Goo... Class II
Mar 9, 2020 Atorvastatin Calcium Tablets, USP 40 mg, Rx only, 500-count bottle, Manufactu... Presence of foreign substance: Foreign matter has been identified as latex gl... Class II
Jan 14, 2020 Testosterone Cypionate for Injection, 2,000 mg/10 mL (200 mg/mL), a) 1 mL Sin... cGMP Deviations; released lots were manufactured under similar manufacturing ... Class II
Jan 14, 2020 Testosterone Cypionate for Injection, USP, 1,000 mg/10 mL (100 mg/mL), 10 mL ... cGMP Deviations; released lots were manufactured under similar manufacturing ... Class II
Dec 26, 2019 Sumatriptan Succinate Tablets, 50 mg, packaged in a) 9 (1x9) Unit-of use blis... Failed Impurities/Degradation Specifications; out-of-specification results ob... Class II
Dec 26, 2019 Sumatriptan Succinate Tablets, 100 mg packaged in 9 (1X9) Unit-of-use bliste... Failed Impurities/Degradation Specifications; out-of-specification results ob... Class II
Jun 5, 2019 Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg/ Extended-Relea... Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation... Class II
Jun 5, 2019 Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended-Releas... Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation... Class II
Jun 5, 2019 Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extende... Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation... Class II
Jun 5, 2019 Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Exten... Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation... Class II
Jan 24, 2019 BromSite (bromfenac ophthalmic solution) 0.075%, 5 mL bottles, Rx Only, Distr... Bromfenac Ophthalmic Solution, 0.075% (Sterile 5 mL) may have a lack of steri... Class II
Jan 3, 2019 Vecuronium Bromide for Injection 20 mg* *1mg/mL when reconstituted to 20 mL L... Presence of Particulate Matter: Foreign matter identified as glass detected ... Class I
Jan 3, 2019 Vecuronium Bromide for Injection 10 mg*, *1mg/mL when reconstituted to 10 mL ... Presence of Particulate Matter: Foreign matter identified as glass detected ... Class I
Dec 26, 2018 LOPERAMIDE HCL TABLETS USP, 2 mg, ANTI-DIARRHEAL, 24 caplets per carton, OTC... Labeling Not Elsewhere Classified: The front panel indicates 24 caplets wher... Class III
Dec 7, 2018 Absorica (Isotretinoin) Capsules 30 mg USP, 30 capsules (3x10 Prescription Pa... Subpotent Drug: Isotretinoin content results were lower than the specificatio... Class III
Jul 12, 2018 Testosterone Cypionate Injection, USP, 200 mg/mL, Rx only, 10 mL vials, Distr... Presence of Particulate Matter: organic and inorganic compounds detected in v... Class II
Jul 3, 2018 Metformin Hydrochloride Extended Release Tablets, USP, 500 mg, packaged in a ... Presence of foreign substance: One lot fo Metformin Hydrochloride Extended Re... Class II
Apr 26, 2018 Riomet (metformin hydrochloride oral solution), 500 mg/5 mL (16 fl. oz.), 473... Labeling: Not Elsewhere Classified: Sun Pharma has decided to initiate this r... Class III
Apr 19, 2018 Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg, Rx Only, 500-co... Presence of Foreign Substance:Sun Pharma is recalling one (1) lot of Sulfamet... Class II
Feb 5, 2018 Azelastine HCl Nasal Solution (Nasal Spray) 0.1% (137 mcg per spray), 30 mL, ... Sun Pharmaceutical is recalling Azelastine HCl Nasal Solution, 0.1% (30 mL Bo... Class III
Jan 16, 2018 DOXOrubicin Hydrochloride Liposome Injection, 20 mg/10 ml (2 mg/mL), 10 mL Si... Lack Of Assurance Of Sterility Class II
Apr 18, 2017 Children's Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30-count bottle, ... Failed Tablet/Capsule Specifications: out of specification results for increa... Class III
Apr 18, 2017 Riomet (metformin hydrochloride) Oral Solution Cherry Flavored 500 mg /5 mL, ... Microbial Contamination of Non-Sterile Products Class II
Mar 22, 2017 Olanzapine Tablets, 20 mg, packaged in a) 30-count bottles (NDC 62756-556-83)... Failed Impurities/Degradation Specifications: out of specification results fo... Class III
Mar 22, 2017 Olanzapine Tablets, 10 mg, packaged in a) 30-count bottles (NDC 62756-554-83)... Failed Impurities/Degradation Specifications: out of specification results fo... Class III
Mar 22, 2017 Olanzapine Tablets, 2.5 mg, 1000-count bottles, Rx Only, Distributed by: Sun ... Failed Impurities/Degradation Specifications: out of specification results fo... Class III
Mar 22, 2017 Olanzapine Tablets, 7.5 mg, packaged in a) 30-count bottles (NDC 62756-553-83... Failed Impurities/Degradation Specifications: out of specification results fo... Class III
Mar 15, 2017 Testosterone Cypionate Injection , USP, 200 mg/mL, 1 mL vial , For Intramusc... Presence of Particulate Matter Class II
Jan 12, 2017 Sun Pharma Carbidopa and Levodopa Tablets USP 25 mg/250 mg a) 100-count bottl... Failed Dissolution Specifications Class II
Jan 5, 2017 Alfuzosin Hydrochloride Extended-release Tablets, 10 mg, 100-count bottles, R... Presence of Foreign Substance: consumer complaint for foreign matter embedded... Class II
Dec 20, 2016 buPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, 60 count ... Failed Dissolution Specifications; 18 month stability time point Class III
Dec 20, 2016 buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, a) 60 (ND... Failed Dissolution Specifications; 18 month stability time point Class III
Oct 28, 2016 KENALOG (Triamcinolone Acetonide) Spray with Spray Tube Topical Aerosol, USP,... Failed Stability Specifications: Low Out of Specification results for alcohol... Class III
Sep 13, 2016 buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, Twice-A-D... Failed Dissolution Specifications Class III
Jun 27, 2016 Carvediol Tablets, USP, 25 mg, 100-count bottle (NDC 57664-247-88), 500-count... Failed Impurities/Degradation Specifications Class III
Jun 27, 2016 Carvediol Tablets, USP, 12.5 mg, 500-count bottle (NDC 57664-245-13), 1000-c... Failed Impurities/Degradation Specifications Class III
Jun 27, 2016 buPROPion Hydrochloride Extended Release Tablets USP (SR) 150 mg Rx Only 60 t... Failed Dissolution Specifications Class III
Jun 27, 2016 Carvediol Tablets, USP, 6.25 mg, 100-count bottle (NDC 57664-244-18), 500-cou... Failed Impurities/Degradation Specifications Class III
Jun 27, 2016 Carvediol Tablets , USP, 3.125 mg, 100-count bottle (NDC 57664-242-88). 500-c... Failed Impurities/Degradation Specifications Class III

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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