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.
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