Manufacturer record

Unicure India Ltd: regulatory record

Last checked 3 November 2026. Source: CDSCO monthly NSQ alerts and state drug-testing laboratories

97 batches manufactured by Unicure India Ltd (Uttarakhand) were declared Not of Standard Quality between April 2019 and September 2026. Records are batch-specific findings by government laboratories as published in CDSCO's monthly alerts; where a company has stated that a flagged batch was counterfeit, that statement is noted when reported.

Most recent flagged batch: EOCT1313, Olanzapine Tablets IP 5 mg (exp Jun 2027). DTL, Thrissur (state lab) found it not of standard quality: The sample does not conform to IP standards with respect to the test Assay. Listed in the September 2026 alert.

Records by type

97 records linked to Unicure India Ltd in the datasets we hold. A zero means nothing is on record in those datasets, not that nothing ever happened. What the labels mean.

0Banned or prohibited
0Recalled or suspended
97Failed a lab test
0Regulatory notice
Primary government sourceTier 1: government primary source

CDSCO drug alerts: Not of Standard Quality and spurious drugs

CDSCO · CDSCO monthly NSQ alerts, Apr 2019 to Sep 2026

View original document

Scope. A company appearing here is not a finding that its products are unsafe. Regulatory actions can apply to one batch, one formulation, one period or one state. Always check the linked government document for the current position, and tell us if something is out of date. How we label records.

97
NSQ batches since 2019
52
Products affected
Assay
Most common failure
Sep 2026
Latest alert

Flagged batches per year

2019 · 42020 · 52021 · 82022 · 72023 · 82024 · 182025 · 92026 · 38

All flagged batches

Product Batch Reason declared NSQ Tested by Alert
Olanzapine Tablets IP 5 mg Batch EOCT1313Mfg Jul 2025 · Exp Jun 2027 The sample does not conform to IP standards with respect to the test Assay.Assay DTL, ThrissurState lab Sep 2026
Folic Acid Tablets IP 0.4 mg Batch FO1TE011Mfg Oct 2024 · Exp Sep 2027 The sample does not conform to IP standards. It fails the Descriptive part for tablets as per IP, as specified in the Laboratory Protocol.Other DTL, TVPMState lab Sep 2026
Folic Acid Tablets IP 0.4 mg Batch FO1TE058Mfg Nov 2024 · Exp Oct 2027 The sample does not conform to IP standards. It fails the Descriptive part for tablets as per IP.Other DTL, TVPMState lab Sep 2026
Folic Acid Tablets IP 0.4 mg Batch FO1TE045Mfg Oct 2024 · Exp Sep 2027 The sample does not conform to the IP standards with respect to Description.Description DTL, ThrissurState lab Sep 2026
Folic Acid Tablets IP 0.4 mg Batch FO1TE064Mfg Nov 2024 · Exp Oct 2027 The sample does not conform to IP standards. It fails the 'Descriptive part' for tablets as per IP.Other DTL, TVPMState lab Sep 2026
Folic Acid Tablets IP 0.4 mg Batch FO1TE009Mfg Oct 2024 · Exp Sep 2027 The sample does not conform to IP standards. It fails the 'Descriptive part' for tablets as per IP, as specified in the Laboratory Protocol.Other DTL TVPMState lab Sep 2026
Folic Acid Tablets IP 0.4 mg Batch FO1TE010Mfg Oct 2024 · Exp Sep 2027 The sample does not conform to IP standards. It fails the 'Descriptive part' for tablets as per IP, as specified in the Laboratory Protocol.Other DTL, TVPMState lab Sep 2026
Folic Acid Tablets IP 0.4 mg Batch FO1TE050Mfg Oct 2024 · Exp Sep 2027 The sample does not conform to IP standards. It fails the 'Descriptive part' for tablets as per IP, as specified in the Laboratory Protocol.Other DTL, TVPMState lab Sep 2026
Folic Acid Tablets IP 0.4 mg Batch FO1TE022Mfg Oct 2024 · Exp Sep 2027 Sample does not conform to IP standards. This particular batch of sample fails in Descriptive part.Other RDTL , ErnakulamState lab Sep 2026
Folic Acid Tablets IP 0.4 mg Batch FO1TE067Mfg Nov 2024 · Exp Oct 2027 The sample does not conform to IP standards. It fails the 'Descriptive part' for tablets as per IP.Other DTL, TVPMState lab Sep 2026
Folic Acid Tablets IP 0.4 mg Batch FO1TE026Mfg Oct 2024 · Exp Sep 2027 The sample does not conform to IP standards. It fails the 'Descriptive part' for tablets as per IP.Other DTL, TVPMState lab Sep 2026
Folic Acid Tablets IP 0.4 mg Batch FO1TE016Mfg Oct 2024 · Exp Sep 2027 The sample does not conform to IP standards. It fails the 'Descriptive part' for tablets as per IP, as specified in the Laboratory Protocol.Other DTL, TVPMState lab Sep 2026
Folic Acid Tablets IP 0.4 mg Batch FO1TE065Mfg Nov 2024 · Exp Oct 2027 The sample does not conform to IP standards. If fails the tests'Assay' and 'Dissolution' as per IP, as specified in the Laboratory ProtocolAssay DTL,TVPMState lab Sep 2026
Folic Acid Tablets IP 0.4 mg Batch FO1TE023Mfg Oct 2024 · Exp Sep 2027 The sample does not conform to the IP Standards with respect to DescriptionDescription DTL, ThrissurState lab Sep 2026
Folic Acid Tablets IP 0.4 mg Batch FO1TE035Mfg Oct 2024 · Exp Sep 2027 The sample does not conform to the IP Standards with respect to DescriptionDescription DTL, ThrissurState lab Sep 2026
Vildagliptin Tablets I.P. 50 mg Batch VFGT1214Mfg Mar 2025 · Exp Feb 2027 The sample does not conform to I.P with respect to the test for Assay of VildagliptinAssay CDTL, IndoreCDSCO lab Aug 2026
Ibuprofen Tablets I.P 400mg Batch IBBT1401Mfg Apr 2026 · Exp Mar 2028 Dissolution Test: (Four out of Six units at stage I are less than Q-25% i.e less than 50%)Dissolution SDTL, PunjabState lab Aug 2026
Folic Acid Tablets IP 0.4 mg Batch F01TE055Mfg Oct 2024 · Exp Sep 2027 The particular batch of sample fails in Descriptive part and tests Dissolution and Assay of Folic acidAssay RDTL, EKMState lab Aug 2026
Azithromycin Oral Suspension IP 100mg/5ml Batch AZS1401Mfg May 2026 · Exp Apr 2028 The content of Azithromycin I.P. eq to Anhydrous Azithromycin found to be 80.34 mg per 5 ml (80.34%) against label claim of 100 mg per 5 mlLabelling SDTL, PunjabState lab Aug 2026
Voglibose Tablets I.P 0.3mg Batch VBT1408Mfg Apr 2026 · Exp Mar 2028 MisbrandedMisbranded Andmand NicobarState lab Jun 2026
Terbutaline Sulphate, Bromhexine Hydrochloride, Guaiphenesin & Menthol Syrup Batch EM1LF005Mfg Apr 2025 · Exp Mar 2027 ContentOther DTL, Chennai-06State lab Jun 2026
Folic Acid Tablets IP 0.4 mg Batch FO1TE063Mfg Nov 2024 · Exp Oct 2027 Sample does not conform to IP standards. It fails the tests Dissolution and Assay as per IP.Assay DTL, KonniState lab Jun 2026
Folic Acid Tablets IP. 0.4 mg Batch FO1TE033Mfg Oct 2024 · Exp Sep 2027 DescriptiveOther RDTL ErnakulamState lab May 2026
Folic Acid Tablets IP. 0.4 mg Batch FO1TE048Mfg Oct 2024 · Exp Sep 2027 Description, Dissolution and AssayAssay DTL ThrissurState lab May 2026
Atorvastatin Tablets IP 10mg Batch AUVT1304Mfg Jul 2025 · Exp Jun 2027 Does not conform to IP Standards with respect to the Dissolution TestDissolution Government Analyst, Food & Drugs Admn. Bambolim, GoaState lab May 2026
Aspirin Gastro-resistant Tablets IP 75 mg Batch ANET1273Mfg Oct 2024 · Exp Sep 2026 Dissolution, Salicylic Acid and Assay as per IPAssay DTL KonniState lab May 2026
Aspirin Gastro-resistant Tablets IP 75 mg Batch ANET1283Mfg Oct 2024 · Exp Sep 2026 Dissolution, Salicylic Acid and AssayAssay DTL ThrissurState lab May 2026
Aspirin Gastro-Resistant Tablets IP 75mg Batch ANET1243Mfg May 2024 · Exp Apr 2026 The Sample fails the test 'Descriptive Part, Dissolution, Salicylic Acid and Assay as per IPAssay DTL ThiruvananthapuramState lab Apr 2026
Lactulose Solution IP 10 gm/15ml Batch LLS1337Mfg Aug 2025 · Exp Jul 2027 The sample does not conform to IP with respect to test for Microbial contamination and Assay/content of LactuloseAssay CDL, KolkataCDSCO lab Mar 2026
Lactulose Solution IP 10 gm/15ml Batch LLS1311Mfg May 2025 · Exp Apr 2027 The sample does not conform to IP with respect to test for Microbial contamination and Assay/content of LactuloseAssay CDL, KolkataCDSCO lab Mar 2026
Paracetamol Tablets IP 500mg Batch PCT1211Mfg Aug 2024 · Exp Jul 2026 The sample does not confirm to IP2022 requirement withespect to Dissolution TestDissolution DTL, Dalgate Srinagar Kashmir (J & K)State lab Feb 2026
Labetalol Tablets I.P 100mg Batch LA1TE011Mfg Aug 2024 · Exp Jul 2026 The sample does not conform to IP Standards with respect to the test Dissolution.Dissolution DTL ThrissurState lab Feb 2026
Fenofibrate Capsules I.P (200 mg) Batch FFC1201Mfg Jul 2024 · Exp Jun 2026 Test for Uniformity of Weight and DissolutionDissolution DTL, Bengaluru, KarnatakaState lab Feb 2026
Aspirin Gastro-resistant Tablets IP 75 mg. Batch ANET1295Mfg Dec 2024 · Exp Nov 2026 The sample does not conform to I.P.w.r.t. the tests for Dissolution in Acid Stage for Aspirin.Dissolution RDTL, GuwahatiState lab Feb 2026
Aspirin Gastro Resistant Tablets IP 75mg Batch ANET 1269Mfg Oct 2024 · Exp Sep 2026 Sample fails the test Dissolution' as per IP as specified in the Laboratory ProtocolDissolution DTL ThiruvananthapuramState lab Feb 2026
Terbutaline Sulphate, Bromhexine Hydrochloride, Guiaphenesin & Menthol Syrup Batch EM1LF002Mfg Apr 2025 · Exp Mar 2027 ContentOther Drugs Testing Laboratory, Madurai-19State lab Jan 2026
Iron And Folic Acid Tablets I.P. Batch IFAT1245Mfg Mar 2025 · Exp Feb 2027 The sample does not conform to IP with respect to Description.Description CDL, KolkataCDSCO lab Jan 2026
Ciprofloxacin Tablets I.P 500mg Batch CCT1303Mfg Apr 2025 · Exp Mar 2027 Test for Uniformity of WeightUniformity of weight/content RDTL, Hubli, KarnatakaState lab Jan 2026
Hydroxyzine Oral Solution I.P. Batch HO1LF002Mfg Jun 2025 · Exp May 2027 The sample does not conform to claim as per IP 2022 in respect to The test of Related SubstanceRelated substances CDL, KolkataCDSCO lab Dec 2025
Glipizide and Metformin Tablets USP Batch URDT0328Mfg Jan 2023 · Exp Dec 2025 The sample does not conform to the IP with respect to Dissolution of Glipizide.Dissolution DTL UdaipurState lab Dec 2025
Amitriptyline Tablets IP 25 mg Batch AMT1305Mfg May 2025 · Exp Apr 2027 UniformityUniformity of weight/content Drugs Testing Laboratory, Madurai-19State lab Nov 2025
Cloberasol Propionate and Salicylic Acid Ointment Batch 1210CSOMfg Mar 2025 · Exp Feb 2027 ContentOther Drugs Testing Laboratory, Chennai-06State lab Oct 2025
Aspirin Gastro- resistant Tablets IP (150mg) Batch URDT2771Mfg Nov 2023 · Exp Oct 2025 Assay of AspirinAssay KarnatakaState lab Aug 2025
Paracetamol Tablets IP (500mg) Jan Aushadhi Batch PCT1208Mfg Aug 2024 · Exp Jul 2026 Dissolution test of paracetamol.Dissolution DTL Srinagar (J&K) & MDTL Kathua (J&K)State lab Jun 2025
Nitrofurantoin Tablets I.P 100 mg Batch NFDT1201Mfg Oct 2024 · Exp Sep 2026 DissolutionDissolution CDTL IndoreCDSCO lab Jun 2025
Labetalol Tablets IP 100mg Batch LA1TE012Mfg Aug 2024 · Exp Jul 2026 Dissolution of Labetalol Hydrochloride TabletsDissolution CDTL ChennaiCDSCO lab Jun 2025
Aspirin Gastro Resistant Tab IP 75 mg Batch ANET1235Mfg May 2024 · Exp Apr 2026 It fails the test ?Dissolution? Specified in the laboratory protocol as per IPDissolution DTL ThiruvananthapuramState lab Apr 2025
Metoprolol Succinate Prolonged Release Tablets IP Batch URDT0654Mfg Mar 2023 · Exp Feb 2025 It fails the test ?Assay? as per IP standards [Amendment List - 05 to IP 2022]Assay DTL ThiruvananthapuramState lab Dec 2024
Metoprolol Succinate Prolonged Release Tablets IP Batch URDT0653Mfg Mar 2023 · Exp Feb 2025 It fails the test ?Assay? as per IP standards [Amendment List - 05 to IP 2022]Assay DTL ThiruvananthapuramState lab Dec 2024
Metoprolol Succinate Prolonged Release Tablets IP Batch URDT0652Mfg Mar 2023 · Exp Feb 2025 It fails the test ?Assay? as per IP standards [Amendment List - 05 to IP 2022]Assay DTL ThiruvananthapuramState lab Dec 2024
Aspirin Gastro- resistant Tablets IP 75mg Batch ANET1121Mfg Aug 2023 · Exp Jul 2025 Test of Dissolution Buffer StageDissolution CDL KolkataCDSCO lab Dec 2024
Terbutaline Sulphate, Ambroxol Hydrochloride and Guaiphenesin syrup Batch TM1LE027Mfg Apr 2024 · Exp Mar 2026 The sample fails descriptive part for liquid oral dosage forms as per schedule V of Drugs & Cosmetics Act and Rules. The syrup contains red coloured sedimented particlesDescription DTL ThiruvananthapuramState lab Nov 2024
Paracetamol Tablets I.P. 500mg Batch PCT1212Mfg Aug 2024 · Exp Jul 2026 DissolutionDissolution SDTL Agartala, TripuraState lab Nov 2024
Aspirin Gastro- resistant Tablets IP 75 mg Batch ANET1107Mfg Jul 2023 · Exp Dec 2024 Test for Salicylic AcidOther CDL KolkataCDSCO lab Nov 2024
Aspirin Gastro Resistant Tab IP Batch URDT2785Mfg Nov 2023 · Exp Oct 2025 It fails the test ?Dissolution? Specified in the Laboratory Protocol as per IPDissolution DTL ThiruvananthapuramState lab Nov 2024
Paracetamol Tablets IP 650 mg [Nopain-650] Batch URDT2433Mfg Oct 2023 · Exp Sep 2026 It fails the test ?Dissolution? Specified in the Laboratory Protocol as per IPDissolution DTL ThiruvananthapuramState lab Oct 2024
Calcium and Vitamin D3 Tablets I.P. Batch UDT11151Mfg Aug 2023 · Exp Jan 2025 Assay of vitamin D3Assay RDTL GuwahatiCDSCO lab Aug 2024
Sodium Valporate Gastro Resistant Tablets IP 200 mg Batch SVT1140Mfg Sep 2023 · Exp Aug 2026 It fails the test ?Dissolution? as per IPDissolution DTL ThiruvananthapuramState lab Jul 2024
Etamsylat Tablets 500 mg Batch ELT1104Mfg Feb 2024 · Exp Jul 2024 DescriptionDescription CDTL MumbaiCDSCO lab Jun 2024
Sodium Valproate Gastro-resistant Tablets IP 200 mg Batch SVT1136Mfg Jul 2023 · Exp Dec 2024 Dissolution in ACID stageDissolution CDTL MumbaiCDSCO lab Mar 2024
Diacerein Tablets 50 mg Batch DCT1102Mfg Oct 2023 · Exp Sep 2025 DescriptionDescription CDTL MumbaiCDSCO lab Mar 2024
Calcium and Vitamin D3 Tablets I.P. Batch UDT10723Mfg Mar 2023 · Exp Aug 2024 DescriptionDescription RDTL GuwahatiState lab Mar 2024
Oseltamivir Oral Suspension I.P. 12 mg Batch URDP1153Mfg May 2023 · Exp Oct 2024 DescriptionDescription CDL KolkataCDSCO lab Feb 2024
Ondansetron Tablets IP 4 mg Batch SMT1006Mfg Nov 2022 · Exp Oct 2024 DissolutionDissolution RDTL GuwahatiState lab Jan 2024
Calcium and Vitamin D3 Tablets I.P Batch UDT10704Mfg Mar 2023 · Exp Aug 2024 DescriptionDescription RDTL GuwahatiState lab Jan 2024
Piroxicam Tablets I.P. 20 mg, Batch URDT2340Mfg Oct 2023 · Exp Sep 2026 DissolutionDissolution CDL KolkataCDSCO lab Dec 2023
CALCIUM AND VITAMIN D3 TABLETS I.P. Batch UDT10673Mfg Feb 2023 · Exp Jul 2024 DescriptionDescription RDTL GuwahatiState lab Dec 2023
Montelukast Sodium and Levocetirizine Hydrochloride Tablets I.P. Batch MLCT1026Mfg Feb 2023 · Exp Jan 2025 DissolutionDissolution CDL KolkataCDSCO lab Nov 2023
Ramipril Tablets I.P. 5 mg. Batch RMFT1001Mfg Jun 2022 · Exp May 2024 content of Ramipril (Assay)Assay RDTL GuwahatiState lab Oct 2023
Lorazepam Tablets I.P. 2 mg Batch LZMT100 6Mfg Feb 2023 · Exp Jan 2025 Dissolution and AssayAssay CDTL MumbaiCDSCO lab Aug 2023
Prednisolone Tablets I.P. 5 mg Batch PDT1009Mfg Oct 2022 · Exp Sep 2024 Related SubstancesRelated substances CDL KolkataCDSCO lab Jun 2023
CLOZAPINE TABLETS I.P. 100 MG Batch CZPT1006Mfg Nov 2022 · Exp Apr 2024 AssayAssay CDTL HyderabadCDSCO lab Jun 2023
Zinc Sulphate Dispersible Tablets IP 20 mg Batch ZST922Mfg Feb 2022 · Exp Jan 2024 AssayAssay CDTL ChennaiCDSCO lab Feb 2023
Zinc Sulphate Dispersible Tablets IP 20 mg Batch ZST903Mfg Jan 2022 · Exp Dec 2023 AssayAssay CDTL ChennaiCDSCO lab Dec 2022
Zinc Sulphate Dispersible Tablets IP 20 mg Batch ZST922Mfg Feb 2022 · Exp Jan 2024 AssayAssay CDTL ChennaiCDSCO lab Nov 2022
Ramipril Tablets IP 5.0 mg Batch RMFT905Mfg Oct 2021 · Exp Sep 2023 Assay of RamiprilAssay RDTL ChandigarhCDSCO lab Nov 2022
PRE AND PROBIOTIC CAPSULES Batch SL1CB016Mfg Nov 2021 · Exp Apr 2023 Identification and Assay of Streptococcus faecalisAssay RDTL ChandigarhCDSCO lab Jun 2022
Methylcobalamin Tablets 500 mcg Batch MBT 904Mfg May 2021 · Exp Apr 2023 AssayAssay CDL KolkataCDSCO lab Mar 2022
Finasteride Tablets I.P. 5 mg Batch FNST901Mfg Jun 2021 · Exp May 2023 DissolutionDissolution CDL KolkataCDSCO lab Mar 2022
Aspirin Gastro- resistant Tablets I.P. 150 mg Batch APET901Mfg May 2021 · Exp Apr 2023 Salicylic AcidOther CDTL MumbaiCDSCO lab Mar 2022
Vitamin B ? Complex Tablets NFI III Batch VPT801Mfg Jun 2020 · Exp Nov 2021 Description, Assay of Vitamin B1 & Calcium PantothenateAssay CDL KolkataCDSCO lab Nov 2021
NORFLOXACIN TABLETS IP 400 MG Batch NT802Mfg Oct 2020 · Exp Sep 2022 DissolutionDissolution RDTL ChandigarhCDSCO lab Oct 2021
Atorvastatin Tablets I.P. 20 mg. Batch AVBT806Mfg Oct 2020 · Exp Sep 2022 DissolutionDissolution RDTL GuwahatiCDSCO lab Aug 2021
Sodium Valproate Gastro Resistant Tablets IP 200 mg Batch SVT871Mfg Dec 2020 · Exp May 2022 Related SubstancesRelated substances CDL KolkataCDSCO lab Jul 2021
Atorvastatin Tablets IP 20 mg Batch AVBT802Mfg Jul 2020 · Exp Jun 2022 DissolutionDissolution RDTL GuwahatiCDSCO lab Jun 2021
Alusil (Aluminium, Magnesium and Simethicone Chewable Tablets I.P.) Batch ACT801Mfg Aug 2020 · Exp Jul 2022 Assay of Polydimethyl-siloxane (Simethicone)Assay CDL KolkataCDSCO lab Jun 2021
Nofloxacin Tablets I.P. 400 mg Batch NT801Mfg Jul 2020 · Exp Jun 2022 DissolutionDissolution RDTL GuwahatiCDSCO lab May 2021
Aspirin Gastro-Resistant Tablets IP 150 mg Batch APET716Mfg Jun 2019 · Exp May 2021 Test for Salicylic AcidOther CDTL MumbaiCDSCO lab Feb 2021
SULFASALAZINE TABLETS B.P. 500 mg Batch SSZT718Mfg Mar 2020 · Exp Feb 2022 Related SubstancesRelated substances RDTL ChandigarhCDSCO lab Dec 2020
Ondansetron Tablets I.P. 8 mg Batch SMAT 703Mfg Nov 2019 · Exp Oct 2021 DescriptionDescription CDL KolkataCDSCO lab Oct 2020
Telmisartan Tablets I.P. 20 mg Batch TLMT703Mfg Jul 2019 · Exp Jun 2021 DissolutionDissolution CDL KolkataCDSCO lab Jun 2020
Setnorm ? 4 (Ondansetron Tablets IP 4 mg) Batch SMT610ZMfg Feb 2019 · Exp Jan 2021 DescriptionDescription CDL KolkataCDSCO lab Jun 2020
Tranexamic Acid Tablets I.P. 500mg Batch TAT607Mfg Oct 2018 · Exp Sep 2020 DisintegrationDisintegration RDTL GuwahatiCDSCO lab Apr 2020
Thyrocure-50 (Thyroxine Tablets I.P. 50 mcg) Batch THAT616Mfg Dec 2018 · Exp May 2020 AssayAssay CDL KolkataCDSCO lab Sep 2019
Thyrocure-100 (Thyroxine Tablets I.P. 100 mcg) Batch THDT611Mfg Dec 2018 · Exp May 2020 AssayAssay CDL KolkataCDSCO lab Aug 2019
Thyrocure - 100 (Thyroxine Tablets I.P. 100 mcg) Batch THDT605Mfg Jul 2018 · Exp Dec 2019 AssayAssay CDL KolkataCDSCO lab Apr 2019
PANTOPRAZOLE GASTRO- RESISTANT TABLETS IP 40 MG Batch TJPE802Mfg Mar 2018 · Exp Feb 2020 DissolutionDissolution RDTL ChandigarhCDSCO lab Apr 2019

Right of reply. Manufacturers may submit a response or a laboratory re-test result; it is published unedited alongside this record. Submit a response.