Product record

Diclofenac Sodium: batches declared Not of Standard Quality

Last checked 20 September 2026. Source: CDSCO monthly NSQ alerts, Jan 2019, Jul 2026

38 batches of products named "Diclofenac Sodium" (as printed by the testing lab) failed a CDSCO or state drug-testing laboratory test between July 2019 and July 2026. This is a record of specific batches, it does not mean the molecule or every brand is unsafe.

Records by type

38 records linked to Diclofenac Sodium 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
38Failed 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, Jul 2019 to Jul 2026

View original document

Scope. A failed batch is not a verdict on every pack of this product. 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 Always check the linked government document for the current position, and tell us if something is out of date.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.

38
NSQ batches
27
Manufacturers
Description
Most common reason
Jul 2026
Latest alert

Flagged batches

Batch Manufacturer Reason declared NSQ Tested by Alert
SP250935Mfg 2025-09 · Exp 2027-08 Sharun Pharmaceuticals Pvt.LtdPuducherry DissolutionDissolution Drugs Testing Laboratory, Chennai-06State lab Jul 2026
SP250934Mfg 2025-09 · Exp 2027-08 Sharun Pharmaceuticals Pvt.LtdPuducherry DissolutionDissolution Drugs Testing Laboratory, Chennai-06State lab Jul 2026
DG 5033Mfg 2025-03 · Exp 2027-02 Kerala State Drugs Pharmaceuticals LtdKerala The sample does not conform to IP standards with respect to the test Dissolution and also shows Category B defect of tablets (Capping).Dissolution DTL, ThrissurState lab Jul 2026
ZYCD15018Mfg 2025-10 · Exp 2027-09 Laborate Pharmaceuticals India Ltd. 111Himachal Pradesh Content of Diclofenac SodiumOther KANPUR LAB, UPState lab Jul 2026
DG 5031Mfg 2025-02 · Exp 2027-01 Kerala State Drugs and Pharmaceuticals LtdKerala Dissolution.Dissolution DTL ThiruvananthapuramState lab May 2026
PGY25252Mfg 2025-04 · Exp 2027-03 Affy Parenterals Vill Gulerwa;laHimachal Pradesh The sample does not conform to IP 2022 requirements w.r.t pHpH DTL,Dalgate Srinagar kashmirState lab May 2026
VB/LEF0789Mfg 2025-07 · Exp 2027-06 Venus Bio Sciences Pvt. LtdHimachal Pradesh The sample does not conform to I.P. with respect to the tests of Identification and Assay of Diclofenac Sodium. The sample gives positive test for Identification of Buprenorphine. The sample is deemed to be spurious vide section 17 B of Drugs and Cosmetics Act 1940 and Rule 1945.Assay CDL, KolkataCDSCO lab Apr 2026
DG5028Mfg 2025-02 · Exp 2027-01 Kerala State Drugs and Pharmaceuticals LtdKerala Dissolution as per IPDissolution DTL, ThrissurState lab Mar 2026
VB/LEF0789Mfg 2025-07 · Exp 2027-06 Venus Bio Sciences Pvt. LtdHimachal Pradesh The sample does not conform to I.P. with respect to the tests of Identification and Assay of Diclofenac Sodium.Assay CDL, KolkataCDSCO lab Mar 2026
2507017Mfg 2025-03 · Exp 2027-02 Neon Laboratories Ltd.at Plot No.G84/1 The sample does not conform to I.P w.r.t the test for Description and Particulate matterDescription DTL, Dalgate Srinagar Kashmir (J & K)State lab Feb 2026
2507017Mfg 2025-03 · Exp 2027-02 Neon Laboratories Ltd.at Plot No.G84/1 Thesample does not conform to I.P w.r.t the test for Description and Particulate matterDescription DTL, Dalgate Srinagar Kashmir ( J and K)State lab Jan 2026
B250895Mfg 2025-06 · Exp 2027-05 Bochem Healthcare Pvt. Ltd Dissolution (Buffer stage)Dissolution Food & Drugs Laboratory, VadodaraState lab Nov 2025
G25RDA016Mfg 2025-03 · Exp 2027-02 Acme Generics Pvt. Ltd. Plot no. 115 HPSIDCHimachal Pradesh Sample fail the test DissolutionDissolution DTL, Thiruvananthapuram, KeralaState lab Oct 2025
DT24-62Mfg 2024-10 · Exp 2026-09 Leostar Healthcare Pvt. Ltd. Sy No. 321Telangana Disintegration and DescriptionDescription DCL TelanganaState lab Oct 2025
P25L265Mfg 2025-02 · Exp 2027-01 Paksons Pharmaceuticals Private LimitedHaryana Extractable VolumeExtractable volume CDL KolkataCDSCO lab Jun 2025
CDTP-265Mfg 2024-09 · Exp 2026-08 Candor Biotech LtdPunjab The sample does not conform to the IP with respect Assay of Diclofenac Sodium (NIL) and Found Aceclofenac (57.41 mg/Tab)Assay DTL,Jaipur (State Lab)State lab May 2025
THB24028ALMfg 2024-07 · Exp 2026-06 Hindustan Laboratories LimitedMaharashtra Sample does not conform to IP specification for Enteric Coated Tablets with respect to DisintegrationDisintegration DTL ChennaiState lab Apr 2025
DT23- 38Mfg 2023-12 · Exp 2025-11 Leostar Healthcare Pvt. Ltd Sy No. 321 NOT OF STANDARD QUALITY 1. While opening the strip, it is found that the tablets are not in intact condition. Hence sample is of Not of Standard Quality with respect to Description test parameter. 2. Disintegration test does not complies since the tablets disintegrated in acid medium completely. But as per IP the coating of the enteric coated should be in intact condition in acid medium. Hence sample is of Not of Standerd Quality with respect to Disintegration test parameter.Description State Lab Drugs Control Laboratory, TelanganaState lab Feb 2025
A-1694Mfg 2024-02 · Exp 2026-01 ALCHEMIST REMEDIES PVT. LTD pH , Sterility, Particulate Matter, and AssayAssay RDTL GuwahatiCDSCO lab Jan 2025
SNDA23801Mfg 2023-08 · Exp 2025-07 Srinija Parenterals pHpH CDL KolkataCDSCO lab Jan 2025
HDFA02Mfg 2023-11 · Exp 2025-10 Hindustan Antibiotics LtdHaryana DissolutionDissolution CDL KolkataCDSCO lab Sep 2024
DFS- 2405031Mfg 2024-05 · Exp 2029-04 Sara Exports Ltd. Plot No. 35Uttar Pradesh Not of Standard QualityOther CDTL MumbaiCDSCO lab Aug 2024
I213109Mfg 2023-07 · Exp 2025-06 ANG Lifesciences India LtdHimachal Pradesh DescriptionDescription RDTL GuwahatiState lab Feb 2024
I213108Mfg 2023-07 · Exp 2025-06 ANG Lifesciences India LtdHimachal Pradesh Particulate matter and DescriptionDescription RDTL GuwahatiState lab Jan 2024
DBE14Mfg 2023-03 · Exp 2025-02 RPL (INDIA) Pharmaceuticals Pvt. LtdDelhi DescriptionDescription RDTL ChandigarhCDSCO lab Oct 2023
AT22201Mfg 2022-08 · Exp 2024-07 Alves Healthcare Private LimitedHimachal Pradesh Disintegratio nOther CDL KolkataCDSCO lab Sep 2023
TS7464Mfg 2022-11 · Exp 2024-10 ADROIT PHARMACEUTICALS Pvt. Ltd at: 46Maharashtra Test for Disintegration (Acid Stage)Disintegration CDTL HyderabadCDSCO lab Jun 2023
DSIY-85Mfg 2021-12 · Exp 2023-11 Hindustan Antibiotics LtdHaryana Particulate MatterParticulate matter RDTL ChandigarhCDSCO lab Apr 2023
TS7463Mfg 2022-11 · Exp 2024-10 Adroit Pharmaceuticals Pvt. LtdMaharashtra Disintegration (Acid Stage)Disintegration CDTL HyderabadCDSCO lab Feb 2023
DF11Mfg 2021-07 · Exp 2023-06 Suzikem Drugs Pvt. LtdTelangana Disintegration (Acid Stage)Disintegration CDTL HyderabadCDSCO lab Dec 2021
DSIX-109Mfg 2020-12 · Exp 2022-11 Hindustan Antibiotics LtdHaryana Particulate MatterParticulate matter CDL KolkataCDSCO lab Jun 2021
T2224Mfg 2019-10 · Exp 2021-09 Quest Laboratories Pvt. LtdMadhya Pradesh DisintegrationDisintegration CDTL MumbaiCDSCO lab May 2021
DF-R008Mfg 2019-02 · Exp 2021-01 Bengal Chemicals & Pharmaceuticals LtdMadhya Pradesh DisintegrationDisintegration CDL KolkataCDSCO lab Jan 2020
I-18165Mfg 2018-11 · Exp 2020-10 Jackson Laboratories Pvt. LtdPunjab Description, Particulate Matter & pHDescription CDL KolkataCDSCO lab Dec 2019
1511917Mfg 2017-10 · Exp 2019-09 Karnataka Antibiotics & Pharmaceuticals LtdKarnataka Disintegration & Related SubstancesDisintegration CDL KolkataCDSCO lab Jul 2019
1508318Mfg 2018-05 · Exp 2020-04 Karnataka Antibiotics & Pharmaceuticals LtdKarnataka Related SubstancesRelated substances CDL KolkataCDSCO lab Jul 2019
1512117Mfg 2017-11 · Exp 2019-10 Karnataka Antibiotics & Pharmaceuticals LtdKarnataka Disintegration & Related SubstancesDisintegration CDL KolkataCDSCO lab Jul 2019
I-17507Mfg 2018-07 · Exp 2020-06 Jackson Laboratories Pvt. LtdPunjab Description & Particulate MatterDescription CDL KolkataCDSCO lab Jul 2019

How to use this. Match the batch number on your strip or bottle against the list. If your batch is listed, return it to the pharmacy and ask for a replacement; if not, the product is not on any alert as of July 2026. Check any batch number.