Ingredient record · Painkiller (NSAID)
Aceclofenac: bans, restrictions and failed batches in India
Last checked 20 September 2026. Sources: CDSCO banned-drugs notifications and monthly NSQ alerts, Jan 2019 to Jul 2026
11 entries containing Aceclofenac are on India's banned-drugs list, and 6 are banned today. 117 batches of medicines containing Aceclofenac failed a government lab test between February 2019 and July 2026, from 102 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
6
Banned combinations in force
5
Other listed orders (stayed, restricted, quashed)
117
Batches failed a lab test
Jul 2026
Latest lab alert
Is it banned? Our answer pages
Enzyme not banned · 4 combos banned
Not banned · paediatric strength banned
Not banned · watch list
On the banned-drugs list
Aceclofenac on its own is not on CDSCO's banned list. The entries below are specific combinations that contain it. Status follows CDSCO's own notes on each entry.
| Drug / combination | Action | Notification | Date | Order | Status note |
|---|---|---|---|---|---|
| Sucralfate + AceclofenacFixed-dose combination · gi | Banned | S.O. 3300(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Aceclofenac 50mg + Paracetamol 125mg Oral LiquidFixed-dose combination · painkillers | Banned | S.O. 3408(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Aceclofenac 50mg + Paracetamol 125mg TabletFixed-dose combination · painkillers | Banned | S.O. 3409(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Aceclofenac + Paracetamol + RabeprazoleFixed-dose combination · painkillers | Quashed | S.O. 4379(E) | 7 September 2018 | 328 FDCs · Sep 2018 | Quashed by Delhi HC order dated 13.03.2019; CDSCO appealed, sub judice (CDSCO list as on 22.11.2021, note 5#). |
| Aceclofenac + Paracetamol + FamotidineFixed-dose combination · painkillers | Banned | S.O. 4414(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Aceclofenac + Zinc CarnosineFixed-dose combination · painkillers | Banned | S.O. 4415(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Aceclofenac (SR) + ParacetamolFixed-dose combination · painkillers | Banned | S.O. 4420(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Aceclofenac + Paracetamol + RabeprazoleFixed-dose combination · painkillers | Quashed | S.O. 705(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Aceclofenac + Paracetamol + FamotidineFixed-dose combination · painkillers | Quashed | S.O. 744(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Aceclofenac + Zinc CarnosineFixed-dose combination · painkillers | Quashed | S.O. 745(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Aceclofenac (SR) + ParacetamolFixed-dose combination · painkillers | Quashed | S.O. 750(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
Products that failed lab tests
Product names as printed by the testing labs, grouped. Open a product to see every batch number.
Top 30 of 36 products by number of batches.
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Aceclofenac, Paracetamol and Serratiopeptidase Tablets | F9AHY065Mfg 2025-10 · Exp 2027-09 | Pharma Force Lab 53-55Himachal Pradesh | Identity test negative for Aceclofenac and Content of ParacetamolOther | Lucknow LabState lab | Jul 2026 |
| Aceclofenac, Paracetamol & Serratiopeptidase Tablets | TG25-1919BMfg 2025-10 · Exp 2027-09 | Menrik Biomerge Pvt. Ltd. 5Delhi | Content of AceclofenacOther | GORAKHPUR LAB, UPState lab | Jul 2026 |
| Aceclofenac and Parcetamol IP) | T251733CMfg 2025-09 · Exp 2027-08 | Bajaj FormulationsUttarakhand | 01. ASSAY OF ACECLOFENAC I.P. ?Less than prescribed limit.Assay | SFDTL UttarakhandState lab | Jul 2026 |
| Aceclofenac Sustained Release and Enteric Coated Rabeprazole Sodium Capsules | C50200BMfg 2025-12 · Exp 2027-11 | Samson Laboratories Pvt. LtdHimachal Pradesh | The sample received does not conform to manufacturers specification with respect to the test for Assay of rabeprazole sodium content only.Assay | CDTL, HyderabadCDSCO lab | Jul 2026 |
| Aceclofenac 100 mg, Serratiopeptidase 15 mg & Paracetamol 325 mg Tablets | FND0825055AKMfg 2025-12 · Exp 2028-05 | Ipca Laboratories LtdSikkim | Identity test negative for Aceclofenac and ParacetamolOther | Lucknow LabState lab | Jul 2026 |
| Aceclofenac & Paracetamol Tablets IP | MT250239Mfg 2025-06 · Exp 2028-05 | Oxford PharmaUttarakhand | Content of Aceclofenac (82.94%)Other | Drugs Testing Laboratory, Madurai-19State lab | Jul 2026 |
| Aceclofenac & Paracetamol Tablets IP | T-2504296Mfg 2025-04 · Exp 2028-03 | Gopal LifesciencesHimachal Pradesh | DissolutionDissolution | Lucknow LabState lab | Jul 2026 |
| Aceclofenac & Paracetamol Tablets | T2601006/AMfg 2026-01 · Exp 2028-12 | Empree Medicament India Pvt. Ltd | Does not conform to IP Standards with respect to Dissolution TestDissolution | Food & Drugs Laboratory Bambolim, GoaState lab | Jul 2026 |
| Aceclofenac & Paracetamol Tablets | BLPT-053Mfg 2026-04 · Exp 2028-03 | Bonn Stering Bio Science LLPPuducherry | Content of Aceclofenac (81.98%) and Paracetamol (81.62%)Other | Drugs Testing Laboratory, Madurai-19State lab | Jul 2026 |
| Aceclofenac, Paracetamol & Serratiopeptidase Tablets | FND0826009AKMfg 2026-02 · Exp 2028-07 | Ipca Laboratories LtdUttarakhand | Description Rough surface on each Tablets.Description | SDFTL US Nagar,UKState lab | Jun 2026 |
| Aceclofenac and Paracetamol | T251109Mfg 2025-11 · Exp 2027-10 | Medisky Pharmaceuticals Pvt. Ltd | MisbrandadMisbranded | SDTL,ChhattisgarhState lab | Jun 2026 |
| Aceclofenac and Paracetamol | ET25246Mfg 2025-12 · Exp 2028-11 | Edkem Pharmaceuticals LtdGujarat | MisbrandadMisbranded | SDTL,ChhattisgarhState lab | Jun 2026 |
| Aceclofenac and Paracetamol | SPT251764AMfg 2025-08 · Exp 2027-07 | Salus Pharmaceuticals Als 480/21 Harraipur PO Gaunmajara Tah- Baddi Distt- Solan (H.P.) 173205Himachal Pradesh | MisbrandadMisbranded | SDTL,ChhattisgarhState lab | Jun 2026 |
| Aceclofenac & Paracetamol Tablets I.P. | 5725004Mfg 2025-03 · Exp 2028-02 | Leeford Healthcare LtdHimachal Pradesh | Description Rough surface on each Tablets.Description | SDFTL US Nagar,UKState lab | Jun 2026 |
| Aceclofenac, Paracetamol, Phenylephrine Hcl Cetirizine Hcl & Caffeine | GT-25294AMfg 2025-08 · Exp 2028-07 | Not applicable | MisbrandadMisbranded | SDTL, ChhattisgarhState lab | May 2026 |
Showing 15 of 117 records
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