Ingredient record · Painkiller (NSAID)
Aceclofenac: bans, restrictions and failed batches in India
Last checked 3 November 2026. Sources: CDSCO banned-drugs notifications and monthly NSQ alerts, Jan 2019 to Sep 2026
11 entries containing Aceclofenac are on India's banned-drugs list, and 6 are banned today. 127 batches of medicines containing Aceclofenac failed a government lab test between February 2019 and September 2026, from 108 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)
127
Batches failed a lab test
Sep 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 38 products by number of batches.
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Aceclofenac, Paracetamol &Chlorozoxazone Tablets | Batch HT25871Mfg Dec 2025 · Exp Nov 2027 | Habitare Pharma Pvt.LtdHimachal Pradesh | Sample FENELA-MR tablets does not comply test for Disintegration as per IP 2022Disintegration | State Lab, DCL, TelanganaState lab | Sep 2026 |
| Aceclofenac, Paracetamol & Serratiopeptidase Tablets) | Batch TG25-2242FMfg Dec 2025 · Exp Nov 2027 | Athens Life SciencesHimachal Pradesh | The Content of Serratiopeptidase in the Sample is less (i.e. 32.33% of Stated Amount) than Schedule V Limit. (Schedule V Limit:- Not less than 90% of Stated Amount)Other | FDAL, M. S Chhatrapatri Sambhajinagar, F.D.A Mahrasthra StateState lab | Sep 2026 |
| Aceclofenac, Paracetamol & Chlorzoxazone Tablets | Batch AT25-0938AMfg Nov 2025 · Exp Oct 2027 | Aspo Pharmaceuticals LLPHimachal Pradesh | The sample does not conform to declared formula, in respect of content of Aceclofenac.Other | LUCKNOW, Uttar PradeshState lab | Sep 2026 |
| Aceclofenac and Paracetamol Tablets | Batch T24K557CMfg Nov 2024 · Exp Oct 2026 | Bajaj FormulationsUttarakhand | TESTS FOR UNIFORMITY OF WEIGHT.Uniformity of weight/content | DTL, DelhiState lab | Sep 2026 |
| Aceclofenac Tablets IP 100mg | Batch M26800003Mfg Mar 2026 · Exp Feb 2028 | Dr.Miltons Laboratories Private Limited | DescriptionDescription | Drug Testing Laboratory, Madurai-19State lab | Sep 2026 |
| Aceclofenac & Paracetamol Tablets | Batch UT260046Mfg Apr 2026 · Exp Mar 2028 | VADSP PharmaceuticalsHimachal Pradesh | content- ParacetamolOther | Drug Testing Laboratory, Madurai-19State lab | Sep 2026 |
| Aceclofenac, Paracetamol & Seratiopeptidase Tablets | Batch DT-06456Mfg Aug 2025 · Exp Jul 2027 | Dual HealthcareHimachal Pradesh | The sample does not conform to declared formula, in respect of Content of Paracetamol & AceclofenacOther | LUCKNOW LABState lab | Aug 2026 |
| Aceclofenac, Paracetamol & Seratiopeptidase Tablets | Batch MDT-4635Mfg Nov 2025 · Exp Oct 2027 | Mayasha Lifesciences H.B. 86Himachal Pradesh | The sample does not conform to declared formula, in respect of Content of Paracetamol & AceclofenacOther | LUCKNOW LABState lab | Aug 2026 |
| Aceclofenac 100mg, Serratiopeptidase 15mg & Paracetamol 325mg Tablets | Batch FND0725001BHMfg Jan 2025 · Exp Jun 2027 | Ipca Laboratories LtdSikkim | The sample does not conform to claim with respect to Identification and Assay/content of Aceclofenac, Paracetamol and Serratiopeptidase activity.Assay | CDL, KolkataCDSCO lab | Aug 2026 |
| Aceclofenac & Paracetamol Tablets | Batch T-22573Mfg Sep 2025 · Exp Aug 2028 | Jakson Laboratories Pvt. Ltd | DescriptionDescription | RDTL, Bellary, KarnatakaState lab | Aug 2026 |
| Aceclofenac, Paracetamol and Serratiopeptidase Tablets | Batch F9AHY065Mfg Oct 2025 · Exp Sep 2027 | Pharma Force Lab 53-55Himachal Pradesh | Identity test negative for Aceclofenac and Content of ParacetamolOther | Lucknow LabState lab | Jul 2026 |
| Aceclofenac, Paracetamol & Serratiopeptidase Tablets | Batch TG25-1919BMfg Oct 2025 · Exp Sep 2027 | Menrik Biomerge Pvt. Ltd. 5Delhi | Content of AceclofenacOther | GORAKHPUR LAB, UPState lab | Jul 2026 |
| Aceclofenac and Parcetamol IP) | Batch T251733CMfg Sep 2025 · Exp Aug 2027 | 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 | Batch C50200BMfg Dec 2025 · Exp Nov 2027 | 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 | Batch FND0825055AKMfg Dec 2025 · Exp May 2028 | Ipca Laboratories LtdSikkim | Identity test negative for Aceclofenac and ParacetamolOther | Lucknow LabState lab | Jul 2026 |
Showing 15 of 127 records
Holding a strip or bottle? The batch number is printed after "B. No." Check it against every alert. If it matches, return it to the pharmacy. What the labels mean: status guide.