Ingredient record · Reduces bleeding
Tranexamic acid: 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
3 entries containing Tranexamic acid are on India's banned-drugs list, and 2 are banned today. 17 batches of medicines containing Tranexamic acid failed a government lab test between April 2019 and July 2026, from 17 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
2
Banned combinations in force
1
Other listed orders (stayed, restricted, quashed)
17
Batches failed a lab test
Jul 2026
Latest lab alert
On the banned-drugs list
Tranexamic acid 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 |
|---|---|---|---|---|---|
| Tranexamic Acid + Mefenamic Acid + Vitamin K1Fixed-dose combination · painkillers | Banned | S.O. 3344(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Tranexamic Acid + ProanthocyanidinFixed-dose combination · other | Banned | S.O. 4406(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Tranexamic Acid + ProanthocyanidinFixed-dose combination · other | Quashed | S.O. 734(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.
| Product | Batches | Makers | Latest |
|---|---|---|---|
| Tranexamic Acid | 14 | 14 | Jul 2026 |
| Trenaxa Tranexamic Acid | 2 | 2 | Nov 2024 |
| Tranexamic Acid Mefenamic | 1 | 1 | Jan 2024 |
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Tranexamic Acid Injection IP | TRI2502Mfg 2026-02 · Exp 2028-01 | Blitz Pharmaceuticals Pvt. Ltd | The sample does not conform to I.P. with respect to test for Particulate matter and is also not of standard quality for the reason stated under DescriptionDescription | CDL, KolkataCDSCO lab | Jul 2026 |
| Tranexamic Acid Injection I.P, | TG-156Mfg 2025-08 · Exp 2027-07 | Marc Laboratories Ltd. (Unit III)Himachal Pradesh | The sample received does not conform to I.P. 2022 specification with respect to the test for bacterial endotoxins only.Bacterial endotoxins | CDTL, HyderabadCDSCO lab | Feb 2026 |
| Tranexamic Acid Injection IP 500 mg/5ml | Z24-185Mfg 2024-02 · Exp 2026-01 | Zee Laboratories LtdHimachal Pradesh | Related Substances and Assay of Tranexamic AcidAssay | CDL KolkataCDSCO lab | Jun 2025 |
| Tranexamic Acid Tablets IP (Trenaxa 500 ) | 18242021AMfg 2024-08 · Exp 2027-07 | Macleods Pharmaceuticals LtdSikkim | Spurious Identification and Assay of Tranexamic AcidAssay | CDL, KolkataCDSCO lab | May 2025 |
| Tranexamic Acid Injection I.P. (Tranexacure Injection ) | TC-038Mfg 2024-12 · Exp 2026-11 | Pharma Cure LaboratoriesPunjab | Particulate Matter and DescriptionDescription | CDL, KolkataCDSCO lab | Mar 2025 |
| Tranexamic Acid Tablets IP 500 mg (Clip 500 ) | 054A003Mfg 2024-01 · Exp 2025-12 | FDC Limited L-56 & L-57Goa | Related SubstancesRelated substances | CDL KolkataCDSCO lab | Dec 2024 |
| Trenaxa Inj. [ Tranexamic Acid Inj. IP] | TNA2407Mfg 2024-03 · Exp 2026-02 | SanjIvaniParantera l LtdMaharashtra | It fails the test ?Sterility? as per IPSterility | DTL ThiruvananthapuramState lab | Nov 2024 |
| Trenaxa Inj. [Tranexamic Acid injection I.P] | TNA2407Mfg 2024-03 · Exp 2026-02 | Sanjivani Paranteral LtdMaharashtra | It fails the test Sterility as per IPSterility | DTL ThiruvananthapuramState lab | Oct 2024 |
| Tranexamic Acid Injection IP (Stopmust Injection) | KEI-110CMfg 2023-11 · Exp 2025-10 | Elvia Care Pvt. LtdHimachal Pradesh | Bacterial Endotoxins TestBacterial endotoxins | RDTL GuwahatiCDSCO lab | Jul 2024 |
| Tranexamic Acid Tablets I.P. 500 mg | GT31022Mfg 2024-01 · Exp 2025-12 | OMEGA PHARMA KhasraNo.-482Uttarakhand | Related substancesRelated substances | CDTL MumbaiCDSCO lab | Jun 2024 |
| Tranexamic Acid Injection IP (GYNAEPIL Injection) | ANO43004 RMfg 2023-08 · Exp 2025-07 | Psychotropics India LtdUttarakhand | Description, Related Substances & Particulate MatterDescription | CDL KolkataCDSCO lab | Apr 2024 |
| Tranexamic Acid Injection I.P. (Tranexica) | SAI-14764Mfg 2022-03 · Exp 2024-02 | Sunvet HealthcareHimachal Pradesh | pHpH | CDL KolkataCDSCO lab | Feb 2024 |
| Tranexamic Acid & Mefenamic Acid Tablets (Trancycle-MF) | DMT1127Mfg 2023-08 · Exp 2025-07 | Dm Pharma Private LimitedHimachal Pradesh | AssayAssay | CDTL HyderabadCDSCO lab | Jan 2024 |
| Tranexamic Acid Tablets IP 250 mg (TYRODIN TABLETS ) | T0164Mfg 2020-12 · Exp 2022-11 | Canixa Life Sciences Pvt. LtdUttarakhand | Related SusbtancesOther | RDTL ChandigarhCDSCO lab | Apr 2021 |
| TRANEXAMIC ACID TABLETS IP | T2002047Mfg 2020-02 · Exp 2022-01 | Rhydburg Pharmaceuticals LtdUttarakhand | Related SubstancesRelated substances | RDTL ChandigarhCDSCO lab | Apr 2021 |
Showing 15 of 17 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.