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Ursodeoxycholic acid: 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
4 entries containing Ursodeoxycholic acid are on India's banned-drugs list, and 3 are banned today. 8 batches of medicines containing Ursodeoxycholic acid failed a government lab test between December 2019 and September 2026, from 8 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
Is it banned? Our answer pages
On the banned-drugs list
Ursodeoxycholic 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 |
|---|---|---|---|---|---|
| S-Adenosyl Methionine + Metadoxine + Ursodeoxycholicacid BP + L-Methylfolate Calcium eq. to L- Methylfolate + Choline Bitartratee + Silymarin + L-Ornithine Laspartate + Inositol + TaurineFixed-dose combination · vitamins | Banned | S.O. 3295(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Ursodeoxycholic Acid + Metformin HClFixed-dose combination · diabetes | Banned | S.O. 3304(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Ursodeoxycholic Acid + SilymarinFixed-dose combination · gi | Banned | S.O. 4466(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Ursodeoxycholic Acid + SilymarinFixed-dose combination · gi | Quashed | S.O. 801(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 |
|---|---|---|---|
| Ursodeoxycholic Acid | 8 | 8 | Sep 2026 |
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Ursodeoxycholic Acid Tablets IP 300 mg | Batch DT605068Mfg May 2026 · Exp Apr 2028 | Renowed LifesciencesUttarakhand | The sample does not conform to I.P. in respect of Assay.Assay | LUCKNOW, Uttar PradeshState lab | Sep 2026 |
| Ursodeoxycholic Acid Tablets IP | Batch GTF3302AMfg Nov 2024 · Exp Oct 2026 | Sun Pharma Laboratories LtdAssam | TEST FOR ASSAY (CONTENT) OF URSODEOXYCHOLIC ACID.Assay | DTL, DelhiState lab | Sep 2026 |
| Ursodeoxycholic Acid Tablets IP | Batch MDT-3717Mfg Jan 2025 · Exp Dec 2026 | Mayasha Lifesciences H.B. 86Himachal Pradesh | Dissolution and Assay.Assay | CDTL, MumbaiCDSCO lab | Jul 2025 |
| Ursodeoxycholic acid Tablets IP 300 mg | Batch UDS-501Mfg Aug 2024 · Exp Jul 2026 | Healers Lab Unit IIHimachal Pradesh | The sample does not confirm to claim as per IP 2022 in respect to the Dissolution of Ursodiol (Ursodeoxycholic Acid)Dissolution | DTL Baddi Distt. SolanState lab | May 2025 |
| Ursodeoxycholic Acid Tablets IP (Mascholic- 300) | Batch MT223471Mfg Jul 2022 · Exp Jun 2024 | Mascot Health Series Pvt. LtdUttarakhand | DescriptionDescription | CDL KolkataCDSCO lab | Oct 2023 |
| Ursodeoxycholic Acid Tablets IP 300 mg (BAKLIV-300 TABLETS) | Batch TF2037AMfg Jun 2022 · Exp May 2024 | Navkar Lifesciences WHO-GMP Certified CompanyHimachal Pradesh | Identification A, Identification B and AssayAssay | RDTL ChandigarhCDSCO lab | Aug 2022 |
| Ursodeoxycholic Acid Tablets IP 300mg (Udiliv 300) | Batch 250923D7Mfg Jan 2021 · Exp May 2023 | Abbott India LimitedGoa | Identification and AssayAssay | RDTL GuwahatiState lab | Apr 2022 |
| Ursodeoxycholic Acid Tablets IP 300 mg (UDILIV 300 TABLETS) | Batch 010924D7Mfg Jan 2019 · Exp Jan 2021 | Allegedly Mfd by: M/s. Abbott India LimitedGoa | IdentificationIdentification | RDTL ChandigarhState lab | Dec 2019 |
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.