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Ursodeoxycholic 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
4 entries containing Ursodeoxycholic acid are on India's banned-drugs list, and 3 are banned today. 6 batches of medicines containing Ursodeoxycholic acid failed a government lab test between December 2019 and July 2025, from 6 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
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 | 6 | 6 | Jul 2025 |
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Ursodeoxycholic Acid Tablets IP | MDT-3717Mfg 2025-01 · Exp 2026-12 | Mayasha Lifesciences H.B. 86Himachal Pradesh | Dissolution and Assay.Assay | CDTL, MumbaiCDSCO lab | Jul 2025 |
| Ursodeoxycholic acid Tablets IP 300 mg | UDS-501Mfg 2024-08 · Exp 2026-07 | 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) | MT223471Mfg 2022-07 · Exp 2024-06 | Mascot Health Series Pvt. LtdUttarakhand | DescriptionDescription | CDL KolkataCDSCO lab | Oct 2023 |
| Ursodeoxycholic Acid Tablets IP 300 mg (BAKLIV-300 TABLETS) | TF2037AMfg 2022-06 · Exp 2024-05 | 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) | 250923D7Mfg 2021-01 · Exp 2023-05 | Abbott India LimitedGoa | Identification and AssayAssay | RDTL GuwahatiState lab | Apr 2022 |
| Ursodeoxycholic Acid Tablets IP 300 mg ( UDILIV 300 TABLETS) | 010924D7Mfg 2019-01 · Exp 2021-01 | 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.