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Sucralfate: 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
7 entries containing Sucralfate are on India's banned-drugs list, and 6 are banned today. 25 batches of medicines containing Sucralfate failed a government lab test between September 2019 and September 2026, from 17 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
6
Banned combinations in force
1
Other listed orders (stayed, restricted, quashed)
25
Batches failed a lab test
Sep 2026
Latest lab alert
Is it banned? Our answer pages
Not banned · some combos banned
On the banned-drugs list
Sucralfate 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. |
| Sucralfate + Domperidone + DimethiconeFixed-dose combination · gi | Banned | S.O. 3301(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Sucralfate + DomperidoneFixed-dose combination · gi | Banned | S.O. 3302(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Sucralfate + Pantoprazole Sodium + Zinc Gluconate + Light Magnesium CarbonateFixed-dose combination · gi | Banned | S.O. 3306(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Sucralfate + Domperidone + SimethiconeFixed-dose combination · gi | Banned | S.O. 3437(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Zinc Carnosine + SucralfateFixed-dose combination · gi | Banned | S.O. 4515(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Zinc Carnosine + SucralfateFixed-dose combination · gi | Quashed | S.O. 852(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 |
|---|---|---|---|
| Sucralfate Oxetacaine | 12 | 10 | Jun 2026 |
| Sucralfate | 8 | 3 | May 2025 |
| Sucralfate Povidone Iodine | 1 | 1 | Sep 2026 |
| Povidone Iodine Sucralfate Oinment | 1 | 1 | Aug 2026 |
| Axid | 1 | 1 | May 2025 |
| Sucralfate Oxetacain | 1 | 1 | Jan 2025 |
| Sucralfate Oxetacaine Gm + | 1 | 1 | Oct 2023 |
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Sucralfate & Povidone-Iodine Ointment | Batch 0F5008AMfg Jun 2025 · Exp May 2027 | Navkar LifesciencesHimachal Pradesh | Assay for Available IodineAssay | DTL, Bengaluru, KarnatakaState lab | Sep 2026 |
| Povidone - Iodine &Sucralfate oinment | Batch 090Mfg Jan 2026 · Exp Dec 2027 | Plus FormulationsUttarakhand | Content - Available Iodine in povidone iodineOther | DTL, Chennai-06State lab | Aug 2026 |
| Sucralfate & Oxetacaine Suspension | Batch SCI-2508Mfg Dec 2025 · Exp Nov 2027 | Apple Formulations Pvt. LtdUttarakhand | ContentOther | DTL, Madurai-19State lab | Jun 2026 |
| Sucralfate, Oxetacaine | Batch AL-24115Mfg Jul 2024 · Exp Jun 2026 | Accretion Pharmaceuticals Ltd. 29Gujarat | Description, Content of OxetacaineDescription | SDT&RL, BhubaneswarState lab | Feb 2026 |
| Sucralfate and Oxetacaine Suspension | Batch L250813Mfg Aug 2025 · Exp Jul 2027 | SGS Formulation Pvt Ltd | ContentOther | Drugs Testing Laboratory, Chennai-06State lab | Nov 2025 |
| Sucralfate & Oxetacaine Suspension | Batch SCO-2503Mfg Jun 2025 · Exp May 2027 | Apple Formulations Pvt. LtdUttarakhand | ContentOther | Drugs Testing Laboratory, Chennai-06State lab | Nov 2025 |
| Sucralfate & Oxetacaine Oral Suspension | Batch JLD25C14AMfg Mar 2025 · Exp Feb 2027 | Jaiwik Biotech (P) LtdRajasthan | ContentOther | Drugs Testing Laboratory, Chennai-06State lab | Nov 2025 |
| Sucralfate & Oxetacaine Oral Suspension(Sucrakars- O Suspension) | Batch RL2412-10Mfg Dec 2024 · Exp Nov 2026 | Regent Ajanta BiotechUttarakhand | Assay of SucralfateAssay | CDL, KolkataCDSCO lab | Jul 2025 |
| Sucralfate Oral Suspension (AXID 200) | Batch 624-470Mfg Jun 2024 · Exp May 2026 | Zee Laboratories Ltd | The sample does not conform to claim standards with respect to descriptionDescription | CDTL- ChennaiCDSCO lab | May 2025 |
| Axid 200 (Sucralfate Oral Suspension) | Batch 624-470Mfg Jun 2024 · Exp May 2026 | Zee Laboratories LtdHimachal Pradesh | Sample does not conform with respect to General requirements for liquid dosage formOther | Drugs Testing Laboratory, Chennai-06State lab | May 2025 |
| Sucralfate & Oxetacaine Suspension (Rabeflux Suspension) | Batch RBLS-02501Mfg Jan 2025 · Exp Dec 2026 | Tidal Laboratories Pvt. Ltd | Identification, Assay of Sucralfate and Assay of OxetacaineAssay | CDL KolkataCDSCO lab | Apr 2025 |
| Sucralfate USP | Batch LSU240 9105Mfg Sep 2024 · Exp Aug 2024 | Legend IndustriesGujarat | Sample does not conforms to U.S.P respect to identification and Assay of Sucralfate.Assay | CDL KolkataState lab | Mar 2025 |
| Sucralfate USP | Batch LSU240 9106Mfg Sep 2024 · Exp Aug 2025 | Legend IndustriesGujarat | Sample does not conforms to U.S.P respect to identification and Assay of Sucralfate.Assay | CDL KolkataState lab | Mar 2025 |
| Sucralfate USP | Batch LSU2409105Mfg Sep 2024 · Exp Aug 2029 | Legend IndustriesGujarat | Spurious Identification and Assay of SucralfateAssay | CDL KolkataCDSCO lab | Feb 2025 |
| Sucralfate and Oxetacain Suspension | Batch SEL2401Mfg Jan 2024 · Exp Dec 2025 | CU-V-Kar Genetic Medicines Pvt LtdUttarakhand | Sample does not conform to Label claim with respect to content of Oxetacaine.Labelling | DTL MaduraiState lab | Jan 2025 |
Showing 15 of 25 records
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