Ingredient record · Acid reducer (H2 blocker)
Ranitidine: 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
17 entries containing Ranitidine are on India's banned-drugs list, and 11 are banned today. 30 batches of medicines containing Ranitidine failed a government lab test between February 2019 and June 2026, from 26 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
11
Banned combinations in force
6
Other listed orders (stayed, restricted, quashed)
30
Batches failed a lab test
Jun 2026
Latest lab alert
Is it banned? Our answer pages
Not banned · molecule under review
Not banned · under DTAB review
Not banned · molecule under review
Not banned · maker paused (being verified)
On the banned-drugs list
Ranitidine 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 |
|---|---|---|---|---|---|
| Ranitidine + Dicyclomine + Clidinium BromideFixed-dose combination · gi | Banned | S.O. 207(E) | 11 January 2019 | Other orders | One of 80 FDCs prohibited vide S.O. 180(E)-259(E) dated 11.01.2019 (CDSCO letter 22.01.2019). In force per CDSCO list as on 22.11.2021. |
| Ranitidine + OmeprazoleFixed-dose combination · gi | Banned | S.O. 208(E) | 11 January 2019 | Other orders | One of 80 FDCs prohibited vide S.O. 180(E)-259(E) dated 11.01.2019 (CDSCO letter 22.01.2019). In force per CDSCO list as on 22.11.2021. |
| Ranitidine + Dicyclomine + NimesulideFixed-dose combination · gi | Banned | S.O. 249(E) | 11 January 2019 | Other orders | One of 80 FDCs prohibited vide S.O. 180(E)-259(E) dated 11.01.2019 (CDSCO letter 22.01.2019). In force per CDSCO list as on 22.11.2021. |
| Ranitidine + Dicycloverine + SimethiconeFixed-dose combination · gi | Banned | S.O. 250(E) | 11 January 2019 | Other orders | One of 80 FDCs prohibited vide S.O. 180(E)-259(E) dated 11.01.2019 (CDSCO letter 22.01.2019). In force per CDSCO list as on 22.11.2021. |
| Ranitidine + DrotaverineFixed-dose combination · gi | Banned | S.O. 251(E) | 11 January 2019 | Other orders | One of 80 FDCs prohibited vide S.O. 180(E)-259(E) dated 11.01.2019 (CDSCO letter 22.01.2019). In force per CDSCO list as on 22.11.2021. |
| Paracetamol + Mefenamic Acid + Ranitidine + DicyclomineFixed-dose combination · gi | Banned | S.O. 4401(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Magaldrate + Ranitidine + Pancreatin + DomperidoneFixed-dose combination · gi | Banned | S.O. 4499(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Ranitidine + Magaldrate + SimethiconeFixed-dose combination · gi | Banned | S.O. 4500(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Ranitidine + Domperidone + SimethiconeFixed-dose combination · gi | Banned | S.O. 4504(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Ranitidine + MagaldrateFixed-dose combination · gi | Banned | S.O. 4509(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Levocetirizine + RanitidineFixed-dose combination · cough-cold | Banned | S.O. 4547(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Paracetamol + Mefenamic Acid + Ranitidine + DicyclomineFixed-dose combination · gi | Quashed | S.O. 729(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Magaldrate + Ranitidine + Pancreatin + DomperidoneFixed-dose combination · gi | Quashed | S.O. 836(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Ranitidine + Magaldrate + SimethiconeFixed-dose combination · gi | Quashed | S.O. 837(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Ranitidine + Domperidone + SemithiconeFixed-dose combination · gi | Quashed | S.O. 841(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Ranitidine + MagaldrateFixed-dose combination · gi | Quashed | S.O. 846(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Levocetirizine + RanitidineFixed-dose combination · cough-cold | Quashed | S.O. 885(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 |
|---|---|---|---|
| Ranitidine | 14 | 12 | Jun 2026 |
| Ranitidine Hydrochloride | 8 | 8 | Jun 2026 |
| Ondansetron Ranitidine Hci Vomibac R | 1 | 1 | Dec 2025 |
| Ranitidine Zaltac | 1 | 1 | Dec 2025 |
| Aciloc Ranitidine | 1 | 1 | Sep 2022 |
| Ranitidine /ml | 1 | 1 | Nov 2020 |
| Ranius | 1 | 1 | Sep 2020 |
| Radin | 1 | 1 | Jan 2020 |
| Aztec | 1 | 1 | Feb 2019 |
| Ranitac | 1 | 1 | Feb 2019 |
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Ranitidine Oral Solution IP | RAN191Mfg 2025-07 · Exp 2027-06 | Revive Formulation India PvtTamil Nadu | ContentOther | DTL, Madurai-19State lab | Jun 2026 |
| Ranitidine Oral Solution IP | L5E068Mfg 2025-05 · Exp 2027-04 | Samyan Health Care Pvt. LtdHimachal Pradesh | Sample does not conform to IP standards with respect to AssayAssay | DTL, ThrissurState lab | Jun 2026 |
| Ranitidine HCL I.P. 150 mg). | 25S007B01Mfg 2025-10 · Exp 2027-09 | Daundi Biological Pvt. LtdUttarakhand | Storage - Does not comply with I.P.Other | SDFTL US Nagar,UKState lab | Jun 2026 |
| Ranitidine Hydrochloride Tablets IP 150mg | RDT24029Mfg 2024-06 · Exp 2026-05 | Vivek Pharmachem (India) LtdRajasthan | DescriptionDescription | DTL, KonniState lab | Mar 2026 |
| Ranitidine Hydrochloride Tablets IP 150 mg | TMG-240616Mfg 2024-03 · Exp 2026-02 | Prochem Pharmaceuticals Pvt. LtdUttarakhand | The sample does not conform to I.P. with respect to DescriptionDescription | CDL, KolkataCDSCO lab | Mar 2026 |
| Ranitidine Oral Solution IP ZALTAC Syrup | MDL-C490Mfg 2025-08 · Exp 2027-07 | Marvellon Pharmaceuticals Pvt. Ltd. Kh. No. 114Himachal Pradesh | The sample does not conform to claim as per IP 2022 in respect to The test pH and Assay of Ranitidine Hydrochloride calculated as Ranitidine.Assay | RDTL, ChandigarhCDSCO lab | Dec 2025 |
| Ondansetron and Ranitidine HCI Injection Vomibac R Injection | 110525Mfg 2025-05 · Exp 2027-04 | Pharma Chemico Laboratories DevghatHimachal Pradesh | The sample received does not conform to manufacturer specification with respect to The test for pH only.pH | CDTL-HyderabadCDSCO lab | Dec 2025 |
| Ranitidine Oral Solution IP | SR-017Mfg 2024-06 · Exp 2026-05 | Sresan Pharmaceutical ManufacturerKarnataka | This particular batch of sample fails the test Assay of Ranitidine.Assay | RDTL ErnakulamState lab | Nov 2025 |
| Ranitidine Oral Solution IP | AL24011221DMfg 2024-01 · Exp 2025-12 | Accura Care Pharmaceuticals Pvt. LtdHimachal Pradesh | Content of RanitidineOther | SDT&RL, BhubaneswarState lab | Nov 2025 |
| Ranitidine Hydrochloride Tablets IP 150mg | AZCT-2505Mfg 2025-05 · Exp 2027-04 | Seldom Pharma Pvt. LtdPuducherry | Circular orange colored, biconvex plain on both sides. Two types of colored tablets observed while opening from the strips. Some tablets are light brown colored and some tablets are orange colored, hence Description (Appearance) test parameter does not complies as per IP specification.Description | DCL TelanganaState lab | Nov 2025 |
| Ranitidine Injection IP-2ML | HLI352CMfg 2024-03 · Exp 2026-02 | Himalaya Meditek Pvt. LtdUttarakhand | Sample does not conform to requirement for AssayAssay | King Institute of Preventive Medicine & Research, Guindy, Chennai-32State lab | May 2025 |
| Ranitidine Hydrochloride Tablets IP 150mg (Zeptiloc-150 tablets) | ZCI24003Mfg 2024-04 · Exp 2026-03 | Danish Healthcare (P) Ltd. 76/27-28 | DescriptionDescription | State Drugs Laboratory, PunjabState lab | May 2025 |
| Ranitidine Hydrochloride Injection I.P | AV3082Mfg 2023-02 · Exp 2025-01 | Alpa Laboratories LtdMadhya Pradesh | Test for SterilitySterility | State Lab KarnatakaState lab | Dec 2024 |
| Ranitidine Hydrochloride Tablets (Ranylaj-150) | GTDE3019Mfg 2023-05 · Exp 2025-04 | Francis Remdies (India) Pvt.LtdUttarakhand | DescriptionDescription | CDL KolkataCDSCO lab | Jun 2024 |
| Ranitidine Tablets I.P. 150 mg | 404423Mfg 2023-05 · Exp 2025-04 | Karnataka Antibiotics & Pharmaceuticals LtdKarnataka | DescriptionDescription | CDL KolkataCDSCO lab | Mar 2024 |
Showing 15 of 30 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.