Ingredient record · Anti-diarrhoea medicine
Loperamide: 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 Loperamide are on India's banned-drugs list, and 3 are banned today. 15 batches of medicines containing Loperamide failed a government lab test between May 2019 and June 2026, from 15 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
3
Banned combinations in force
1
Other listed orders (stayed, restricted, quashed)
15
Batches failed a lab test
Jun 2026
Latest lab alert
Is it banned? Our answer pages
Not banned · paediatric limit (being verified)
On the banned-drugs list
Loperamide 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 |
|---|---|---|---|---|---|
| Norfloxacin + Tinidazole + LoperamideFixed-dose combination · antibiotics | Banned | S.O. 201(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. |
| Furazolidone + Metronidazole + LoperamideFixed-dose combination · antibiotics | Banned | S.O. 4507(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Furazolidone + Metronidazole + LoperamideFixed-dose combination · antibiotics | Quashed | S.O. 844(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Loperamide Hydrochloride with FurazolidoneFixed-dose combination · antibiotics | Banned | GSR 170(E) | 12 March 2001 | Classic bans | In force per CDSCO consumer list (1983-2017) |
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 |
|---|---|---|---|
| Loperamide Hydrochloride | 11 | 11 | Jun 2026 |
| Ofloxacin Ornidazole Loperamide Bolus | 1 | 1 | Apr 2026 |
| Loperamide Hci | 1 | 1 | Oct 2025 |
| Lomolok | 1 | 1 | Dec 2022 |
| Sestil Ad | 1 | 1 | Jun 2021 |
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Loperamide Hydrochloride Tablets IP 2mg | 2402Mfg 2025-03 · Exp 2027-02 | Abil Healthcare 311Madhya Pradesh | Failed AssayAssay | DTL, PuducherryState lab | Jun 2026 |
| Ofloxacin 100mg, Ornidazole 2500mg & Loperamide 7.5mg Bolus IP | DF-1677Mfg 2025-09 · Exp 2027-08 | Dutch Formulations 32Himachal Pradesh | Assay of Ofloxacin, Ornidazole & LoperamideAssay | CFDL JammuState lab | Apr 2026 |
| Loperamide Hydrochloride Tablets IP 2mg | GTE1588Mfg 2025-05 · Exp 2027-04 | Gidsha PharmaceuticalsGujarat | Misbranded-Incorrect LabellingMisbranded | DTL, PuducherryState lab | Apr 2026 |
| Loperamide Hydrochloride Capsules I.P | C-2127Mfg 2024-12 · Exp 2026-11 | Supercure Biotech Pvt. LtdHaryana | Dissolution TestDissolution | DTL, Bengaluru, KarnatakaState lab | Apr 2026 |
| Loperamide Hydrochloride Tablets IP 2 mg | T50022Mfg 2025-01 · Exp 2026-12 | Zenith Drugs Ltd. 72/5 & 72/3Madhya Pradesh | The sample does not comply as per I.P. 2022 with respect to the test for Dissolution of Loperamide Hydrochloride.Dissolution | RDTL, GuwahatiCDSCO lab | Feb 2026 |
| Loperamide Hydrochloride Tablets IP 2 MG (Lomorex Tablets) | CT-7350Mfg 2024-04 · Exp 2027-03 | Chemetac Pharmaceuticals 42 Maina PurUttar Pradesh | The sample does not comply as per I.P. 2022 with respect to the test for "Dissolution" of Loperamide Hydrochloride.Dissolution | RDTL, GuwahatiCDSCO lab | Oct 2025 |
| Loperamide HCI Tablet IP (KARLOP) | T-17075Mfg 2025-04 · Exp 2027-03 | Karnani Pharmaceuticals(P) Ltd. 38Uttarakhand | The sample does not conform to the IP with respect to AssayAssay | DTL, JaipurState lab | Oct 2025 |
| Loperamide Hydrochloride Capsules IP 2 mg | 7645Mfg 2025-03 · Exp 2027-02 | R.P. Biotech Pvt. Ltd. 61Punjab | sample does not conform to claim as per IP 2022 in respect to the Test of DissolutionDissolution | RDTL, ChandigarhCDSCO lab | Sep 2025 |
| Loperamide Hydrochloride Tablets IP (JKMSCL Hospital Supply) | T-16201Mfg 2024-05 · Exp 2026-04 | Karnani pharmaceuticals Pvt ltdUttarakhand | The sample does not conform to IP with respect to the test for Dissolution & AssayAssay | Drug Testing Laboratory Srinagar (J&K) vide report on Form 13 bearing No. L/DA/2024-25/1311 Dated: 27.09.2024. (Report attached as Annexure C)State lab | Sep 2024 |
| Loperamide Hydrochloride Tablets I.P. 2 mg (LOMJAN) | L-2401Mfg 2024-01 · Exp 2025-12 | Arya PharmaceuticalsMadhya Pradesh | Dissolution and Assay/ Content of Loperamide Hydrochloride and DescriptionAssay | RDTL GuwahatiCDSCO lab | Sep 2024 |
| Loperamide Hydrochloride Tablets IP (DYRIA STOP TABLETS) | DY?2214Mfg 2023-02 · Exp 2025-01 | Cyper PharmaHimachal Pradesh | Dissolution of Loperamide HydrochlorideDissolution | RDTL ChandigarhState lab | May 2023 |
| Lomolok (Loperamide Hydrochloride Tablets I.P.) | T8842Mfg 2021-07 · Exp 2024-06 | Quest Laboratories Pvt. LtdMadhya Pradesh | AssayAssay | RDTL GuwahatiState lab | Dec 2022 |
| Loperamide Hydrochloride Tablets IP 2 mg. (LOMOCARE) | LCT-2009Mfg 2020-09 · Exp 2022-04 | Suprex LaboratoriesMadhya Pradesh | DissolutionDissolution | RDTL GuwahatiState lab | Sep 2021 |
| SESTIL - AD (Loperamide Hydrochloride Dispersible Tablets) | CST-75Mfg 2020-07 · Exp 2023-06 | Coastal Medicare Pvt. LtdAndhra Pradesh | AssayAssay | CDL KolkataCDSCO lab | Jun 2021 |
| Loperamide Hydrochloride Tablets IP (LOPSOL TABLETS) | BT-391Mfg 2018-08 · Exp 2020-07 | Boffin Biotech Pvt. LtdHimachal Pradesh | DissolutionDissolution | RDTL ChandigarhState lab | May 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.