Ingredient record · Anti-diarrhoea medicine
Loperamide: 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 Loperamide are on India's banned-drugs list, and 3 are banned today. 21 batches of medicines containing Loperamide failed a government lab test between May 2019 and September 2026, from 18 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
Not banned Is Loperamide banned in India? Not banned · paediatric limit. Read the full status record
3
Banned combinations in force
1
Other listed orders (stayed, restricted, quashed)
21
Batches failed a lab test
Sep 2026
Latest lab alert
Is it banned? Our answer pages
Not banned · paediatric limit
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 | 16 | 13 | Sep 2026 |
| Metronidazole Furazolidone Loperamide Hcl Bolus | 1 | 1 | Sep 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 |
|---|---|---|---|---|---|
| Metronidazole, Furazolidone & Loperamide HCL Bolus (Vet) | Batch WT-002Mfg Mar 2025 · Exp Feb 2027 | Therawin FormulationsHaryana | Test for Disintegration onlyDisintegration | RDTL, Hubli, KarnatakaState lab | Sep 2026 |
| Loperamide Hydrochloride Tablets IP 2 mg- | Batch SBT-3269Mfg Jul 2025 · Exp Jun 2027 | Supercure Biotech Pvt. LtdHaryana | Sample does not conform to IP standards. This particular batch of sample fails in the tests'dissolution and assay of Loperamide Hydrochloride.Assay | RDTL , ErnakulamState lab | Sep 2026 |
| Loperamide Hydrochloride Tablets IP 2 mg | Batch LOF-26002Mfg Apr 2026 · Exp Mar 2029 | Okvik Pharma Pvt. LtdHaryana | The sample does not conform to IP in respect of Assay & DissolutionAssay | LUCKNOW, Uttar PradeshState lab | Sep 2026 |
| Loperamide Hydrochloride Tablets IP 2 mg | Batch LOP-25014Mfg Feb 2026 · Exp Jan 2029 | Okvik Pharma Pvt. LtdHaryana | The sample does not conform to I. P. in respect of Assay. (Content of Loperamide Hydrochloride)Assay | Gorakhpur, Uttar PradeshState lab | Sep 2026 |
| Loperamide Hydrochloride Tablets IP 2 mg | Batch SBT3269Mfg Jul 2025 · Exp Jun 2027 | Supercure Biotech Pvt. LtdHaryana | Dissolution and Assay of Loperamide HydrochlorideAssay | RDTL, EKMState lab | Aug 2026 |
| Loperamide Hydrochloride Tablets I.P | Batch IGT-0484Mfg Nov 2024 · Exp Oct 2027 | IG Pharma LtdUttarakhand | DescriptionDescription | RDTL, Hubli, KarnatakaState lab | Aug 2026 |
| Loperamide Hydrochloride Tablets IP 2mg | Batch 2402Mfg Mar 2025 · Exp Feb 2027 | Abil Healthcare 311Madhya Pradesh | Failed AssayAssay | DTL, PuducherryState lab | Jun 2026 |
| Ofloxacin 100mg, Ornidazole 2500mg & Loperamide 7.5mg Bolus IP | Batch DF-1677Mfg Sep 2025 · Exp Aug 2027 | Dutch Formulations 32Himachal Pradesh | Assay of Ofloxacin, Ornidazole & LoperamideAssay | CFDL JammuState lab | Apr 2026 |
| Loperamide Hydrochloride Tablets IP 2mg | Batch GTE1588Mfg May 2025 · Exp Apr 2027 | Gidsha PharmaceuticalsGujarat | Misbranded-Incorrect LabellingMisbranded | DTL, PuducherryState lab | Apr 2026 |
| Loperamide Hydrochloride Capsules I.P | Batch C-2127Mfg Dec 2024 · Exp Nov 2026 | Supercure Biotech Pvt. LtdHaryana | Dissolution TestDissolution | DTL, Bengaluru, KarnatakaState lab | Apr 2026 |
| Loperamide Hydrochloride Tablets IP 2 mg | Batch T50022Mfg Jan 2025 · Exp Dec 2026 | 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) | Batch CT-7350Mfg Apr 2024 · Exp Mar 2027 | 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) | Batch T-17075Mfg Apr 2025 · Exp Mar 2027 | 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 | Batch 7645Mfg Mar 2025 · Exp Feb 2027 | 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) | Batch T-16201Mfg May 2024 · Exp Apr 2026 | 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 |
Showing 15 of 21 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.