Product record

Loperamide Hydrochloride: batches declared Not of Standard Quality

Not bannedIs Loperamide banned in India?Not banned · paediatric limit. Read the answer

Last checked 3 November 2026. Source: CDSCO monthly NSQ alerts, Jan 2019 to Sep 2026

16 batches of products named "Loperamide Hydrochloride" (as printed by the testing lab) failed a CDSCO or state drug-testing laboratory test between May 2019 and September 2026. This is a record of specific batches, it does not mean the molecule or every brand is unsafe.

Records by type

16 records linked to Loperamide Hydrochloride in the datasets we hold. A zero means nothing is on record in those datasets, not that nothing ever happened. What the labels mean.

0Banned or prohibited
0Recalled or suspended
16Failed a lab test
0Regulatory notice
Primary government sourceTier 1: government primary source

CDSCO drug alerts: Not of Standard Quality and spurious drugs

CDSCO · CDSCO monthly NSQ alerts, May 2019 to Sep 2026

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Scope. A failed batch is not a verdict on every pack of this product. Regulatory actions can apply to one batch, one formulation, one period or one state. Always check the linked government document for the current position, and tell us if something is out of date. How we label records.

16
NSQ batches
13
Manufacturers
Dissolution
Most common reason
Sep 2026
Latest alert

Flagged batches

Batch Manufacturer Reason declared NSQ Tested by Alert
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
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
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
Batch SBT3269Mfg Jul 2025 · Exp Jun 2027 Supercure Biotech Pvt. LtdHaryana Dissolution and Assay of Loperamide HydrochlorideAssay RDTL, EKMState lab Aug 2026
Batch IGT-0484Mfg Nov 2024 · Exp Oct 2027 IG Pharma LtdUttarakhand DescriptionDescription RDTL, Hubli, KarnatakaState lab Aug 2026
Batch 2402Mfg Mar 2025 · Exp Feb 2027 Abil Healthcare 311Madhya Pradesh Failed AssayAssay DTL, PuducherryState lab Jun 2026
Batch GTE1588Mfg May 2025 · Exp Apr 2027 Gidsha PharmaceuticalsGujarat Misbranded-Incorrect LabellingMisbranded DTL, PuducherryState lab Apr 2026
Batch C-2127Mfg Dec 2024 · Exp Nov 2026 Supercure Biotech Pvt. LtdHaryana Dissolution TestDissolution DTL, Bengaluru, KarnatakaState lab Apr 2026
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
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
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
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
Batch L-2401Mfg Jan 2024 · Exp Dec 2025 Arya PharmaceuticalsMadhya Pradesh Dissolution and Assay/ Content of Loperamide Hydrochloride and DescriptionAssay RDTL GuwahatiCDSCO lab Sep 2024
Batch DY?2214Mfg Feb 2023 · Exp Jan 2025 Cyper PharmaHimachal Pradesh Dissolution of Loperamide HydrochlorideDissolution RDTL ChandigarhState lab May 2023
Batch LCT-2009Mfg Sep 2020 · Exp Apr 2022 Suprex LaboratoriesMadhya Pradesh DissolutionDissolution RDTL GuwahatiState lab Sep 2021
Batch BT-391Mfg Aug 2018 · Exp Jul 2020 Boffin Biotech Pvt. LtdHimachal Pradesh DissolutionDissolution RDTL ChandigarhState lab May 2019

How to use this. Match the batch number on your strip or bottle against the list. If your batch is listed, return it to the pharmacy and ask for a replacement; if not, the product is not on any alert as of September 2026. Check any batch number.