Product record

Paracetamol Paediatric: batches declared Not of Standard Quality

Not bannedIs Paracetamol (Dolo 650) banned in India?Not banned. Read the answer

Not bannedIs Paracetamol (Calpol) banned in India?Not banned. Read the answer

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

20 batches of products named "Paracetamol Paediatric" (as printed by the testing lab) failed a CDSCO or state drug-testing laboratory test between March 2020 and September 2026. This is a record of specific batches, it does not mean the molecule or every brand is unsafe.

Records by type

20 records linked to Paracetamol Paediatric 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
20Failed 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, Mar 2020 to Sep 2026

View original document

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 Always check the linked government document for the current position, and tell us if something is out of date.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.

20
NSQ batches
16
Manufacturers
Assay
Most common reason
Sep 2026
Latest alert

Flagged batches

Batch Manufacturer Reason declared NSQ Tested by Alert
Batch PAMLA002Mfg Aug 2025 · Exp Jul 2027 Laborate Pharmaceuticals India LtdHimachal Pradesh The sample does not conform to IP in respect of content of Paracetamol.Other LUCKNOW, Uttar PradeshState lab Sep 2026
Batch PAD1130Mfg Feb 2026 · Exp Jan 2028 REVIVE Formulations India Pvt. LtdTamil Nadu Misbranded-Incorrect LabellingMisbranded DTL, PuducherryState lab Sep 2026
Batch PCS25194Mfg Sep 2025 · Exp Aug 2027 Vivek Pharmachem (India) LtdRajasthan The sample does not conform to IP standards. It fails the test Microbial Examination of Non- Sterile Product as per IP, as specified in the Laboratory protocol.Microbial limits DTL, TVPMState lab Jul 2026
Batch L5DD15Mfg Jan 2025 · Exp Dec 2026 Zenith Drugs Ltd. 72/5 & 72/3Madhya Pradesh The sample does not comply with IP requirement for related substances test. The sample does notshow identification test for colour carmoisine, Hence the sample is misbranded vide rule 96 and section 17(b) and 17 (c) of Drugs and Cosmetics Act 1940 and Rules thereunderIdentification FDAL, MumbaiState lab Jun 2026
Batch LB5172Mfg Oct 2025 · Exp Sep 2027 Zenith Drugs Ltd. 72/5 & 72/3Madhya Pradesh The sample does not comply with IP requirement for related substances.Related substances FDAL, MumbaiState lab Jun 2026
Batch SL25156Mfg Mar 2026 · Exp Feb 2028 Skylink PharmaGujarat The sample does not conform to as per I.P. 2022 with respect to the test of Microbial contamination (Total aerobic viable count).Microbial limits CDTL, MumbaiCDSCO lab Jun 2026
Batch L5G174Mfg Jul 2025 · Exp Jun 2027 Smayan Healthcare Pvt. LtdHimachal Pradesh Test For Assay (Content) Of ParacetamolAssay DelhiState lab Jun 2026
Batch L5G175Mfg Jul 2025 · Exp Jun 2027 Smayan Healthcare Pvt. LtdHimachal Pradesh Test For Assay (Content) Of ParacetamolAssay DelhiState lab Jun 2026
Batch SAI-1808Mfg Jul 2025 · Exp Jun 2027 Sree Saie PharmaTamil Nadu ContentOther DTL, Chennai-06State lab Feb 2026
Batch SP-684Mfg Nov 2024 · Exp Nov 2026 South East pharmaceuticalsTamil Nadu Impurity (EG) Limit:Not More than 0.1%, Present-0.385%Other Drugs Testing Laboratory, Chennai-06State lab Nov 2025
Batch SP-683Mfg Nov 2024 · Exp Nov 2026 South East pharmaceuticalsTamil Nadu Impurity (EG) Limit:Not More than 0.1%, Present-0.4%Other Drugs Testing Laboratory, Chennai-06State lab Nov 2025
Batch CL-24098Mfg Feb 2025 · Exp Jan 2027 Casid Pharmaceuticals Private LimitedTamil Nadu Failed in AssayAssay DTL, PuducherryState lab Oct 2025
Batch KGP. 240227.Mfg Feb 2024 · Exp Jan 2026 Mfg By: Karuppharma Pvt.LtdTelangana MISBRANDED The label of the sample indicates only Approved Coloures Used but failed to indicate the common name of the color, as required as per Rule 127(2) of the Drugs Rules, 1945. Hence the drug is deemed to be Misbranded as per Section 17 of the Drugs and Cosmetics Act, 1940, as the drug is not labeled in the prescribed manner.Misbranded State Lab, Drugs Control Laboratory, TelanganaState lab Mar 2025
Batch S404115Mfg Apr 2024 · Exp Mar 2026 ION Healthcare Pvt. LtdHimachal Pradesh "Related substances"Related substances CDTL MumbaiCDSCO lab Dec 2024
Batch V0244001Mfg Feb 2024 · Exp Jan 2026 Vivimed Labs LimitedUttarakhand Related SubstancesRelated substances CDTL MumbaiCDSCO lab Sep 2024
Batch D10086Mfg Oct 2021 · Exp Sep 2024 Dm Pharma Private LimitedHimachal Pradesh Related Substances and Assay of ParacetamolAssay RDTL ChandigarhCDSCO lab Dec 2022
Batch D10085Mfg Oct 2021 · Exp Sep 2024 Dm Pharma Private LimitedHimachal Pradesh Related Substances and Assay of ParacetamolAssay RDTL ChandigarhCDSCO lab Dec 2022
Batch PFSC081019Mfg Oct 2019 · Exp Sep 2022 Strassenburg Pharmaceuticals LtdWest Bengal AssayAssay RDTL GuwahatiState lab Jun 2022
Batch PWS-1905Mfg Dec 2019 · Exp Nov 2021 Apple Formulations Pvt. LtdUttarakhand Related SubstancesRelated substances RDTL ChandigarhCDSCO lab Nov 2020
Batch RV19007Mfg Nov 2019 · Exp Oct 2021 Rivpra Formulations Pvt. LtdUttarakhand AssayAssay RDTL ChandigarhState lab Mar 2020

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.