Product record

Paracetamol Paediatric: batches declared Not of Standard Quality

Last checked 20 September 2026. Source: CDSCO monthly NSQ alerts, Jan 2019, Jul 2026

16 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 July 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 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
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, Mar 2020 to Jul 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 Always check the linked government document for the current position, and tell us if something is out of date.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.

16
NSQ batches
13
Manufacturers
Assay
Most common reason
Jul 2026
Latest alert

Flagged batches

Batch Manufacturer Reason declared NSQ Tested by Alert
PCS25194Mfg 2025-09 · Exp 2027-08 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
L5DD15Mfg 2025-01 · Exp 2026-12 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
LB5172Mfg 2025-10 · Exp 2027-09 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
SL25156Mfg 2026-03 · Exp 2028-02 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
L5G174Mfg 2025-07 · Exp 2027-06 Smayan Healthcare Pvt. Ltd. Plot No. 8- 9-26-27Himachal Pradesh Test For Assay (Content) Of ParacetamolAssay DelhiState lab Jun 2026
L5G175Mfg 2025-07 · Exp 2027-06 Smayan Healthcare Pvt. Ltd. Plot No. 8- 9-26-27Himachal Pradesh Test For Assay (Content) Of ParacetamolAssay DelhiState lab Jun 2026
SAI-1808Mfg 2025-07 · Exp 2027-06 Sree Saie PharmaTamil Nadu ContentOther DTL, Chennai-06State lab Feb 2026
SP-684Mfg 2024-11 · Exp 2026-11 South East pharmaceuticalsTamil Nadu Impurity (EG) Limit:Not More than 0.1%, Present-0.385%Other Drugs Testing Laboratory, Chennai-06State lab Nov 2025
SP-683Mfg 2024-11 · Exp 2026-11 South East pharmaceuticalsTamil Nadu Impurity (EG) Limit:Not More than 0.1%, Present-0.4%Other Drugs Testing Laboratory, Chennai-06State lab Nov 2025
CL-24098Mfg 2025-02 · Exp 2027-01 Casid Pharmaceuticals Pvt.LtdTamil Nadu Failed in AssayAssay DTL, PuducherryState lab Oct 2025
KGP. 240227.Mfg 2024-02 · Exp 2026-01 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
S404115Mfg 2024-04 · Exp 2026-03 ION Healthcare Pvt. LtdHimachal Pradesh "Related substances"Related substances CDTL MumbaiCDSCO lab Dec 2024
V0244001Mfg 2024-02 · Exp 2026-01 Vivimed Labs LimitedUttarakhand Related SubstancesRelated substances CDTL MumbaiCDSCO lab Sep 2024
PFSC081019Mfg 2019-10 · Exp 2022-09 Strassenburg Pharmaceuticals LtdWest Bengal AssayAssay RDTL GuwahatiState lab Jun 2022
PWS-1905Mfg 2019-12 · Exp 2021-11 Apple Formulations Pvt. LtdUttarakhand Related SubstancesRelated substances RDTL ChandigarhCDSCO lab Nov 2020
RV19007Mfg 2019-11 · Exp 2021-10 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 July 2026. Check any batch number.