Manufacturer record

Sigma Softgel & Formulation: regulatory record

Last checked 3 November 2026. Source: CDSCO monthly NSQ alerts and state drug-testing laboratories

8 batches manufactured by Sigma Softgel & Formulation (Himachal Pradesh) were declared Not of Standard Quality between March 2024 and June 2026. Records are batch-specific findings by government laboratories as published in CDSCO's monthly alerts; where a company has stated that a flagged batch was counterfeit, that statement is noted when reported.

Most recent flagged batch: D251058A, Ferrous Asparto Glycinate L- Methylfolate Calcium & Methylcobalamin Soft Gelatin Capsules (exp Mar 2027). RDTL, Ernakulam (state lab) found it not of standard quality: Sample does not confrom to Schedule V of the Drug Rule 1945 with respect to the disintegration and assay of L-Methylfolate Calcium as. Listed in the June 2026 alert.

Records by type

8 records linked to Sigma Softgel & Formulation 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
8Failed 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 2024 to Jun 2026

View original document

Scope. A company appearing here is not a finding that its products are unsafe. 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 Always check the linked government document for the current position, and tell us if something is out of date.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.

8
NSQ batches since 2024
8
Products affected
Assay
Most common failure
Jun 2026
Latest alert

Flagged batches per year

2024 · 22025 · 42026 · 2

All flagged batches

Product Batch Reason declared NSQ Tested by Alert
Ferrous Asparto Glycinate L- Methylfolate Calcium & Methylcobalamin Soft Gelatin Capsules Batch D251058AMfg Apr 2025 · Exp Mar 2027 Sample does not confrom to Schedule V of the Drug Rule 1945 with respect to the disintegration and assay of L-Methylfolate Calcium as specified in the laboratory protocol.Assay RDTL, ErnakulamState lab Jun 2026
Calcium, Calcitriol & Vitamin K27 Softgel Capsules Batch D251340CMfg Jun 2025 · Exp May 2027 Test for DisintegrationDisintegration RDTL, Bellary, KarnatakaState lab Jan 2026
Calcitriol, Calcium Carbonate, Zinc Oxide, Magnesium Oxide, Vitamin K27, Methylcobalamin & L-Methylfolate Soft Gelatin Capsules Batch D242039GMfg Aug 2024 · Exp Jul 2026 Test for Disintegration onlyDisintegration RDTL, Hubli, KarnatakaState lab Nov 2025
Omega-3 Fatty Acid, Methylcobalamin, Calcitriol, Folic Acid, Boron & Calcium Carbonate Soft Gel Capsules Batch D241600AMfg Jun 2024 · Exp May 2026 Assay of MethylcobalaminAssay CDL, KolkataCDSCO lab Aug 2025
Zeora DSR (Rabeprazole and Domperidone Capsule) Batch SD6732FMfg Sep 2023 · Exp Aug 2025 The sample does not conform to claim with respect of 'Assay' test.Assay State Drugs Testing Laboratory, Kolkata, West BengalState lab Jul 2025
ITRADEL-200k Batch SD6005CMfg Jun 2023 · Exp May 2025 The sample does not comply with IP requirements for Dissolution testDissolution CDTL MumbaiCDSCO lab Apr 2025
Pantoprazole Tablets IP 40 mg (Mb2pan 40 Tablets) Batch SD6686AMfg Aug 2023 · Exp Jul 2025 Dissolution (Buffer Stage)Dissolution RDTL ChandigarhCDSCO lab Nov 2024
Aceclofenac, Paracetamol & Serratiopeptidase Tablets (ACEMETIL-SP Tablets) Batch SD7744AMfg Dec 2023 · Exp Nov 2025 DescriptionDescription CDL KolkataCDSCO lab Mar 2024

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