Manufacturer record

Apple Formulations Pvt. Ltd: regulatory record

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

49 batches manufactured by Apple Formulations Pvt. Ltd (Uttarakhand) were declared Not of Standard Quality between April 2020 and July 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: OXG2501, Ofloxacin Metronidazole and Simethicone Suspension (exp Aug 2027). Drugs Testing Laboratory, Madurai-19 (state lab) found it not of standard quality: Content of Metronidazole (45.68%). Listed in the July 2026 alert.

Records by type

49 records linked to Apple Formulations Pvt. Ltd 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
49Failed 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, Apr 2020 to Jul 2026

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 Always check the linked government document for the current position, and tell us if something is out of date.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

49
NSQ batches since 2020
26
Products affected
pH
Most common failure
Jul 2026
Latest alert

Flagged batches per year

2020 · 32022 · 92023 · 112024 · 22025 · 172026 · 7

All flagged batches

Product Batch Reason declared NSQ Tested by Alert
Ofloxacin Metronidazole and Simethicone Suspension Batch OXG2501Mfg Sep 2025 · Exp Aug 2027 Content of Metronidazole (45.68%)Other Drugs Testing Laboratory, Madurai-19State lab Jul 2026
Glimepiride Tablets IP 1mg Batch GTA-2501Mfg Jan 2025 · Exp Jan 2027 The sample does not conform to standard quality in respect of the test for ?Description? performed.Description SDTL, Tripura, AgartalaState lab Jul 2026
Sucralfate & Oxetacaine Suspension Batch SCI-2508Mfg Dec 2025 · Exp Nov 2027 ContentOther DTL, Madurai-19State lab Jun 2026
Cetirizine Syrup IP Batch CIZ-2604Mfg Mar 2026 · Exp Feb 2028 pHpH SDTL, PunjabState lab Jun 2026
Levocetrizine Dihydrochloride Tablets IP) Batch LEE-2501Mfg Jun 2025 · Exp May 2027 The sample does not conform to standard in respect of the test for Description performed.Description SDTL,Govt. of Tripura, AgartalaState lab May 2026
Amlodipine Besylate Tablets IP Batch AML-2506Mfg Dec 2025 · Exp Nov 2027 The sample received does not conform to I.P. 2022 with respect to the test for Related substances. other test could not be done due to technical reason.Related substances CDTL, MumbaiCDSCO lab May 2026
Ondansetron Orally Disintegrating Tablets IP 4 mg Batch OSD-2501Mfg Nov 2025 · Exp Oct 2027 The sample does not conform to I.P.w.r.t. the tests for AssayAssay SDTL, AssamState lab Mar 2026
Levosalbutamol, Ambroxol Hydrochloride & Guaiphenesin Syrup (Ambroflex-LS Syrup) Batch AFG-2502Mfg May 2025 · Exp Apr 2027 ContentOther Drugs Testing Laboratory, Chennai-06State lab Dec 2025
Dextromethorphan Hydrobromide, Chlorpheniramine Maleate, Phenylephrine Hydrochloride Syrup(Caredex Junior) Batch CXR-2502Mfg Jun 2025 · Exp May 2027 ContentOther Drugs Testing Laboratory, Madurai-19State lab Dec 2025
Ambroxol Hydrochloride. Levosalbutamol Sulphate and Guaiphenesin syrup (Brokuff LS Junior Syrup) Batch BKJ-2503Mfg Apr 2025 · Exp Mar 2027 ContentOther Drugs Testing Laboratory, Madurai-19State lab Dec 2025
Albendazole Tablets IP 400 mg Batch AAO-2502Mfg Apr 2025 · Exp Mar 2027 Assay (Albendazole)Assay SDTL, GuwahatiState lab Dec 2025
Sucralfate & Oxetacaine Suspension Batch SCO-2503Mfg Jun 2025 · Exp May 2027 ContentOther Drugs Testing Laboratory, Chennai-06State lab Nov 2025
Azithromycin Tablets IP 500 mg. Batch AYC-2407Mfg Jan 2024 · Exp Dec 2025 The sample does not comply as per I.P. 2022 with respect to the test for "Dissolution" of Azithromycin.Dissolution RDTL, GuwahatiCDSCO lab Nov 2025
Ambroxol Hydrochloride 15mg, Terbutaline Sulphate 1.25 mg, Guaiphenesin 50 mg, Menthol 0.5 mg (NUREX-AP) Batch NRA-2403Mfg Dec 2024 · Exp Nov 2026 Assay of Ambroxol HCl (81.53%) & Terbutaline Sulphate (74.40 %)Assay DTL Baddi H.PState lab Oct 2025
Ofloxacin & Ornidazole Tablets I.P.. Batch OZH-2501Mfg Apr 2025 · Exp Mar 2027 sample does not comply as per I.P. 2022 with respect to the test for "Dissolution" of Ofloxacin and Ornidazole.Dissolution RDTL, GuwahatiCDSCO lab Sep 2025
Miconazole Nitrate Cream IP 2% w/w Batch MZP-2502Mfg Aug 2025 · Exp Jul 2027 AssayAssay SDTL, PunjabState lab Sep 2025
Cholecalciferol (Vitamin D3) Oral Solution USP 400 IU/ml Batch VAM-2501Mfg Jun 2025 · Exp Nov 2026 The Product is not labeled in the prescribed manner as per USP monographLabelling State Drugs Laboratory, PunjabState lab Aug 2025
Azithromycin Tablets IP 500 mg. Batch AYC-2407Mfg Jan 2024 · Exp Dec 2025 Dissolution of AzithromycinDissolution RDTL GuwahatiCDSCO lab Jun 2025
Vitamin B1, Vitamin B2, Nicotinamide, Vitamin B6, Vitamin B12 & Calcium D-Pantothenate Syrup (B-Complex Syrup) Batch BOB-2440Mfg Jun 2024 · Exp Nov 2025 Assay of Vitamin B12Assay CDL, KolkataCDSCO lab Mar 2025
Vitamin B1, Vitamin B2, Nicotinamide, Vitamin B6, Vitamin B12 & Calcium D-Pantothenate Syrup (B-Complex Syrup) Batch BOB-2451Mfg Jun 2024 · Exp Nov 2025 Total aerobic viable count under Microbial limit testMicrobial limits CDL, KolkataCDSCO lab Mar 2025
Vitamin B1, Vitamin B2, Nicotinamide, Vitamin B6, Vitamin B12 & Calcium D- Pantothenate Syrup (B- Complex Syrup) Batch BOB-2424Mfg Jun 2024 · Exp Nov 2025 Assay of Calcium D-PantothenateAssay CDL KolkataCDSCO lab Feb 2025
Vitamin B1, Vitamin B2, Nicotinamide, Vitamin B6, Vitamin B12 & Calcium D- Pantothenate Syrup (B- Complex Syrup), Batch BOB-2423Mfg Jun 2024 · Exp Nov 2025 Assay of Calcium D-PantothenateAssay CDL KolkataCDSCO lab Feb 2025
Vitamin B1, Vitamin B2, Nicotinamide, Vitamin B6, Vitamin B12 & Calcium D- Pantothenate Syrup (B- Complex Syrup) Batch BOB-2438Mfg Jun 2024 · Exp Nov 2025 Assay of Vitamin B12Assay CDL KolkataCDSCO lab Feb 2025
Sucnol-O Suspension Batch SCI-2305Mfg Nov 2023 · Exp Oct 2025 Sample does not conform to Label Claim with respect to the content of OxetacaineLabelling DTL MaduraiState lab Jan 2025
Etoricoxib Tablets I.P. 90 mg. Batch ECX-2304Mfg Aug 2023 · Exp Jul 2025 DissolutionDissolution RDTL GuwahatiCDSCO lab Jun 2024
GLIMEPIRIDE TABLETS I.P. 1 mg. Batch GLT-2301Mfg Jan 2023 · Exp Dec 2024 DissolutionDissolution RDTL GuwahatiState lab Jan 2024
GLIMEPIRIDE TABLETS I.P. 1 mg. Batch GLT-2301Mfg Jan 2023 · Exp Dec 2024 DissolutionDissolution RDTL GuwahatiState lab Nov 2023
Rabeprazole Sodium (Enteric Coated) and Domperidone (Sustained Release) Capsules (20 mg/30 mg) Batch RPE-2258Mfg Jul 2022 · Exp Jun 2024 Assay of Rabeprazole SodiumAssay RDTL ChandigarhCDSCO lab Jul 2023
Glimkar-4 (Glimepiride Tablets 4 mg) Batch GKR-2210Mfg Apr 2022 · Exp Mar 2024 DissolutionDissolution CDL KolkataCDSCO lab Jun 2023
Levocetirizine Dihydrochloride Syrup., 30ml Batch LZR-2202Mfg Jan 2022 · Exp Dec 2023 pHpH RDTL GuwahatiState lab Feb 2023
Levocetirizine Dihydrochloride Syrup., 30ml Batch LZR-2204Mfg Jan 2022 · Exp Dec 2023 pHpH RDTL GuwahatiState lab Feb 2023
Levocetirizine Dihydrochloride Syrup Batch LZR-2203Mfg Jan 2022 · Exp Dec 2023 pHpH RDTL GuwahatiState lab Feb 2023
Zinc Sulphate Oral Solution I.P., 100ml Batch ZCH-2207Mfg Jan 2022 · Exp Dec 2023 Weight per mlWeight RDTL GuwahatiState lab Jan 2023
Zinc Sulphate Oral Solution I.P., 100 ml Batch ZCH-2209Mfg Jan 2022 · Exp Dec 2023 Weight per mlWeight RDTL GuwahatiState lab Jan 2023
Levocetirizine Dihydrochloride Syrup 30 ml Batch LZR-2209Mfg Jan 2022 · Exp Dec 2023 pHpH RDTL GuwahatiState lab Jan 2023
Levocetirizine Dihydrochloride Syrup 30 ml Batch LZR-2207Mfg Jan 2022 · Exp Dec 2023 pHpH RDTL GuwahatiState lab Jan 2023
Levocetirizine Dihydrochloride Syrup 30 ml Batch LZR-2211Mfg Jan 2022 · Exp Dec 2023 pHpH RDTL GuwahatiState lab Jan 2023
Levocetirizine Dihydrochloride Syrup, 30ml Batch LZR-2204Mfg Jan 2022 · Exp Dec 2023 pHpH RDTL GuwahatiState lab Dec 2022
Levocetirizine Dihydrochloride Syrup Batch LZR-2204Mfg Jan 2022 · Exp Dec 2023 pHpH RDTL GuwahatiState lab Dec 2022
Levocetirizine Dihydrochloride Syrup Batch LZR-2208Mfg Jan 2022 · Exp Dec 2023 ?pH?pH RDTL GuwahatiState lab Dec 2022
Levocetirizine Dihydrochloride Syrup. 30 ml Batch LZR-2202Mfg Jan 2022 · Exp Dec 2023 ?pH?pH RDTL GuwahatiState lab Nov 2022
Levocetirizine Dihydrochloride Syrup (30 ml) Batch LZR-2207Mfg Jan 2022 · Exp Dec 2023 ?pH?pH RDTL GuwahatiState lab Nov 2022
Levocetirizine Dihydrochloride Syrup Batch LZR-2204Mfg Jan 2022 · Exp Dec 2023 ?pH?pH RDTL GuwahatiState lab Nov 2022
Levocetirizine Dihydrochloride Syrup Batch LZR-2202Mfg Jan 2022 · Exp Dec 2023 pHpH RDTL GuwahatiState lab Sep 2022
Azithromycin Oral Suspension IP 200 mg/ 5 ml Batch AYA-2101Mfg Jan 2021 · Exp Dec 2022 Assay/content of Anhydrous AzithromycinAssay RDTL GuwahatiState lab Sep 2022
Levocetirizine Dihydrochloride Tablets IP 5 mg Batch LCL-2105Mfg Jul 2021 · Exp Jun 2023 DissolutionDissolution RDTL GuwahatiState lab Jul 2022
Paracetamol Paediatric oral Suspension IP (Parawin ?DS Suspension) Batch PWS-1905Mfg Dec 2019 · Exp Nov 2021 Related SubstancesRelated substances RDTL ChandigarhCDSCO lab Nov 2020
Alumina, Magnesia & Simethicone Oral Suspension IP Batch AME-1901Mfg Apr 2019 · Exp Mar 2021 Assay of DimethiconeAssay CDTL MumbaiCDSCO lab Apr 2020
Alumina, Magnesia & Simethicone Oral Suspension IP Batch AME-1902Mfg Apr 2019 · Exp Mar 2021 Assay of DimethiconeAssay CDTL MumbaiCDSCO lab Apr 2020

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