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Caffeine: bans, restrictions and failed batches in India

Last checked 20 September 2026. Sources: CDSCO banned-drugs notifications and monthly NSQ alerts, Jan 2019 to Jul 2026

59 entries containing Caffeine are on India's banned-drugs list, and 32 are banned today. 17 batches of medicines containing Caffeine failed a government lab test between March 2020 and May 2026, from 15 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.

32
Banned combinations in force
27
Other listed orders (stayed, restricted, quashed)
17
Batches failed a lab test
May 2026
Latest lab alert

Is it banned? Our answer pages

On sale · pre-1988 FDC under review
SC interim relief · on sale
On sale · pre-1988 FDC under review

On the banned-drugs list

Caffeine on its own is not on CDSCO's banned list. The entries below are specific combinations that contain it. Status follows CDSCO's own notes on each entry.

Drug / combinationActionNotificationDateOrderStatus note
Ergotamine Tartrate + Caffeine + Paracetamol + Prochlorperazine MaleateFixed-dose combination · painkillers Banned S.O. 3347(E) 2 August 2024 156 FDCs · Aug 2024 Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024.
Meclizine HCl + Paracetamol + CaffeineFixed-dose combination · painkillers Banned S.O. 3352(E) 2 August 2024 156 FDCs · Aug 2024 Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024.
Paracetamol + Diclofenac Potassium + Caffeine AnhydrousFixed-dose combination · painkillers Banned S.O. 3417(E) 2 August 2024 156 FDCs · Aug 2024 Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024.
Tramadol HCl + Paracetamol + Caffeine + TaurineFixed-dose combination · painkillers Banned S.O. 3440(E) 2 August 2024 156 FDCs · Aug 2024 Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024.
Atorvastatin + Acetyl Salicylic Acid + CaffeineFixed-dose combination · painkillers Banned S.O. 184(E) 11 January 2019 Other orders One of 80 FDCs prohibited vide S.O. 180(E)-259(E) dated 11.01.2019 (CDSCO letter 22.01.2019). In force per CDSCO list as on 22.11.2021.
Nimesulide + Phenylephrine + Chlorpheniramine Maleate + CaffeineFixed-dose combination · cough-cold Banned S.O. 254(E) 11 January 2019 Other orders One of 80 FDCs prohibited vide S.O. 180(E)-259(E) dated 11.01.2019 (CDSCO letter 22.01.2019). In force per CDSCO list as on 22.11.2021.
Paracetamol + Propyphenazone + CaffeineFixed-dose combination · painkillers Under examination S.O. 4689(E) 7 September 2018 328 FDCs · Sep 2018 SC order 14.02.2019: claimed pre-1988 FDC; under examination with Expert Committee per CDSCO list as on 22.11.2021 (note 4#). Legally on sale pending examination.
Nimesulide + Cetirizine + CaffeineFixed-dose combination · painkillers Banned S.O. 4381(E) 7 September 2018 328 FDCs · Sep 2018 In force per CDSCO list as on 22.11.2021
Paracetamol + Cetirizine + CaffeineFixed-dose combination · painkillers Banned S.O. 4383(E) 7 September 2018 328 FDCs · Sep 2018 In force per CDSCO list as on 22.11.2021
Paracetamol + Phenylephrine + Chlorpheniramine + Dextromethorphan + CaffeineFixed-dose combination · cough-cold Banned S.O. 4395(E) 7 September 2018 328 FDCs · Sep 2018 In force per CDSCO list as on 22.11.2021
Paracetamol + Domperidone + CaffeineFixed-dose combination · painkillers Banned S.O. 4410(E) 7 September 2018 328 FDCs · Sep 2018 In force per CDSCO list as on 22.11.2021
Paracetamol + Disodium Hydrogen Citrate + CaffeineFixed-dose combination · painkillers Banned S.O. 4416(E) 7 September 2018 328 FDCs · Sep 2018 In force per CDSCO list as on 22.11.2021
Paracetamol + Caffeine + Codeine PhosphateFixed-dose combination · painkillers Banned S.O. 4419(E) 7 September 2018 328 FDCs · Sep 2018 In force per CDSCO list as on 22.11.2021
Paracetamol + Loratadine + Phenylephrine + Dextromethorphan + CaffeineFixed-dose combination · cough-cold Banned S.O. 4526(E) 7 September 2018 328 FDCs · Sep 2018 In force per CDSCO list as on 22.11.2021
Nimesulide + Phenylephrine + Caffeine + LevocetirizineFixed-dose combination · cough-cold Banned S.O. 4527(E) 7 September 2018 328 FDCs · Sep 2018 In force per CDSCO list as on 22.11.2021
Paracetamol + Loratadine + Dextromethorphan + Pseudoepheridine + CaffeineFixed-dose combination · cough-cold Banned S.O. 4531(E) 7 September 2018 328 FDCs · Sep 2018 In force per CDSCO list as on 22.11.2021
Chlorpheniramine + Phenylephrine + CaffeineFixed-dose combination · cough-cold Banned S.O. 4539(E) 7 September 2018 328 FDCs · Sep 2018 In force per CDSCO list as on 22.11.2021
Acrivastine + Paracetamol + Caffeine + PhenylephrineFixed-dose combination · cough-cold Banned S.O. 4576(E) 7 September 2018 328 FDCs · Sep 2018 In force per CDSCO list as on 22.11.2021
Nimesulide + Paracetamol + Levocetirizine + Phenylephrine + CaffeineFixed-dose combination · cough-cold Banned S.O. 4579(E) 7 September 2018 328 FDCs · Sep 2018 In force per CDSCO list as on 22.11.2021
Dextromethorphan + Phenylephrine + Cetirizine + Paracetamol + CaffeineFixed-dose combination · cough-cold Banned S.O. 4588(E) 7 September 2018 328 FDCs · Sep 2018 In force per CDSCO list as on 22.11.2021
Paracetamol + Phenylephrine + Levocetirizine + CaffeineFixed-dose combination · cough-cold Banned S.O. 4590(E) 7 September 2018 328 FDCs · Sep 2018 In force per CDSCO list as on 22.11.2021
Cetirizine + Phenylephrine + Paracetamol + Ambroxol + CaffeineFixed-dose combination · cough-cold Banned S.O. 4605(E) 7 September 2018 328 FDCs · Sep 2018 In force per CDSCO list as on 22.11.2021
Levocetirizine + Paracetamol + Phenylephrine + CaffeineFixed-dose combination · cough-cold Banned S.O. 4607(E) 7 September 2018 328 FDCs · Sep 2018 In force per CDSCO list as on 22.11.2021
Paracetamol + Phenylephrine + Triprolidine + CaffeineFixed-dose combination · cough-cold Banned S.O. 4610(E) 7 September 2018 328 FDCs · Sep 2018 In force per CDSCO list as on 22.11.2021
Caffeine + Paracetamol + Phenylephrine + CetirizineFixed-dose combination · cough-cold Banned S.O. 4611(E) 7 September 2018 328 FDCs · Sep 2018 In force per CDSCO list as on 22.11.2021
Caffeine + Paracetamol + ChlorpheniramineFixed-dose combination · cough-cold Banned S.O. 4620(E) 7 September 2018 328 FDCs · Sep 2018 In force per CDSCO list as on 22.11.2021
Paracetamol + Pseudoephedrine + Cetirizine + CaffeineFixed-dose combination · cough-cold Banned S.O. 4626(E) 7 September 2018 328 FDCs · Sep 2018 In force per CDSCO list as on 22.11.2021
Cetirizine + Phenylephrine + Paracetamol + Caffeine + NimesulideFixed-dose combination · painkillers Banned S.O. 4639(E) 7 September 2018 328 FDCs · Sep 2018 In force per CDSCO list as on 22.11.2021
Chlorpheniramine + Paracetamol + Pseudoephedrine + CaffeineFixed-dose combination · cough-cold Banned S.O. 4653(E) 7 September 2018 328 FDCs · Sep 2018 In force per CDSCO list as on 22.11.2021
Ergotamine Tartrate + Belladonna Dry Extract + Caffeine + ParacetamolFixed-dose combination · painkillers Banned S.O. 4681(E) 7 September 2018 328 FDCs · Sep 2018 In force per CDSCO list as on 22.11.2021
Phenylephrine + Chlorpheniramine + Paracetamol + Bromhexine + CaffeineFixed-dose combination · cough-cold Banned S.O. 4700(E) 7 September 2018 328 FDCs · Sep 2018 In force per CDSCO list as on 22.11.2021
Nimesulide + Cetirizine + CaffeineFixed-dose combination · painkillers Quashed S.O. 707(E) 10 March 2016 344 FDCs · Mar 2016 Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban
Paracetamol + Cetirizine + CaffeineFixed-dose combination · painkillers Quashed S.O. 709(E) 10 March 2016 344 FDCs · Mar 2016 Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban
Paracetamol + Phenylephrine + CaffeineFixed-dose combination · painkillers Under examination S.O. 713(E) 10 March 2016 344 FDCs · Mar 2016 Quashed by Delhi HC 1 Dec 2016; SC order 15.12.2017 treated it as a pre-1988 FDC, under examination with Expert Committee per CDSCO list as on 22.11.2021 (note 3#). 14 of these 15 were re-prohibited on 02.06.2023 (wave 2023-14).
Paracetamol + Phenylephrine + Chlorpheniramine + Dextromethorphan + CaffeineFixed-dose combination · cough-cold Quashed S.O. 723(E) 10 March 2016 344 FDCs · Mar 2016 Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban
Paracetamol + Domperidone + CaffeineFixed-dose combination · painkillers Quashed S.O. 739(E) 10 March 2016 344 FDCs · Mar 2016 Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban
Paracetamol + Disodium Hydrogen Citrate + CaffeineFixed-dose combination · painkillers Quashed S.O. 746(E) 10 March 2016 344 FDCs · Mar 2016 Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban
Paracetamol + Caffeine + Codeine PhosphateFixed-dose combination · painkillers Quashed S.O. 749(E) 10 March 2016 344 FDCs · Mar 2016 Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban
Paracetamol + Loratadine + Phenylephrine + Dextromethorphan + CaffeineFixed-dose combination · cough-cold Quashed S.O. 863(E) 10 March 2016 344 FDCs · Mar 2016 Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban
Paracetamol + Loratadine + Dextromethorphan + Pseudoepheridine + CaffeineFixed-dose combination · cough-cold Quashed S.O. 868(E) 10 March 2016 344 FDCs · Mar 2016 Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban
Acrivastine + Paracetamol + Caffeine + PhenylephrineFixed-dose combination · cough-cold Quashed S.O. 915(E) 10 March 2016 344 FDCs · Mar 2016 Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban
Nimesulide + Paracetamol + Levocetirizine + Phenylephrine + CaffeineFixed-dose combination · cough-cold Quashed S.O. 918(E) 10 March 2016 344 FDCs · Mar 2016 Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban
Dextromethorphan + Phenylephrine + Cetirizine + Paracetamol + CaffeineFixed-dose combination · cough-cold Quashed S.O. 929(E) 10 March 2016 344 FDCs · Mar 2016 Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban
Paracetamol + Phenylephrine + Levocetirizine + CaffeineFixed-dose combination · cough-cold Quashed S.O. 932(E) 10 March 2016 344 FDCs · Mar 2016 Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban
Cetirizine + Phenylephrine + Paracetamol + Ambroxol + CaffeineFixed-dose combination · cough-cold Quashed S.O. 947(E) 10 March 2016 344 FDCs · Mar 2016 Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban
Levocetirizine + Paracetamol + Phenylephrine + CaffeineFixed-dose combination · cough-cold Quashed S.O. 949(E) 10 March 2016 344 FDCs · Mar 2016 Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban
Caffeine + Paracetamol + Phenylephrine + ChlorpheniramineFixed-dose combination · cough-cold Under examination S.O. 950(E) 10 March 2016 344 FDCs · Mar 2016 Quashed by Delhi HC 1 Dec 2016; SC order 15.12.2017 treated it as a pre-1988 FDC, under examination with Expert Committee per CDSCO list as on 22.11.2021 (note 3#). 14 of these 15 were re-prohibited on 02.06.2023 (wave 2023-14).
Paracetamol + Phenylephrine + Triprolidine + CaffeineFixed-dose combination · cough-cold Quashed S.O. 953(E) 10 March 2016 344 FDCs · Mar 2016 Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban
Caffeine + Paracetamol + Phenylephrine + CetirizineFixed-dose combination · cough-cold Quashed S.O. 954(E) 10 March 2016 344 FDCs · Mar 2016 Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban
Paracetamol + Caffeine + Phenylephrine + ChlorpheniramineFixed-dose combination · cough-cold Quashed S.O. 959(E) 10 March 2016 344 FDCs · Mar 2016 Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban
Caffeine + Paracetamol + ChlorpheniramineFixed-dose combination · cough-cold Quashed S.O. 963(E) 10 March 2016 344 FDCs · Mar 2016 Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban
Paracetamol + Pseudoephedrine + Cetirizine + CaffeineFixed-dose combination · cough-cold Quashed S.O. 969(E) 10 March 2016 344 FDCs · Mar 2016 Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban
Cetirizine + Phenylephrine + Paracetamol + Caffeine + NimesulideFixed-dose combination · painkillers Quashed S.O. 985(E) 10 March 2016 344 FDCs · Mar 2016 Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban
Chlorpheniramine + Paracetamol + Pseudoephedrine + CaffeineFixed-dose combination · cough-cold Quashed S.O. 999(E) 10 March 2016 344 FDCs · Mar 2016 Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban
Ergotamine Tartrate + Belladonna Dry Extract + Caffeine + ParacetamolFixed-dose combination · painkillers Quashed S.O. 1027(E) 10 March 2016 344 FDCs · Mar 2016 Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban
Paracetamol + Propyphenazone + CaffeineFixed-dose combination · painkillers Quashed S.O. 1036(E) 10 March 2016 344 FDCs · Mar 2016 Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban
Phenylephrine + Chlorpheniramine + Paracetamol + Bromhexine + CaffeineFixed-dose combination · cough-cold Quashed S.O. 1047(E) 10 March 2016 344 FDCs · Mar 2016 Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban
Crude Ergot Preparations except Those containing Ergotamine, Caffeine, Analgesics, Antihistamines for the Treatment of Migraine, HeadachesFixed-dose combination · painkillers Banned GSR 304(E) 7 June 1991 Classic bans Entry text as substituted vide GSR 304(E) dated 1991-06-07; original 1983/1988 notification superseded.
Strychnine and Caffeine in TonicsFixed-dose combination · vitamins Banned GSR 578(E) 23 July 1983 Classic bans In force per CDSCO consumer list (1983-2017)

Products that failed lab tests

Product names as printed by the testing labs, grouped. Open a product to see every batch number.

Most recent failed batches

Product Batch Manufacturer Reason declared NSQ Tested by Alert
Paracetamol, Phenylephrine HCL, Caffeine and Disphenhydramine HCL Tablets UT-250656DMfg 2025-05 · Exp 2027-04 Ultra Drugs Pvt. Ltd. (Unit-II) HS No. 211Himachal Pradesh The sample fails in the Test for Description and DisintegrationDescription MDTL KathuaState lab May 2026
Paracetamol & Caffeine Tablets IP HRA25001Mfg 2025-04 · Exp 2027-03 Danish Healthcare (P) Ltd. 76/26-2B Assay and DissolutionAssay RDTL, Bellary, KarnatakaState lab May 2026
Aceclofenac, Paracetamol, Phenylephrine Hcl Cetirizine Hcl & Caffeine GT-25294AMfg 2025-08 · Exp 2028-07 Not applicable MisbrandadMisbranded SDTL, ChhattisgarhState lab May 2026
Paracetamol, Phenylephrine Hydrochloride Diphenhydramine, Hydrocloride & Caffeine Tablets YLT25023Mfg 2025-06 · Exp 2027-05 YL PharmaHimachal Pradesh The sample does not conform to the claim with respect to in Assay of Phenylephrine Hydrochloride & Caffeine (Anhydrous) (NIL).Assay DTL JaipurState lab Feb 2026
Paracetamol, Chlorpheniramine Maleate, Caffeine and Phenylephrine Hydrochloride Tablets MAAI20724Mfg 2024-07 · Exp 2027-06 Suraksha Pharma Pvt. LtdUttarakhand Test for Disintegration onlyDisintegration RDTL, Hubli, KarnatakaState lab Feb 2026
Paracetamol and Caffeine Tablets IP APSDN 2506Mfg 2025-04 · Exp 2027-03 Konis Pharmaceuticals Pv t. LtdHimachal Pradesh DescriptionDescription DTL, Madurai-19State lab Feb 2026
New unsyn Tablets Acetyl Salicyclic Acid BP 150mg Paracetamol BP 150mg, Caffeine (Anhydrous) BP 25mg Tablets 63Mfg 2023-08 · Exp 2026-07 National Pharmacetutical G-18/1Maharashtra DescriptionDescription FDAL, MumbaiState lab Dec 2025
Paracetamol, Phenylephrine Hcl, Caffeine & Diphenhydramine Hcl Tablets YLT25006Mfg 2025-01 · Exp 2026-12 YL PharmaHimachal Pradesh Identification & AssayAssay DTL ,Baddi, HPState lab Sep 2025
Paracetamol, Phenylphrine HCL, CPM & Caffeine Tablets (Goco-Plus) DPT-1223Mfg 2024-09 · Exp 2026-08 Dexibo Pharma Pvt. LtdUttarakhand DisintegrationDisintegration State Lab PuducherryState lab Jun 2025
Paracetamo l, Phenylephri ne HCl, Caffeine & Diphenhydr amine HCl Tablets (CINKOLD) SG034B0 3Mfg 2023-02 · Exp 2025-01 Sharun Pharmaceuticals Pvt.LtdPuducherry NOTE:(i) On the received sample, Presence of Spot defect was observed which should not be present as per DCC Guidelines on Not Of Standard Quality (NSQ) Drugs Approved in 1993 (Annexure A) Tablets vide serial No.(i) Presence of Spot/discoloration. (ii)The label of the container in the drug is mentioned as 'Approved colour used' but the common name of the permitted colour used in the formulation as prescribed under rule 127 (2) of the drug rule was not mentioned. vel - NSQLabelling State Lab PuducherryState lab Jan 2025
Caffeine Anhydrous BP CF/23/0007Mfg 2023-07 · Exp 2028-06 Bakul Aromatics and Chemicals Pvt. Ltd Spurious with respect to the Identification test for caffeineIdentification CDTL MumbaiCDSCO lab Nov 2023
Caffeine Citrate Injection USP 60mg/3ml I-5735Mfg 2022-12 · Exp 2024-11 Jakson Laboratories Pvt. LtdPunjab Sterility & Bacterial EndotoxinsSterility CDL KolkataCDSCO lab Sep 2023
Paracetamol, Phenylphrine Hydrochloride, Diphenhydramine Hydrochloride and Caffeine Tablets (Syscold Tablets) SPT?192Mfg 2022-01 · Exp 2023-12 Signoret Pharmaceuticals Pvt.LtdPunjab Disintegration test and Assay of Phenylephrine HydrochlorideAssay RDTL ChandigarhState lab May 2023
PCD COLD� (Paracetamol, Phenylephrine HCl, Caffeine & Diphenhydramine HCl Tablets) GLT-21213Mfg 2021-03 · Exp 2024-02 Gopal LifesciencesHimachal Pradesh DisintegrationDisintegration RDTL GuwahatiState lab Nov 2022
Paracetamol, Phenylephrine Hydrochloride, Caffeine and Diphenhydramine Hydrochloride (SNEZEE 500) TP1020810Mfg 2020-10 · Exp 2022-09 Maxrelief HealthcareHimachal Pradesh Identification and AssayAssay RDTL GuwahatiState lab Apr 2022
Showing 15 of 17 records

Holding a strip or bottle? The batch number is printed after "B. No." Check it against every alert. If it matches, return it to the pharmacy. What the labels mean: status guide.