Ingredient record · Acid reducer (H2 blocker)
Famotidine: bans, restrictions and failed batches in India
Last checked 3 November 2026. Sources: CDSCO banned-drugs notifications and monthly NSQ alerts, Jan 2019 to Sep 2026
12 entries containing Famotidine are on India's banned-drugs list, and 6 are banned today. 1 batches of medicines containing Famotidine failed a government lab test between September 2026 and September 2026, from 1 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
On the banned-drugs list
Famotidine 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 / combination | Action | Notification | Date | Order | Status note |
|---|---|---|---|---|---|
| Diclofenac + Paracetamol + Chlorzoxazone + FamotidineFixed-dose combination · painkillers | Banned | S.O. 4387(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Paracetamol + Diclofenac + FamotidineFixed-dose combination · painkillers | Banned | S.O. 4390(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Aceclofenac + Paracetamol + FamotidineFixed-dose combination · painkillers | Banned | S.O. 4414(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Magaldrat + Famotidine + SimethiconeFixed-dose combination · gi | Banned | S.O. 4497(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Famotidine + Oxytacaine + MagaldrateFixed-dose combination · gi | Banned | S.O. 4503(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Oxetacaine + Magaldrate + FamotidineFixed-dose combination · gi | Banned | S.O. 4512(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Diclofenac + Paracetamol + Chlorzoxazone + FamotidineFixed-dose combination · painkillers | Quashed | S.O. 715(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Paracetamol + Diclofenac + FamotidineFixed-dose combination · painkillers | Quashed | S.O. 718(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Aceclofenac + Paracetamol + FamotidineFixed-dose combination · painkillers | Quashed | S.O. 744(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Magaldrate + Famotidine + SimethiconeFixed-dose combination · gi | Quashed | S.O. 834(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Famotidine + Oxytacaine + MagaldrateFixed-dose combination · gi | Quashed | S.O. 840(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Oxetacaine + Magaldrate + FamotidineFixed-dose combination · gi | Quashed | S.O. 849(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
Products that failed lab tests
Product names as printed by the testing labs, grouped. Open a product to see every batch number.
| Product | Batches | Makers | Latest |
|---|---|---|---|
| Famotidine | 1 | 1 | Sep 2026 |
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Famotidine Tablets USP 40 mg | Batch KT-26012Mfg Mar 2026 · Exp Feb 2028 | Asuwaldi Pharmaceuticals | 1) The Content of Famotidine in the Sample is less (i.e. 78.98% of labelled Amount) than the USP Limit. (USP Limit-Not Less than 90.0% and not more than 110.0% of labelled Amount). 2) The Sample does not Comply with USP Requirements for the Test for Uniformity of Dosage units and Dissolution.Dissolution | FDAL, M. S Chhatrapatri Sambhajinagar, F.D.A Mahrasthra StateState lab | Sep 2026 |
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.