Ingredient record · Diabetes medicine
Metformin: 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
58 entries containing Metformin are on India's banned-drugs list, and 24 are banned today. 75 batches of medicines containing Metformin failed a government lab test between March 2019 and September 2026, from 58 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
Not banned Is Metformin banned in India? Not banned · some combos halted (2025). Read the full status record
24
Banned combinations in force
34
Other listed orders (stayed, restricted, quashed)
75
Batches failed a lab test
Sep 2026
Latest lab alert
Is it banned? Our answer pages
Not banned · some combos halted (2025)
On the banned-drugs list
Metformin 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 |
|---|---|---|---|---|---|
| Metformin Hydrochloride 500mg (Extended Release) + Glimepiride 3mg + Dapagliflozin 10mg Film Coated Bilayered TabletsFixed-dose combination · diabetes | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 3 | 11 April 2025 | 35 FDCs · Apr 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
| Glimepiride 1mg + Metformin HCl 500mg TabletFixed-dose combination · diabetes | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 29 | 11 April 2025 | 35 FDCs · Apr 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
| Glimepiride 2mg + Metformin Hydrochloride (Sustained Release) 500mg + Voglibose 0.3mg TabletFixed-dose combination · diabetes | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 30 | 11 April 2025 | 35 FDCs · Apr 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
| Metformin Hydrochloride (Prolonged Release) 500mg + Voglibose 0.2mg TabletFixed-dose combination · diabetes | Ban revoked | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 31 | 11 April 2025 | 35 FDCs · Apr 2025 | Excluded from the 11.04.2025 list by CDSCO corrigendum dated 10.09.2025: found to be approved by CDSCO (recorded by Delhi HC on 14.07.2025). Originally: CDSCO direction to SLAs 11 Apr 2025, not a Section 26A ban. |
| Ursodeoxycholic Acid + Metformin HClFixed-dose combination · diabetes | Banned | S.O. 3304(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Glimepiride1mg/2mg/3mg + Pioglitazone15mg/15mg/15mg + Metformin1000mg/1000mg/1000mgFixed-dose combination · diabetes | Quashed | S.O. 4471(E) | 7 September 2018 | 328 FDCs · Sep 2018 | Quashed by Delhi HC order dated 13.02.2019; CDSCO appealed, sub judice (CDSCO list as on 22.11.2021, note 5#). |
| Glimepiride 1mg/2mg + Pioglitazone 15mg/15mg + Metformin 850mg/850mgFixed-dose combination · diabetes | Quashed | S.O. 4472(E) | 7 September 2018 | 328 FDCs · Sep 2018 | Quashed by Delhi HC order dated 13.02.2019; CDSCO appealed, sub judice (CDSCO list as on 22.11.2021, note 5#). |
| Pioglitazone 30mg + Metformin 500mgFixed-dose combination · diabetes | Quashed | S.O. 4479(E) | 7 September 2018 | 328 FDCs · Sep 2018 | Quashed by Delhi HC order dated 22.02.2019; CDSCO appealed, sub judice (CDSCO list as on 22.11.2021, note 5#). |
| Metformin + AtorvastatinFixed-dose combination · diabetes | Banned | S.O. 4453(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Metformin 1000/1000/500/500mg + Pioglitazone 7.5/7.5/7.5/7.5mg + Glimepiride 1/2/1/2mgFixed-dose combination · diabetes | Banned | S.O. 4467(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Gliclazide 80mg + Metformin 325 mgFixed-dose combination · diabetes | Banned | S.O. 4468(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Voglibose + Metformin + Chromium PicolinateFixed-dose combination · diabetes | Banned | S.O. 4469(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Pioglitazone 7.5/7.5mg + Metformin 500/1000mgFixed-dose combination · diabetes | Banned | S.O. 4470(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Metformin 850mg + Pioglitazone 7.5mg + Glimepiride 2mgFixed-dose combination · diabetes | Banned | S.O. 4473(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Metformin 850mg + Pioglitazone 7.5mg + Glimepiride1mgFixed-dose combination · diabetes | Banned | S.O. 4474(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Metformin 500mg/500mg + Gliclazide SR30mg/60mg + Pioglitazone7.5mg/7.5mgFixed-dose combination · diabetes | Banned | S.O. 4475(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Voglibose + Pioglitazone + MetforminFixed-dose combination · diabetes | Banned | S.O. 4476(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Metformin + BromocriptineFixed-dose combination · diabetes | Banned | S.O. 4477(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Metformin + Glimepiride + MethylcobalaminFixed-dose combination · diabetes | Banned | S.O. 4478(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Glimepiride + Pioglitazone + MetforminFixed-dose combination · diabetes | Banned | S.O. 815(E) as printed (2016 number repeated in the 2018 block of the CDSCO list), 2018 S.O. number not confirmed | 7 September 2018 | 328 FDCs · Sep 2018 | Listed in the 07.09.2018 block of the CDSCO list as on 22.11.2021 but printed with its 10.03.2016 notification number; the 2018 S.O. number (possibly the unlisted S.O. 4616(E)) must be VERIFIED against the Gazette. In force per CDSCO list as on 22.11.2021 |
| Glipizide2.5mg + Metformin 400mgFixed-dose combination · diabetes | Banned | S.O. 4480(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Pioglitazone 15mg + Metformin 850mgFixed-dose combination · diabetes | Banned | S.O. 4481(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Metformin ER + Gliclazide MR + VogliboseFixed-dose combination · diabetes | Banned | S.O. 4482(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Chromium Polynicotinate + Metformin HydrochlorideFixed-dose combination · diabetes | Banned | S.O. 4483(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Metformin Hydrochlopride + Gliclazide + Piogllitazone + Chromium PolynicotinateFixed-dose combination · diabetes | Banned | S.O. 4484(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Metformin + Gliclazide + Chromium PolynicotinateFixed-dose combination · diabetes | Banned | S.O. 4485(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Metformin (Sustained Release) 500mg + Pioglitazone15mg + Glimepiride 3mgFixed-dose combination · diabetes | Banned | S.O. 4486(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Metformin (SR) 500mg + Pioglitazone5mgFixed-dose combination · diabetes | Banned | S.O. 4487(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Gliclazide 40mg + Metformin 400mgFixed-dose combination · diabetes | Banned | S.O. 4682(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Telmisartan + MetforminFixed-dose combination · diabetes | Banned | S.O. 4694(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Benfotiamine + MetforminFixed-dose combination · diabetes | Banned | S.O. 4697(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Metformin + AtorvastatinFixed-dose combination · diabetes | Quashed | S.O. 785(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Metformin 1000/1000/500/500mg + Pioglitazone 7.5/7.5/7.5/7.5mg + Glimepiride 1/2/1/2mgFixed-dose combination · diabetes | Quashed | S.O. 802(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Gliclazide 80 mg + Metformin 325 mgFixed-dose combination · diabetes | Quashed | S.O. 803(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Voglibose + Metformin + Chromium PicolinateFixed-dose combination · diabetes | Quashed | S.O. 804(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Pioglitazone 7.5/7.5mg + Metformin 500/1000mgFixed-dose combination · diabetes | Quashed | S.O. 805(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Glimepiride 1mg/2mg/3mg + Pioglitazone 15mg/15mg/15mg + Metformin 1000mg/1000mg/1000mgFixed-dose combination · diabetes | Quashed | S.O. 806(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Glimepiride 1mg/2mg + Pioglitazone 15mg/15mg + Metformin 850mg/850mgFixed-dose combination · diabetes | Quashed | S.O. 807(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Metformin 850mg + Pioglitazone 7.5 mg + Glimepiride 2mgFixed-dose combination · diabetes | Quashed | S.O. 808(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Metformin 850mg + Pioglitazone 7.5 mg + Glimepiride 1mgFixed-dose combination · diabetes | Quashed | S.O. 809(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Metformin 500mg/500mg + Gliclazide SR 30mg/60mg + Pioglitazone 7.5mg/7.5mgFixed-dose combination · diabetes | Quashed | S.O. 810(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Voglibose + Pioglitazone + MetforminFixed-dose combination · diabetes | Quashed | S.O. 811(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Metformin + BromocriptineFixed-dose combination · diabetes | Quashed | S.O. 812(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Metformin + Glimepiride + MethylcobalaminFixed-dose combination · diabetes | Quashed | S.O. 813(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Pioglitazone 30 mg + Metformin 500mgFixed-dose combination · diabetes | Quashed | S.O. 814(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Glimepiride + Pioglitazone + MetforminFixed-dose combination · diabetes | Quashed | S.O. 815(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Glipizide 2.5mg + Metformin 400mgFixed-dose combination · diabetes | Quashed | S.O. 816(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Pioglitazone 15mg + Metformin 850 mgFixed-dose combination · diabetes | Quashed | S.O. 817(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Metformin ER + Gliclazidemr + VogliboseFixed-dose combination · diabetes | Quashed | S.O. 818(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Chromium Polynicotinate + Metformin HydrochlorideFixed-dose combination · diabetes | Quashed | S.O. 819(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Metformin Hydrochlopride + Gliclazide + Piogllitazone + Chromium PolynicotinateFixed-dose combination · diabetes | Quashed | S.O. 820(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Metformin + Gliclazide + Chromium PolynicotinateFixed-dose combination · diabetes | Quashed | S.O. 821(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Glibenclamide + Metformin (SR) + PioglitazoneFixed-dose combination · diabetes | Quashed | S.O. 822(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Metformin (Sustained Release) 500mg + Pioglitazone 15 mg + Glimepiride 3mgFixed-dose combination · diabetes | Quashed | S.O. 823(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Metformin (SR) 500mg + Pioglitazone 5mgFixed-dose combination · diabetes | Quashed | S.O. 824(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Gliclazide 40mg + Metformin 400mgFixed-dose combination · diabetes | Quashed | S.O. 1029(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Telmisartan + MetforminFixed-dose combination · diabetes | Quashed | S.O. 1041(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Benfotiamine + MetforminFixed-dose combination · diabetes | Quashed | S.O. 1044(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.
Top 30 of 37 products by number of batches.
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Metformin Tablets I.P. 500 mg | Batch SMF-103Mfg Jun 2025 · Exp May 2027 | MARC Life Sciences SikkimSikkim | TESTS PERFORMED FOR UNIFORMITY OF WEIGHT.Uniformity of weight/content | DTL, DelhiState lab | Sep 2026 |
| Glimepiride, Voglibose & Metformin HCL SR Tablets | Batch OT-250933Mfg Aug 2025 · Exp Jul 2027 | Orchid Biotech LtdDelhi | Assay of GlimepirideAssay | SDTL, Andhra Pradesh, VijayawadaState lab | Sep 2026 |
| Sitagliptin Phosphate and Metformin Hydrochloride Tablets (Sitarise-M) | Batch TG242142Mfg Dec 2024 · Exp Nov 2026 | Symbiosis Pharmaceuticals Pvt. Ltd. Suketi RoadHimachal Pradesh | Description and test for Uniformity of weight as per indian PharmacopoeiaDescription | DTL, Bengaluru, KarnatakaState lab | Aug 2026 |
| Metformin Hydrochloride Prolonged-Released and Glimepiride Tablets IP | Batch 60002727Mfg Mar 2026 · Exp Feb 2028 | USV Private LimitedGujarat | The sample does not conform to claim as per Manufacture's Specification with respect to the test for Dissolution of Metformin Hydrochloride.Dissolution | CDTL, IndoreCDSCO lab | Jul 2026 |
| Glimepiride, Ploglitazonehci & Metformin HCI (SR) Tablets | Batch DPT-016Mfg Apr 2025 · Exp Mar 2027 | Demexico Pharmaceuticals Pvt. LtdUttarakhand | The sample has been declared as NSQ as it does not conform to label claim with respect to Assay for Metformin Hydrochloride and PioglitazoneAssay | RDTL. Bellary KarnatakaState lab | Jul 2026 |
| Metformin Hydrochloride Prolonged Release and Glimepiride Tablets IP (500mg/2mg) | Batch PRT-250229Mfg Feb 2025 · Exp Jan 2027 | Preet Remedies LtdHimachal Pradesh | DescriptionDescription | DTL, Bengaluru, KarnatakaState lab | Jun 2026 |
| Voglibose, Glimepiride & Metformin HCl (SR) Tablets). | Batch TPT26010Mfg Jan 2026 · Exp Dec 2027 | Taj Pharma India LtdGujarat | Description: one out of 20 tablets blue layer half broken found. & Assay of Glimepiride IP- less than Prescribed limitAssay | SDTL, UttarakhandState lab | May 2026 |
| Teneligliptin & Metformin Hydrochloride Extended Release tablets IP | Batch T-2503098Mfg Mar 2025 · Exp Feb 2027 | Rivpra Formulation Pvt. LtdUttarakhand | The sample does not conform to I.P. with respect to the Dissolution and Assay of TeneligliptinAssay | CDL, KolkataCDSCO lab | May 2026 |
| Metformin Hydrochloride & Glimepiride Tablets (GLIMAFF-2 Tablets | Batch GVGT1138Mfg Oct 2025 · Exp Sep 2027 | Voizmed Pharma Pvt. LtdHimachal Pradesh | AssayAssay | RDTL, Bellary, KarnatakaState lab | May 2026 |
| Metformin HCl I.P. (as Prolonged Release Form & Glimepiride I.P | Batch TPT26008Mfg Jan 2026 · Exp Dec 2027 | Taj Pharma India LtdGujarat | Assay of Glimepiride IP- less than Prescribed limitAssay | SDTL, UttarakhandState lab | May 2026 |
| Metformin Hydrochloride Prolonged Release Tablets IP 500mg | Batch TB-167Mfg Mar 2026 · Exp Feb 2028 | Carewell Steuart Pharma Pvt.Ltd | DescriptionDescription | DTL, Chennai-06State lab | May 2026 |
| Gliclazide & Metformin hydrochloride sustained release tablets | Batch 475TGC002Mfg Jan 2026 · Exp Dec 2027 | Swiss Garnier Life SciencesHimachal Pradesh | ContentOther | DTL, Madurai-19State lab | May 2026 |
| Sitagliptin & Metformin Prolonged-Release Tablets BP | Batch AXC0111Mfg Jul 2025 · Exp Jun 2027 | Exemed Pharmaceuticals | The sample does not conform to B.P. with respect to the Assay of Sitagliptin.Assay | CDL, KolkataCDSCO lab | Apr 2026 |
| Metformin Hydrochloride Prolonged Release and Glimepiride Tablets IP | Batch T5107Mfg Jul 2025 · Exp Jun 2027 | Merril Pharma Pvt. LtdGujarat | The sample does not conform to IP with respect to the Test of Dissolution for Glimepiride.Dissolution | CDL, KolkataCDSCO lab | Apr 2026 |
| Metformin Hydrochloride Prolonged Release and Glimepiride Tablets IP | Batch T5110Mfg Jul 2025 · Exp Jun 2027 | Merril Pharma Pvt. LtdGujarat | The sample does not conform to IP with respect to the test of Dissolution of Glimepiride.Dissolution | CDL, KolkataCDSCO lab | Apr 2026 |
Showing 15 of 75 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.