Ingredient record · Diabetes medicine (DPP-4 inhibitor)
Sitagliptin: 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
No combination containing Sitagliptin is on India's banned-drugs list. 7 batches of medicines containing Sitagliptin failed a government lab test between February 2025 and April 2026, from 6 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
On the banned-drugs list
Sitagliptin 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.
No entry containing Sitagliptin is on the list compiled from CDSCO's Section 26A notifications (1983 to 2026). That is not a statement that every product containing it is safe.
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 |
|---|---|---|---|
| Sitagliptin Metformin + | 3 | 3 | Feb 2026 |
| Sitagliptin Metformin Prolonged Release | 1 | 1 | Apr 2026 |
| Sitagliptin | 1 | 1 | Feb 2025 |
| Sitagliptin Phoshpate | 1 | 1 | Feb 2025 |
| Sitagliptin Phosphate + Metformin | 1 | 1 | Feb 2025 |
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Sitagliptin & Metformin Prolonged-Release Tablets BP | AXC0111Mfg 2025-07 · Exp 2027-06 | Exemed Pharmaceuticals | The sample does not conform to B.P. with respect to the Assay of Sitagliptin.Assay | CDL, KolkataCDSCO lab | Apr 2026 |
| Metformin & Sitagliptin Tablets BP | TMSG-017Mfg 2025-07 · Exp 2027-06 | J.P IndustriesHimachal Pradesh | Sample fails the test Assay of Sitagliptin and Dissolution of Metformin Hydrochloride and Sitagliptin as per BP, as specified in the in the laboratory protocol.Assay | DTL ThiruvananthapuramState lab | Feb 2026 |
| Sitagliptin & Metformin Tablets 50mg + 1000mg (Sitajack-M) | T-2672Mfg 2024-09 · Exp 2026-08 | Jackson Laboratories Pvt.Ltd 22-24Punjab | Assay of SitagliptinAssay | CDL KolkataCDSCO lab | Jun 2025 |
| Sitagliptin & Metformin Tablets 50 mg + 1000 mg (Sitajack-M ) | T-2916Mfg 2024-09 · Exp 2026-08 | Jackson Laboratories Pvt. LtdPunjab | Assay of SitagliptinAssay | CDL, KolkataCDSCO lab | May 2025 |
| Sitagliptin Phoshpate Tablets I.P. (50 mg) | MT243714Mfg 2024-11 · Exp 2026-10 | Mascot Health Series Pvt. LtdUttarakhand | Assay of Sitagliptin PhosphateAssay | CDL KolkataCDSCO lab | Feb 2025 |
| SITAGLIPTIN PHOSPHATE 50 + METFORMIN 500MG TABLETS (LanZsita-M) | SP/T/76 1Mfg ? · Exp ? | Signoret Pharmaceuticals Pvt.Ltd | For the received sample SITAGLIPTIN PHOSPHATE 50 + METFORMIN 500MG TABLETS (LanZsita-M), The label is mentioned as ?Approved colour used? but common name of the permitted colour used in the formulation as prescribed under rule 127(2) of the Drugs Rules,1945 was not mentioned.-MisbrandedMisbranded | PuducherryState lab | Feb 2025 |
| SITAGLIPTIN IP 100mg TABLETS (LanZsita 100) | SP/T/83 8Mfg ? · Exp ? | Signoret Pharmaceuticals Pvt.Ltd | For the received sample Sitagliptin IP 100mg Tablets (LanZsita 100), The label is mentioned as ?Approved colour used? but common name of the permitted colour used in the formulation as prescribed under rule 127(2) of the Drugs Rules ,1945 was not mentioned.- MisbrandedMisbranded | PuducherryState lab | Feb 2025 |
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.