Ingredient record · Antidepressant, also used for nerve pain
Amitriptyline: 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
No combination containing Amitriptyline is on India's banned-drugs list. 14 batches of medicines containing Amitriptyline failed a government lab test between January 2021 and June 2026, from 11 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
On the banned-drugs list
Amitriptyline 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 Amitriptyline 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 |
|---|---|---|---|
| Amitriptyline | 9 | 6 | Jun 2026 |
| Amitriptyline Hydrochloride | 1 | 1 | Dec 2025 |
| Amitriptyline Hcl Chlordiazepoxide | 1 | 1 | Apr 2025 |
| Gabapentin Amitriptyline Hcl | 1 | 1 | Nov 2023 |
| Amitryn C | 1 | 1 | Sep 2022 |
| Chlordiazepoxide Amitriptyline Hydrocholoride Libotryp | 1 | 1 | Aug 2022 |
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Amitriptyline Tablets IP 25 mg | Batch GAMT4Mfg Oct 2025 · Exp Sep 2027 | Super Formulations Pvt. Ltd | ContentOther | DTL, Madurai-19State lab | Jun 2026 |
| Amitriptyline Tablets IP 25mg | Batch VSPT2545Mfg Sep 2025 · Exp Aug 2027 | Vertex Pharma ChemicalsPuducherry | DescriptionDescription | DTL, Bengaluru, KarnatakaState lab | Mar 2026 |
| Amitriptyline Tablets IP | Batch DRT24032Mfg Feb 2024 · Exp Jan 2026 | Eastern HealthcareUttarakhand | The sample does not conform to I.P. in respect of the test Assay performed.Assay | West BengalState lab | Jan 2026 |
| Amitriptyline Hydrochloride Tablets IP 25mg | Batch ATJ-06Mfg Nov 2023 · Exp Oct 2026 | Argon Remedies Pvt. LtdUttarakhand | Failed Description (Capping & Cracking)Description | DTL, PuducherryState lab | Dec 2025 |
| Amitriptyline Tablets IP 25mg | Batch GAMT2Mfg Jun 2025 · Exp May 2027 | Super Formulations Pvt. Ltd | ContentOther | Drugs Testing Laboratory, Madurai-19State lab | Nov 2025 |
| Amitriptyline Tablets IP 25 mg | Batch AMT1305Mfg May 2025 · Exp Apr 2027 | Unicure India LtdUttar Pradesh | UniformityUniformity of weight/content | Drugs Testing Laboratory, Madurai-19State lab | Nov 2025 |
| Amitriptyline Tablets IP 25 mg | Batch GAMT1Mfg May 2025 · Exp Apr 2027 | Super Formulations Pvt. Ltd | ContentOther | Drugs Testing Laboratory, Madurai-19State lab | Nov 2025 |
| Amitriptyline Tablets IP | Batch DRT25096Mfg Apr 2025 · Exp Mar 2027 | Eastern HealthcareUttarakhand | The sample does not conform to claim as per IP 2022 in respect to the Test of DescriptionDescription | RDTL,ChandigarhCDSCO lab | Nov 2025 |
| Amitriptyline HCl & Chlordiazepoxide Tablets USP (AMTOPIC-PLUS) | Batch N2402062Mfg Feb 2024 · Exp Jan 2026 | Talent HealthcareUttarakhand | Assay for Amitriptyline onlyAssay | State Lab KarnatakaState lab | Apr 2025 |
| Amitriptyline Tablets IP 25mg | Batch TA24159Mfg Apr 2024 · Exp Mar 2026 | Saintlife Pharmaceuticals LtdUttarakhand | Sample does not conform to IP specification for tablets with respect to Definition.Other | DTL ChennaiState lab | Dec 2024 |
| Gabapentin & Amitriptyline HCl Tablets (GABAMER AT) | Batch T-230420Mfg Apr 2023 · Exp Mar 2025 | Vilin Bio Med LtdUttarakhand | Assay of Amitriptyline HydrochlorideAssay | CDL KolkataCDSCO lab | Nov 2023 |
| AMITRYN-C (Chlordiazepoxide and Amitriptyline Hydrochloride Tablets U.S.P.) | Batch AC2103Mfg Jun 2021 · Exp May 2024 | K.C. LaboratoriesGujarat | Assay of ChlordiazepoxideAssay | RDTL GuwahatiState lab | Sep 2022 |
| Chlordiazepoxide 5 mg & Amitriptyline Hydrocholoride 12.5mg Tablets USP Libotryp | Batch D2050026Mfg Dec 2020 · Exp Nov 2023 | Wockhardt LimitedHimachal Pradesh | Assay of ChlordiazepoxideAssay | RDTL GuwahatiState lab | Aug 2022 |
| Amitriptyline Tablets I.P. | Batch TAMF-026Mfg Mar 2020 · Exp Feb 2022 | Medipol Pharmaceutical India Pvt. LtdHimachal Pradesh | DescriptionDescription | CDL KolkataCDSCO lab | Jan 2021 |
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.