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Pregabalin: 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

1 entry containing Pregabalin is on India's banned-drugs list, and 0 are banned today. 25 batches of medicines containing Pregabalin failed a government lab test between August 2019 and August 2026, from 21 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.

Not banned Is Pregabalin banned in India? Not banned · Schedule H1 notified (2026). Read the full status record

0
Banned combinations in force
1
Other listed orders (stayed, restricted, quashed)
25
Batches failed a lab test
Aug 2026
Latest lab alert

Is it banned? Our answer pages

Not banned · Schedule H1 notified (2026)

On the banned-drugs list

Pregabalin 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
Pregabalin (SR) 75mg + Nortriptyline 10mg + Vitamin D3 2000IU + Mecobalamin 1500mcg TabletFixed-dose combination · vitamins Halted CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 12 11 April 2025 35 FDCs · Apr 2025 CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban

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
Pregabalin Sustained Release Tablets Batch VGT261113Mfg Mar 2026 · Exp Feb 2028 Vrindavan GlobalHimachal Pradesh The Sample failed in Assay (i.e. Label Claim) of Pregabalin as mentioned under Standards 1940 and Rules for Patent there under.Assay SDTL, Andhra PradeshState lab Aug 2026
Pregabalin IP 75mg, Nortripyline 10mg and Methylcobalamin IP 1500mcg, Batch ADT252729AMfg Oct 2025 · Exp Sep 2027 Astonea Labs Pvt. LtdHaryana The content of Methylcobalamin found to be 668.61 mcg per tablet (44.574%) against labelled claim of 1500 mcg per tablet.Labelling Govt Analyst PunjabState lab Jul 2026
Pregabalin Capsules IP 300mg Batch DMC-260508AMfg May 2026 · Exp Apr 2028 Divine Medicare The Contents of Pregabali found to be 211.16mg/Capsule against the claim of 300.0mg/Capsule.Other Govt Analyst PunjabState lab Jul 2026
Pregabalin capsules IP 300 mg Batch SC2602602Mfg Feb 2026 · Exp Jan 2028 Scout Lifescience Pvt. LtdHaryana The sample received does not conform to the I.P. 2022 standard with respect to the test for Dissolution and DescriptionDissolution CDTL, MumbaiCDSCO lab May 2026
Pregabalin & Nortriptyline Tablets Batch ST25417CMfg Nov 2025 · Exp Oct 2027 Sahika Pharmaceuticals Pvt. LtdHimachal Pradesh The sample does not conform to Manufacturer's Specification with respect to Assay of PregabalinAssay CDL, KolkataCDSCO lab May 2026
Pregabalin, L-Methyl folate Calcium, Pyridoxal 5 Phosphate, Alpha lipoic acid & Methylcobalamin Tablets Batch MT-250016Mfg Jan 2025 · Exp Dec 2026 Matins Healthcare Pvt. LtdUttarakhand Test for DisintegrationDisintegration DTL, Bengaluru, KarnatakaState lab Mar 2026
Pregabalin & Methylcobalamin Capsules IP Batch PGC2508006CMfg Aug 2025 · Exp Jan 2027 Asterisk Healthcare DissolutionDissolution SDTL, PunjabState lab Mar 2026
Pregabalin & Methylcobalamin Capsule IP Batch 25DC015AMfg Aug 2025 · Exp Jan 2027 Mas Kashmik Formulation Pvt. Ltd. Pf-13Gujarat The content of MethylcobalminOther FDAL, MumbaiState lab Mar 2026
Pregabalin capsules IP 300mg Batch LPC25138Mfg Dec 2025 · Exp Nov 2027 Levotic Pharma The contents of Pregabalin found to be 345.40mg per Capsule (115.13%) against labeled claim of 300.0mg per capsule.Labelling SDTL, PunjabState lab Feb 2026
Pregabalin & Nortriptyline Tablets Batch PT-042515Mfg Apr 2025 · Exp Mar 2027 Primus PharmaceuticalsHimachal Pradesh The sample does not conform to the claim with respect to Assay in Nortriptyline.Assay DTL JaipurState lab Jan 2026
Pregabaline & Nortriptyline Tablets (DGABA-N Tablets,) Batch VGT242301BMfg Nov 2024 · Exp Oct 2026 Vrindavan GlobalHimachal Pradesh Misbranded.Misbranded DCL TelanganaState lab Dec 2025
Pregabalin & Methlcobalamin Capsules IP (Neujan Capsules) Batch MMC-1957Mfg Jan 2024 · Exp Dec 2025 Mayoford PharmaHimachal Pradesh Test for Uniformity of WeightUniformity of weight/content DTL, Bengaluru, KarnatakaState lab Oct 2025
Baptar NM Tablet (Pregabalin Methylcobalamin & Nortriptyline Tablets) Batch UGT-25134EMfg Jan 2025 · Exp Dec 2026 Ultra Drugs Pvt. LtdHimachal Pradesh AssayAssay DTL Baddi H.PState lab Oct 2025
PREGABALIN AND METHYLCOBALA MIN CAPSULES (Amalin Plus) Batch MDP- 774Mfg ? · Exp ? Medinok Healthcare Pvt. LtdPuducherry The sample received is labelled as PREGABALIN AND METHYLCOBALAMIN CAPSULES, however PREGABALIN AND METHYLCOBALAMIN CAPSULES is an official IP monograph (2022) hence should be labelled as PREGABALIN AND METHYLCOBALAMIN CAPSULES IP- MisbrandedMisbranded PuducherryState lab Feb 2025
Pregabalin (SR) & Methylcobal amin Tablet (Mecoben ? PG) Batch MP - 240724Mfg Oct 2024 · Exp Sep 2026 Medistark Biotech Pvt. Ltd. R.S.No. 68/4 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. - MisbrandedMisbranded State Lab PuducherryState lab Jan 2025
Showing 15 of 25 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.