Manufacturer record
Alkem Laboratories Ltd: regulatory record
Last checked 3 November 2026. Source: CDSCO monthly NSQ alerts and state drug-testing laboratories
3 batches manufactured by Alkem Laboratories Ltd (Himachal Pradesh) were declared Not of Standard Quality between May 2023 and September 2026. Records are batch-specific findings by government laboratories as published in CDSCO's monthly alerts; where a company has stated that a flagged batch was counterfeit, that statement is noted when reported.
Most recent flagged batch: 25281124, Omeprazole Gastro-resistant Capsules IP 20 mg (exp May 2027). LUCKNOW, Uttar Pradesh (state lab) found it not of standard quality: The sample does not conform to IP in respect of Dissolution. Listed in the September 2026 alert.
Records by type
3 records linked to Alkem Laboratories Ltd in the datasets we hold. A zero means nothing is on record in those datasets, not that nothing ever happened. What the labels mean.
CDSCO drug alerts: Not of Standard Quality and spurious drugs
Scope. A company appearing here is not a finding that its products are unsafe. Regulatory actions can apply to one batch, one formulation, one period or one state. Always check the linked government document for the current position, and tell us if something is out of date. How we label records.
Flagged batches per year
All flagged batches
| Product | Batch | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|
| Omeprazole Gastro-resistant Capsules IP 20 mg | Batch 25281124Mfg Jun 2025 · Exp May 2027 | The sample does not conform to IP in respect of DissolutionDissolution | LUCKNOW, Uttar PradeshState lab | Sep 2026 |
| Amlodipine Besylate Tablets IP 5mg (AMLOGEN-5) | Batch 24230171Mfg Aug 2024 · Exp Jul 2026 | Incorrect labellingLabelling | DTL, PuducherryState lab | Oct 2025 |
| AMOXICILLIN CAPSULES IP (ALMOX-500) | Batch 22281692Mfg Jul 2022 · Exp Jun 2024 | AssayAssay | CDTL HyderabadCDSCO lab | May 2023 |
Right of reply. Manufacturers may submit a response or a laboratory re-test result; it is published unedited alongside this record. Submit a response.