Ingredient record · Steroid
Prednisolone: 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
2 entries containing Prednisolone are on India's banned-drugs list, and 1 is banned today. 21 batches of medicines containing Prednisolone failed a government lab test between July 2019 and August 2026, from 18 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
On the banned-drugs list
Prednisolone 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 |
|---|---|---|---|---|---|
| Cephalexin + Neomycin + PrednisoloneFixed-dose combination · antibiotics | Banned | S.O. 4448(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Cephalexin + Neomycin + PrednisoloneFixed-dose combination · antibiotics | Quashed | S.O. 780(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.
| Product | Batches | Makers | Latest |
|---|---|---|---|
| Prednisolone | 11 | 10 | Aug 2026 |
| Methyl Prednisolone | 1 | 1 | Apr 2026 |
| Prednisolone Sodium Phosphate Reslone | 1 | 1 | Dec 2025 |
| Prednisolone Acetate Opthalmic | 1 | 1 | Nov 2025 |
| Prednisolone Tabletsip | 1 | 1 | May 2024 |
| Moxifloxacin Prednisolone Acetate | 1 | 1 | Jan 2024 |
| Moxizee P | 1 | 1 | Dec 2023 |
| Io Pred S | 1 | 1 | Jun 2023 |
| Io Pred S Prednisolone Acetate Ophthalmic | 1 | 1 | Jun 2023 |
| P Solone | 1 | 1 | Jul 2022 |
| Prednisolone Acetate Moxifloxacin Ophthalmic M Floxin P | 1 | 1 | Jul 2019 |
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Prednisolone Tablets IP | Batch PRD2516Mfg Dec 2025 · Exp Nov 2027 | Concord Drugs LtdTelangana | The sample is not of standard quality for the reason stated under Description of the tablets.Description | RDTL, GuwahatiCDSCO lab | Aug 2026 |
| Methyl Prednisolone Tablets IP 4mg | Batch B2508249BMfg Aug 2025 · Exp Jul 2027 | Bymaa Laboratories Private LimitedPuducherry | The sample fails the test 'Dissolution' as per IPDissolution | DTL ThiruvananthapuramState lab | Apr 2026 |
| Prednisolone Tablets IP 10mg | Batch PHTC-02Mfg Jan 2025 · Exp Dec 2026 | Nestor Pharmaceuticals LimitedHaryana | DissolutionDissolution | DTL, ThiruvananthapuramState lab | Mar 2026 |
| Prednisolone Tablets IP 5mg | Batch ATS-25001Mfg May 2025 · Exp Apr 2028 | Okvik Pharma Pvt. Ltd. 1913-KHaryana | AssayAssay | Uttar PradeshState lab | Jan 2026 |
| Prednisolone Tablets IP 20mg(Prednimeg-20) | Batch ZRST-2403Mfg May 2025 · Exp Apr 2027 | ZRS Pharmaceuticals India Pvt. Ltd | Incorrect labellingLabelling | DTL, PuducherryState lab | Dec 2025 |
| Prednisolone Sodium Phosphate Drops Reslone (Drops 10ml) | Batch L-250705Mfg Jul 2025 · Exp Jun 2027 | Dr. Pal'S Pharmaceuticals 10B-1Uttarakhand | The sample received does not conform with respect to The test for weight per ml.Weight | CDTL, MumbaiCDSCO lab | Dec 2025 |
| Prednisolone Acetate Opthalmic Suspension USP | Batch 2.4000000000000001E+29Mfg May 2024 · Exp Apr 2026 | Contacare Ophthalmics and DiagnosticsGujarat | Assay for Predniosolone acetateAssay | DTL, Bengaluru, KarnatakaState lab | Nov 2025 |
| Prednisolone Tablets I.P. 10 mg | Batch T240368Mfg Jul 2024 · Exp Jun 2026 | Sunlife Sciences 130Uttarakhand | AssayAssay | Drug Control Department ChhattisgarhState lab | Jul 2025 |
| Prednisolone Tablets IP 10 mg | Batch PRDT- 1007Mfg Nov 2024 · Exp Oct 2024 | Wings Biotech LLPHimachal Pradesh | Assay of PrednisoloneAssay | RDTL ChandigarhCDSCO lab | Jun 2024 |
| Prednisolone TabletsIP10mg | Batch PRDT- 1007Mfg Nov 2022 · Exp Oct 2024 | Wingsbiotech LLPHimachal Pradesh | The sample does not conforms to claim as per IP 2018 and Addendum 2021 in respect to the Assay of PrednisoloneAssay | RDTL ChandigarhCDSCO lab | May 2024 |
| Moxifloxacin & Prednisolone Acetate Eye Drops (MOXIZEE- P Eye Drops) | Batch 1223-51Mfg Feb 2023 · Exp Jan 2025 | Zee Laboratories LtdHimachal Pradesh | Assay of Prednisolone AcetateAssay | CDL KolkataCDSCO lab | Jan 2024 |
| MOXIZEE-P Eye Drops (Moxifloxacin & Prednisolone Acetate Eye Drops) | Batch 1223-319Mfg Aug 2023 · Exp Jul 2025 | Zee Laboratories LtdHimachal Pradesh | Assay of PrednisoloneAssay | CDL KolkataCDSCO lab | Dec 2023 |
| Prednisolone Tablets I.P. 5 mg | Batch PDT1009Mfg Oct 2022 · Exp Sep 2024 | Unicure India LtdUttar Pradesh | Related SubstancesRelated substances | CDL KolkataCDSCO lab | Jun 2023 |
| IO-Pred-S Eye Drops (Prednisolone Acetate Ophthalmic Suspension USP) | Batch N22L17Mfg Dec 2022 · Exp Nov 2024 | Indiana Ophthalmics LLPGujarat | Assay of Prednisolone AcetateAssay | CDL KolkataCDSCO lab | Jun 2023 |
| IO-Pred-S Eye Drops (Prednisolone Acetate Ophthalmic Suspension USP) | Batch N22L18Mfg Dec 2022 · Exp Nov 2024 | Indiana Ophthalmics LLPGujarat | Assay of Prednisolone AcetateAssay | CDL KolkataCDSCO lab | Jun 2023 |
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.