Ingredient record · Steroid
Prednisolone: 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
2 entries containing Prednisolone are on India's banned-drugs list, and 1 is banned today. 20 batches of medicines containing Prednisolone failed a government lab test between July 2019 and April 2026, from 17 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 | 10 | 9 | Mar 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 |
|---|---|---|---|---|---|
| Methyl Prednisolone Tablets IP 4mg | B2508249BMfg 2025-08 · Exp 2027-07 | Bymaa Laboratories Private LimitedPuducherry | The sample fails the test 'Dissolution' as per IPDissolution | DTL ThiruvananthapuramState lab | Apr 2026 |
| Prednisolone Tablets IP 10mg | PHTC-02Mfg 2025-01 · Exp 2026-12 | Nestor Pharmaceuticals LimitedHaryana | DissolutionDissolution | DTL, ThiruvananthapuramState lab | Mar 2026 |
| Prednisolone Tablets IP 5mg | ATS-25001Mfg 2025-05 · Exp 2028-04 | Okvik Pharma Pvt. Ltd. 1913-KHaryana | AssayAssay | Uttar PradeshState lab | Jan 2026 |
| Prednisolone Tablets IP 20mg(Prednimeg-20) | ZRST-2403Mfg 2025-05 · Exp 2027-04 | ZRS Pharmaceuticals India Pvt. Ltd | Incorrect labellingLabelling | DTL, PuducherryState lab | Dec 2025 |
| Prednisolone Sodium Phosphate Drops Reslone (Drops 10ml) | L-250705Mfg 2025-07 · Exp 2027-06 | 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 | 2.4000000000000001E+29Mfg 2024-05 · Exp 2026-04 | Contacare Ophthalmics and DiagnosticsGujarat | Assay for Predniosolone acetateAssay | DTL, Bengaluru, KarnatakaState lab | Nov 2025 |
| Prednisolone Tablets I.P. 10 mg | T240368Mfg 2024-07 · Exp 2026-06 | Sunlife Sciences 130Uttarakhand | AssayAssay | Drug Control Department ChhattisgarhState lab | Jul 2025 |
| Prednisolone Tablets IP 10 mg | PRDT- 1007Mfg 2024-11 · Exp 2024-10 | Wings Biotech LLPHimachal Pradesh | Assay of PrednisoloneAssay | RDTL ChandigarhCDSCO lab | Jun 2024 |
| Prednisolone TabletsIP10mg | PRDT- 1007Mfg 2022-11 · Exp 2024-10 | 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) | 1223-51Mfg 2023-02 · Exp 2025-01 | Zee Laboratories LtdHimachal Pradesh | Assay of Prednisolone AcetateAssay | CDL KolkataCDSCO lab | Jan 2024 |
| MOXIZEE-P Eye Drops (Moxifloxacin & Prednisolone Acetate Eye Drops) | 1223-319Mfg 2023-08 · Exp 2025-07 | Zee Laboratories LtdHimachal Pradesh | Assay of PrednisoloneAssay | CDL KolkataCDSCO lab | Dec 2023 |
| Prednisolone Tablets I.P. 5 mg | PDT1009Mfg 2022-10 · Exp 2024-09 | Unicure India LtdUttar Pradesh | Related SubstancesRelated substances | CDL KolkataCDSCO lab | Jun 2023 |
| IO-Pred-S Eye Drops (Prednisolone Acetate Ophthalmic Suspension USP) | N22L17Mfg 2022-12 · Exp 2024-11 | Indiana Ophthalmics LLPGujarat | Assay of Prednisolone AcetateAssay | CDL KolkataCDSCO lab | Jun 2023 |
| IO-Pred-S Eye Drops (Prednisolone Acetate Ophthalmic Suspension USP) | N22L18Mfg 2022-12 · Exp 2024-11 | Indiana Ophthalmics LLPGujarat | Assay of Prednisolone AcetateAssay | CDL KolkataCDSCO lab | Jun 2023 |
| Prednisolone Tablets IP 5 mg | DTB-130Mfg 2022-01 · Exp 2023-12 | Ipca Laboratories LtdSikkim | Related SubstancesRelated substances | RDTL ChandigarhCDSCO lab | Jan 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.