Ingredient record · Vitamin B9, often combined with iron
Folic acid: 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
12 entries containing Folic acid are on India's banned-drugs list, and 7 are banned today. 197 batches of medicines containing Folic acid failed a government lab test between March 2019 and September 2026, from 116 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
On the banned-drugs list
Folic acid 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 |
|---|---|---|---|---|---|
| Dehydroepiandrosterone 75mg (Sustained Release) + Folic Acid 4.5mg TabletFixed-dose combination · vitamins | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 14 | 11 April 2025 | 35 FDCs · Apr 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
| Benfotiamine + Silymarin + L-Ornithine L-Aspartate + Sodium Selenite + Folic Acid + Pyridoxine HydrochlorideFixed-dose combination · vitamins | Banned | S.O. 3287(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Silymarin + Pyridoxine HCl + Cyanocobalamin + Niacinamide + Folic AcidFixed-dose combination · vitamins | Banned | S.O. 3297(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Silymarin + Vitamin B6 + Vitamin B12 + Niacinamide + Folic Acid + Tricholine CitrateFixed-dose combination · vitamins | Banned | S.O. 3298(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Atorvastatin + Vitamin D3 + Folic Acid Vitamin B12 + PyridoxineFixed-dose combination · vitamins | Banned | S.O. 4452(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Clomifene Citrate + Ubidecarenone + Zinc + Folic Acid + Methylcobalamin + Pyridoxine + Lycopene + Selenium + Levocarnitine Tartrate + L-ArginineFixed-dose combination · vitamins | Banned | S.O. 4519(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Thyroxine + Pyridoxine + Folic AcidFixed-dose combination · vitamins | Banned | S.O. 4520(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Ammonium Citrate + Vitamin B12 + Folic Acid + Zinc SulphateFixed-dose combination · vitamins | Banned | S.O. 4695(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Atorvastatin + Vitamin D3 + Folic Acid + Vitamin B12 + PyridoxineFixed-dose combination · vitamins | Quashed | S.O. 784(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Clomifene Citrate + Ubidecarenone + Zinc + Folic Acid + Methylcobalamin + Pyridoxine + Lycopene + Selenium + Levocarnitinetartrate + L-ArginineFixed-dose combination · vitamins | Quashed | S.O. 856(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Thyroxine + Pyridoxine + Folic AcidFixed-dose combination · vitamins | Quashed | S.O. 857(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Ammonium Citrate + Vitamin B 12 + Folic Acid + Zinc SulphateFixed-dose combination · vitamins | Quashed | S.O. 1042(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.
Top 30 of 79 products by number of batches.
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| L-Carnitine L-Tartrate, Mecobalamin & Folic Acid Tablets | Batch B95Z020Mfg Feb 2026 · Exp Jan 2028 | Mankind Pharma LtdSikkim | The sample gave identity test Negative for Mecobalamin & Folic Acid, Hence spuriousSpurious | LUCKNOW, Uttar PradeshState lab | Sep 2026 |
| L-Carnitine L-Tartrate, Mecobalamin & Folic Acid Tablets | Batch B95Y032Mfg Mar 2025 · Exp Feb 2027 | Mankind Pharma LtdSikkim | The sample gives Negative Identity test for Mecobalamin & Folic Acid, Hence the sample is SpuriouOther | LUCKNOW, Uttar PradeshState lab | Sep 2026 |
| Folic acid & Ferrous Sulphate Syrup Ip | Batch FSF-220Mfg Oct 2025 · Exp Mar 2027 | Medipol Pharmaceutical India Pvt. LtdHimachal Pradesh | Content of Folic acidOther | FDL, VadodaraState lab | Sep 2026 |
| Folic Acid Tablets IP 0.4 mg | Batch FO1TE011Mfg Oct 2024 · Exp Sep 2027 | Unicure India LtdUttarakhand | The sample does not conform to IP standards. It fails the Descriptive part for tablets as per IP, as specified in the Laboratory Protocol.Other | DTL, TVPMState lab | Sep 2026 |
| Folic Acid Tablets IP 0.4 mg | Batch FO1TE058Mfg Nov 2024 · Exp Oct 2027 | Unicure India LtdUttarakhand | The sample does not conform to IP standards. It fails the Descriptive part for tablets as per IP.Other | DTL, TVPMState lab | Sep 2026 |
| Folic Acid Tablets IP 0.4 mg | Batch FO1TE045Mfg Oct 2024 · Exp Sep 2027 | Unicure India LtdUttarakhand | The sample does not conform to the IP standards with respect to Description.Description | DTL, ThrissurState lab | Sep 2026 |
| Folic Acid Tablets IP 0.4 mg | Batch FO1TE064Mfg Nov 2024 · Exp Oct 2027 | Unicure India LtdUttarakhand | The sample does not conform to IP standards. It fails the 'Descriptive part' for tablets as per IP.Other | DTL, TVPMState lab | Sep 2026 |
| Folic Acid Tablets IP 0.4 mg | Batch FO1TE009Mfg Oct 2024 · Exp Sep 2027 | Unicure India LtdUttarakhand | The sample does not conform to IP standards. It fails the 'Descriptive part' for tablets as per IP, as specified in the Laboratory Protocol.Other | DTL TVPMState lab | Sep 2026 |
| Folic Acid Tablets IP 0.4 mg | Batch FO1TE010Mfg Oct 2024 · Exp Sep 2027 | Unicure India LtdUttarakhand | The sample does not conform to IP standards. It fails the 'Descriptive part' for tablets as per IP, as specified in the Laboratory Protocol.Other | DTL, TVPMState lab | Sep 2026 |
| Folic Acid Tablets IP 0.4 mg | Batch FO1TE050Mfg Oct 2024 · Exp Sep 2027 | Unicure India LtdUttarakhand | The sample does not conform to IP standards. It fails the 'Descriptive part' for tablets as per IP, as specified in the Laboratory Protocol.Other | DTL, TVPMState lab | Sep 2026 |
| Folic Acid Tablets IP 0.4 mg | Batch FO1TE022Mfg Oct 2024 · Exp Sep 2027 | Unicure India LtdUttarakhand | Sample does not conform to IP standards. This particular batch of sample fails in Descriptive part.Other | RDTL , ErnakulamState lab | Sep 2026 |
| Folic Acid Tablets IP 0.4 mg | Batch FO1TE067Mfg Nov 2024 · Exp Oct 2027 | Unicure India LtdUttarakhand | The sample does not conform to IP standards. It fails the 'Descriptive part' for tablets as per IP.Other | DTL, TVPMState lab | Sep 2026 |
| Folic Acid Tablets IP 0.4 mg | Batch FO1TE026Mfg Oct 2024 · Exp Sep 2027 | Unicure India LtdUttarakhand | The sample does not conform to IP standards. It fails the 'Descriptive part' for tablets as per IP.Other | DTL, TVPMState lab | Sep 2026 |
| Folic Acid Tablets IP 0.4 mg | Batch FO1TE016Mfg Oct 2024 · Exp Sep 2027 | Unicure India LtdUttarakhand | The sample does not conform to IP standards. It fails the 'Descriptive part' for tablets as per IP, as specified in the Laboratory Protocol.Other | DTL, TVPMState lab | Sep 2026 |
| Folic Acid Tablets IP 0.4 mg | Batch FO1TE065Mfg Nov 2024 · Exp Oct 2027 | Unicure India LtdUttarakhand | The sample does not conform to IP standards. If fails the tests'Assay' and 'Dissolution' as per IP, as specified in the Laboratory ProtocolAssay | DTL,TVPMState lab | Sep 2026 |
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.