58 Drug Batches, Including Dexona Fail CDSCO Quality Standards
New Delhi: In its continued effort to ensure drug safety and compliance, the Central Drugs Standard Control Organisation (CDSCO) has flagged 58 batches of pharmaceutical products as Not of Standard Quality (NSQ) in its latest monthly alert for May 2025.
The list includes a range of commonly prescribed drugs, injectables, oral suspensions, and combination formulations from various manufacturers across India.
“As part of the continuous regulatory surveillance, drug samples are picked from sales/distribution point, analyzed and list of Not of Standard Quality (NSQ) drugs are displayed on CDSCO portal on monthly basis. The purpose of displaying the NSQ list is to make stakeholders aware about the NSQ batches identified in the market,” the apex drug regulatory body clarified in it's official notice.
The alert covers findings from Central and Regional Drug Testing Laboratories (CDL/CDTL/RDTL), including CDL Kolkata, RDTL Guwahati, RDTL Chandigarh, CDTL Mumbai, and CDTL Indore.
Among the drugs flagged for quality issues are CALXIA-500 (Calcium Carbonate + Vitamin D3) tablets by Gidsha Pharmaceuticals – flagged for dissolution failure (CDL Kolkata); Relatively common injectables like Ondansetron, Rabeprazole Sodium, Pantoprazole, Ciprofloxacin, and Betamethasone Sodium Phosphate – failed tests related to particulate matter, clarity, pH, or assay. Sitagliptin & Metformin FDC (Sitajak-M) by Jackson Laboratories – failed assay test for Sitagliptin. Buprenorphine and Buprenorphine Hydrochloride Injections – flagged for spurious identification, particulate matter, and related substances. Fexofenadine (Fexodil 180 mg) and Pantoprazole tablets – flagged for dissolution failures.
Significantly, a product from Zydus Healthcare Limited – Dexamethasone Sodium Phosphate Injection (Dexona) – was reported as NSQ due to, “Particulate matter, Assay of Dexamethasone Phosphate and Description.”
In addition to injectables and tablets, oral suspensions, jellies, syrups, and probiotics were also among those reported. Notably, Sporlac Tablets (Probiotics) manufactured by J.B. Chemicals & Pharmaceuticals Ltd. were flagged for failing the “Identification of Bacillus clausii” test.
Other NSQ findings included issues of sterility, microbial limits, uniformity of weight, assay content, and dissolution, all of which are critical parameters under the Drugs and Cosmetics Act, 1940. The CDSCO defines NSQ drugs as, “The drugs that fail to meet the quality standards or specifications are known as Not of Standard Quality (NSQ) drugs.”
NOT OF STANDARD QUALITY (NSQ) ALERT FOR THE MONTH OF MAY-2025 (CDSCO/Central Laboratories)
S.No | Product/Drug Name | Batch No. | Manufacturing Date | Expiry Date | Manufactured By | NSQ Result | Reported by CDSCO Laboratory |
1. | Calcium Carbonate 500 mg + VIT. D3 250 IU Tablets IP (CALXIA-500) | GTL1317 | 12/2024 | 11/2026 | M/s. Gidsha Pharmaceuticals, Plot No. 611, 612, Mega GIDC, Kharedi, Dahod 389151, Gujarat. | Dissolution (for Calcium) | CDL, Kolkata |
2. | Calcium Carbonate 500 mg + VIT. D3 250 IU Tablets IP (CALXIA-500) | GTL1295 | 12/2024 | 11/2026 | M/s. Gidsha Pharmaceuticals, Plot No. 611, 612, Mega GIDC, Kharedi, Dahod 389151, Gujarat. | Dissolution (for Calcium) | CDL, Kolkata |
3. | Calcium Carbonate 500 mg + VIT. D3 250 IU Tablets IP (CALXIA-500) | GTL1316 | 12/2024 | 11/2026 | M/s. Gidsha Pharmaceuticals, Plot No. 611, 612, Mega GIDC, Kharedi, Dahod 389151, Gujarat. | Dissolution (for Calcium) | CDL, Kolkata |
4. | Vitamin B Complex Injection 30 ml (WA-PLEX ) | 111 | 12/2024 | 05/2026 | M/s. Weismanna Health Care Pvt. Ltd., Plot No. 44 &45, Industrial Estate, Ongole523002 , Andhra Pradesh | Description and Particulate matter | CDL, Kolkata |
5. | Ondansetron Injection IP 2 mg/ml | ONA12515 | 01/2025 | 12/2026 | M/s. Nandani Medical Laboratories Pvt. Ltd., 221/5, Bicholi Hapsi, Kanadia Road, Indore. | Particulate matter | CDL, Kolkata |
6. | Rabeprazole Sodium Injection IP 20 mg/vial | MD23H27 | 08/2023 | 07/2025 | M/s. Martin & Brown Bio Sciences, K. No. 918/419, Malkumajra, Nalagarh Road, Baddi, Dist. Solan, (H.P.) 173205 | pH, Clarity of Solution, Particulate matter, Uniformity of Weight, Assay of Rabeprazole Sodium and Description. | CDL, Kolkata |
7. | Enzox Liquid Digestive Supplement | ES-24011/11 | 12/2024 | 05/2026 | M/s.Tidal Laboratories Pvt. Ltd. Patch-5, Phase-II Gowalthai, Distt. Bilaspur174201 (H.P.), INDIA | Assay/Content of Pepsin activity. | CDL, Kolkata |
8. | Ciprofloxacin Injection IP (0.2%w/v) (Ciprox) | 2250946 | 02/2025 | 01/2028 | M/s. Otsuka Pharmaceutical India Private Limited, Village- Vasana-Chacharwadi, Tal- | Particulate contamination. | CDL, Kolkata |
Sanand, Dist.-Ahmedabad382213, India | |||||||
9. | Dobutamine Hydrochloride Injection IP 5 ml | DBA12404 | 08/2024 | 07/2026 | M/s. Nandani Medical Laboratories Pvt. Ltd., 221/5, Bicholi Hapsi, Kanadia Road, Indore | Particulate matter and Description | CDL, Kolkata |
10. | Sitagliptin & Metformin Tablets 50 mg + 1000 mg (Sitajack-M ) | T-2916 | 09/2024 | 08/2026 | M/s. Jackson Laboratories Pvt. Ltd., 22-24, Majitha Road, Bye Pass, Amritsar-143001 (India) | Assay of Sitagliptin | CDL, Kolkata |
11. | Betamethasone Sodium Phosphate Injection IP (Betagin 1 ml) | P24L107 | 08/2024 | 07/2026 | M/s. Paksons Pharmaceuticals Private Limited, 36, Milestone, Delhi Rohtak Road, Sankhol, Bahadurgarh-124507, Haryana | Particulate matter, Assay of Betamethasone Sodium Phosphate and Description | CDL, Kolkata |
12. | Pantoprazole for Injection BP 40 mg | AA013026 | 06/2023 | 05/2025 | M/s. ANG Lifesciences India Ltd., Village: Kishanpura, Nalagarh Road, Tehsil: Baddi, Distt: Solan, HP-174101 | Clarity and Colour of Solution | CDL, Kolkata |
13. | Pantoprazole for Injection BP 40 mg | AA013047 | 09/2023 | 08/2025 | M/s. ANG Lifesciences India Ltd. Village Kishanpura, Nalagarh Road, Tehsil: Baddi, Distt. Solan, HP-174101 | Clarity and Colour of Solution | CDL, Kolkata |
14. | Sodium Chloride Injection U.S.P.(3% w/v ) (Hypertonic 3NS 100 ml) | G250146001 | 01/2025 | 12/2027 | M/s. Vision Parental Pvt. Ltd., A-2-44,45 Sector-15, GIDA Industrial Area, Gorakphur- 273209 (U.P.), India | Particulate Matter | CDL, Kolkata |
15. | Pantoprazole Tablets IP 40 mg | 0092 | 07/2024 | 06/2026 | M/s. Hindustan Antibiotics Ltd., Pimpri, Pune-411018, India. | Dissolution and Description | CDL, Kolkata |
16. | Fexofenadine Tablets IP (Fexodil 180 mg) | T-4029 | 01/2025 | 12/2026 | M/s. Jackson Laboratories Pvt. Ltd., 22-24, Majitha Road, Bye Pass, Amritsar-143001 (India) | Dissolution test after 10 min and after 30 min | CDL, Kolkata |
17. | Cefixime Tablets IP 200 mg | B240875 | 06/2024 | 05/2026 | M/s. Bochem Healthcare Pvt. Ltd. 83,84 Industrial Area, Dewas Road Nagziri, Ujjain 456010 (M.P.) India | Test of “Water” | CDL, Kolkata |
18. | Pantoprazole for Injection BP 40 mg | AA013043 | 08/2023 | 07/2025 | M/s. ANG Lifesciences India Ltd., Village: Kishanpura, Nalagarh Road, Tehsil: Baddi, Distt. Solan, HP-174101 | Clarity and colour of solution | CDL, Kolkata |
19. | Tranexamic Acid Tablets IP (Trenaxa 500 ) | 18242021A | 08/2024 | 07/2027 | M/s.Macleods Pharmaceuticals Ltd., Khasra No. 21,22,66,67 & 68, AhoYangtam, Namchepung, PO: Ranipool, Sikkim-737135 | Spurious Identification and Assay of Tranexamic Acid | CDL, Kolkata |
20. | Dexamethasone Sodium Phosphate Injection IP (Dexona) | N400726 | 06/2024 | 11/2025 | M/s. Zydus Healthcare Limited, At: PF 61 & 62, Sanand GIDC- II Industrial Estate, Tal: Sanand, Dist.: Ahmedabad382110, Gujarat, India | Particulate matter, Assay of Dexamethasone Phosphate and Description | CDL, Kolkata |
21. | Bupivacaine Hydrochloride in Dextrose Injection USP 4 ml | 17B24005 | 09/2024 | 08/2026 | M/s. Radiant Parenterals Ltd., 242/4, 5 & 6, G.I.D.C. Estate at & Post Waghodia, DistVadodara, Gujarat-391760 | pH, Bacterial Endotoxins Test, Particulate Matter in Injections and Description | CDL, Kolkata |
22. | Vitamin B-Complex with Vitamin C and Biotin Capsules (Vitabon ) | C-3465 | 11/2024 | 10/2026 | M/s. Jackson Laboratories Pvt. Ltd., 22-24, Majitha Road, Bye Pass, Amritsar-143001 (India). | Assay/content of Calcium Pantothenate | CDL, Kolkata |
23. | Rabeprazole Sodium (EC) & Domperidone (SR) Capsules (Dorsai) | DYC-24007 | 04/2024 | 03/2026 | M/s. DYCOTT Healthcare, Kh. No-341/1, Vill Dasomajra, P.O. Bhud, Baddi, Distt.-Solan (HP)-173205 | Dissolution of Rabeprazole Sodium (acid stage), Dissolution of Rabeprazole Sodium (buffer stage) and Assay of Rabeprazole Sodium | CDL, Kolkata |
24. | Buprenorphine Injection I.P. (Talgesic Injection) | BUP324002 | 06/2024 | 05/2026 | M/s. Indus Pharma Pvt. Ltd., A-181, RIICO, Ghiloth, Alwar, Rajasthan, 301705 (India) | Spurious Identification and Assay of Buprenorphine Hydrochloride, Particulate matter and Description | CDL, Kolkata |
25. | Buprenorphin Injection I.P. (Noophin Injection ) | LM18898 | 11/2022 | 10/2028 | M/s. Cooper Pharma Limited, C-3, Industrial Area, Selaqui, Dehradun-248197 (U.K.). | Related Substances, Particulate matter, Sterility , Assay of Buprenorphine Hydrochloride eq. to Buprenorphine and Description | CDL, Kolkata |
26. | Ondansertron Orally Disintegrating Tablets IP 4 mg (ONVIN-4 MD TABLETS ) | RV24012 | 05/2024 | 04/2026 | M/s. Rivpra Formulation Pvt. Ltd., Plot No. 8, Sector-6A, IIE SIDCUL, Haridwar-249403 (U.K.) | Related Substances | CDL, Kolkata |
27. | Aceclofenac & Paracetamol Tablets (Elzefen-P ) | PC24021 | 03/2024 | 02/2026 | M/s. Prochem Pharmaceuticals Pvt. Ltd., 140-141, Makkanpur, Bhagwanpur, Roorkee, Distt. Haridwar, Uttarakhand-247661 | Assay of Aceclofenac | CDL, Kolkata |
28. | Zinc Sulphate Dispersible Tablets IP 20 mg | LMT240804 | 07/2024 | 06/2026 | M/s. Life Max Cancer Laboratories, Plot No. 106 & 106 A, Sector6A, IIE, SIDCUL, Haridwar249403 (U.K) | Uniformity of Dispersion & Disintegration | RDTL, Guwahati |
29. | METRONIDAZOLE TABLETS IP (Martigyl400) | MT-24D03 | 04/2024 | 03/2026 | M/s.Martin & Brown Biosciences, K. No. 918/419, Malkumajra, Nalagarh Road, Baddi, Distt. Solan (H.P.)173205 | Dissolution | RDTL, Guwahati |
30. | Sodium Chloride Injection I.P. (0.9% w/v).. (NS) | 01BF2354 | 03/2024 | 02/2027 | M/s. Paschim Banga Pharmaceutical (A Unit Of FARISTA VANIJYA Pvt. Ltd.), NH-31, Tin Mile Hat, Sonapur Hat, P.S. Chopra, Dist:- Uttar Dinajpur, Pin 733 214 (W.B.) | Sterillity & Description | RDTL, Guwahati |
31. | Disposable Syringes (5ml) (SUI) | 4051124S11 | 11/2024 | 10/2027 | M/s Hindustan Ultra Care Limited, Village, Mandana, Jhalawar Road, NH-52, Kota (Rajasthan), India - 325003 | Sterillity | RDTL, Guwahati |
32. | Telmisartan Tablets IP 40mg | 251TTF025 | 12/2024 | 11/2027 | M/s. Swiss Garnier Life Sciences, 21-23, Industrial Area, Mehatpur, Dist. Una, Himachal Pradesh- 174 315. INDIA | Dissolution | RDTL, Guwahati |
33. | Telmisartan Tablets IP 40 mg | 251TTF036 | 12/2024 | 11/2026 | M/s. Swiss Garnier Life Sciences, 21-23, Industrial Area, Mehatpur, Dist. Una, Himachal Pradesh- 174 315. INDIA | Dissolution | RDTL, Guwahati |
34. | Dicyclomine Hydrochloride Tablets IP 10 mg | TK24-08 | 11/2024 | 10/2026 | M/s.Om Biomedic Pvt. Ltd..,, Plot No. 68, 69, 82 & 83, Sector - 6A, IIE, SIDCUL, Haridwar-249 403 (U.K.) | Description | RDTL, Guwahati |
35. | ALBENDAZOLE TABLETS I.P. | PGT24407 | 07/2024 | 06/2027 | M/s. Affy Parenterals, Vill,.Gullarwala, P.O.Baddi, Distt. Solan-173205 (HP) | Dissolution of Albendazole | RDTL, Chandigarh |
36. | Sildenafil citrate oral jelly 5 gm (King of jelly) | 25005 | 02/2025 | 01/2028 | M/s Banson Pharmaceuticals Pvt.Ltd., C-9, C10, Focal Point, Nabha-147201 | Description and Assay of Sildenafil Citrate | RDTL, Chandigarh |
37. | Ofloxacin Tablets IP 200 mg | DL-55 | 10/2024 | 09/2026 | M/s. DUTCH Formulations, 32, Industrial Area, Village Johron, Kala-Amb, Tehsil Nahan, District Sirmour, H.P.-17030 | Dissolution and Assay of Ofloxacin | RDTL, Chandigarh |
38. | Ofloxacin and Ornidazole Tablets IP 200 mg+500mg | DL-136 | 12/2024 | 11/2026 | M/s. DUTCH Formulations, 32, Industrial Area, Village Johron, | Uniformity of weight, Dissolution of Ornidazole, | RDTL, Chandigarh |
Kala-Amb, Tehsil Nahan, District Sirmour, H.P.-17030 | Dissolution of Ofloxacin and Assay of Ofloxacin and Ornidazole | ||||||
39. | Azithromycin Tablets IP 500 mg | DL-52 | 10/2024 | 09/2026 | M/s. DUTCH Formulations, 32, Industrial Area, Village Johron, Kala-Amb, Tehsil Nahan, District Sirmour, H.P.-17030 | Dissolution, Uniformity of weight and Assay of Azithromycin Dihydrate calculated as Azithromycin | RDTL, Chandigarh |
40. | Metronidazole Tablets IP 400 mg | B240578 | 05/2024 | 04/2027 | M/s.Bochem Healthcare Pvt. Limited, 83-84, Industrial Area, Dewas Road, Nagziri, Ujjain 45601-(M.P.) India | Dissolution | RDTL, Chandigarh |
41. | Amoxycillin and Potassium Clavulanate with Lactic Acid Bacillus Tablets (Polo-625 LB Tablets) | PL2406001 | 10/2024 | 11/2026 | M/s. Paradox Pharmaceuticals, Kachpura, Baddi, Nalagarh Road Tehsil Nalagarh Dist. Solan (HP)174103 | Identification and Assay of Amoxycillin Trihydrate, Potassium Clavulanate and Lactic Acid Bacillus | RDTL, Chandigarh |
42. | Azithromycin Tablets IP 250 mg (RICK-250 TABLETS) | Not mentioned | NM | NM | M/s. Paradox Pharmaceuticals, Kachpura, Baddi, Nalagarh Road Tehsil Nalagarh Dist. Solan (HP)174103 | Identification, Dissolution and Assay of Azithromycin Dihydrate Calculated as Anhydrous Azithromycin | RDTL, Chandigarh |
43. | Cefixime and Lactic Acid Bacillus Dispersible Tablets (Micoceff-LB 200 Tablets) | CFL2411001 | 11/2024 | 10/2026 | M/s. Maxcel Life Care, 302/304 A, Gitanjali Apartment Shanti Nagar, Mumbai (Thane)-53.) | Identification and Assay of Cefixime Trihydate and Lactic Acid Bacillus | RDTL, Chandigarh |
44. | Amoxycillin and Potassium Clavulanate Tablets IP (Rumentin-625 Tablets) | RUM241100 2 | 11/2024 | 10/2026 | M/s. Rextuse Pharmaceuticals, Ind. Area, Phase-I, Haridwar, Uttrakhand 249401 | Identification and Assay of Amoxycillin Trihydrate and Potassium Clavulanate and Dissolution of Amoxycillin Trihydrate and Potassium Clavulanate | RDTL, Chandigarh |
45. | Azithromycin Tablets IP 250 mg (RICK-250 TABLETS) | AZR2411010 | 01/2025 | 12/2026 | M/s. Paradox Pharmaceuticals, Kachpura, Baddi, Nalagarh Road Tehsil Nalagarh Dist. Solan (HP)174103 | Identification, Dissolution and the Assay of Azithromycin | RDTL, Chandigarh |
46. | Pantoprazole Gastro resistant &Domperidone prolonged release Capsules IP | PZD242206 | 01/2025 | 12/2026 | M/s. Paradox Pharmaceuticals, Kachpura, Baddi, Nalagarh Road Tehsil Nalagarh Dist. Solan (HP)174103 | Identification and Assay of Pantoprazole Sodium calculated as Pantoprazole and Domperidone and the Dissolution of Pantoprazole Sodium calculated as Pantoprazle. | RDTL, Chandigarh |
47. | Injection Oxytocin Vet. 100 ml Vial | Not mentioned | NM | NM | Not mentioned | pH and Sterility | RDTL, Chandigarh |
48. | Injection Oxytocin Vet. 50 ml Vial | Not mentioned | NM | NM | Not mentioned | pH and Sterility | RDTL, Chandigarh |
49. | Amoxycillin Trihydrate Capsules I.P. (Zymox-500 (Yellow)) | ZYMC-2407 | 04/2024 | 04/2026 | M/s. Laborate Pharmaceuticals India Ltd., 51, Indl. Area, Panta Sahib (H.P.) Manufatured for :gpp AZALADE (A division of Laborate Pharmaceuticals India Ltd), 101, KohandAssandh Road, V.P.O. Salwan, Haryana 132046. | "Assay/ content of Amoxycillin" | CDTL-Mumbai |
50. | SPORLAC Tablets (Tablets of Probiotics) | MS024004 | 04/2024 | 05/2026 | M/s.J.B. Chemicals & Pharmaceuticals Ltd., Plot No.25 & 26, Pharmacity, Selaqui, Dehradun, Uttarakhand. | "Identification of Bacillus clausii" | CDTL-Mumbai |
51. | Paracetamol 250 mg & Mefenamic Acid 100 mg Suspension, 60 ml (Pacimol MF 250 Suspension) | INC014022R | 04/2024 | 03/2026 | M/s.Ipca Laboratories Ltd., Sejavta, Ratlam 457 001 | "Assay of Paracetamol and Mefenamic Acid" | CDTL-Mumbai |
52. | Clopidogrel & Aspirin Tablets (75 mg/ 75 mg) | GT241288 | 07/2024 | 06/2026 | M/s. Theon Pharmaceuticals Ltd., Vill. Saini Majra, Tehsil Nalagarh, Distt. Solan (H.P.) 174 101. | "Description" | CDTL-Mumbai |
53. | MULTIPLE ELECTROLYTES AND DEXTROSE INJ. TYPE-1 I.P. (AROLYTE P) | 1227421S | 12/2024 | 11/2027 | M/s. Shree KrishnaKeshav Laboratories Ltd.,Amraiwadi Road, Ahmedabad- 380 008, | "Assay of Potassium" | CDTL-Mumbai |
54. | Haematinic Capsules (R.B. TONE) | D40652 | 11/2024 | 10/2026 | M/s. Medley Pharmaceuticals Ltd., Plot No. 18 & 19, Zari Causeway Road, Kachigam Daman, INDIA | "Microbial limit test (Total combined yeasts/molds count)" | CDTL-Mumbai |
55. | Aceclofenac Tablets I.P 100 mg | T4167 | 05/2024 | 04/2026 | M/s. Zest Pharama, 275, Sector "F" Sanwer Road, Indore - 452 015 | Description | CDTL- Indore |
56. | Paracetamol Tablet I.P 500 mg | KA1334 | 12/2023 | 11/2026 | M/s. Karnataka Antibiotics & Pharmaceuticals Limited, Plot No. 37, Site No. 34/4, NTTF Main Road, II Phase, Peenyas Industrial Area, Bengaluru560058, India | Description | CDTL- Indore |
57. | Betahistine Dihydrochloride Tablet I.P (CGHEST-8) | CT24250284 A | 05/2024 | 04/2026 | M/s. CMG Biotech Pvt. Ltd (Unit II), Plot No. 58, Phase III, Industrial Area, Sansarpur Terrace, H.P - 176501 | Description | CDTL- Indore |
58. | Sucralfate Oral Suspension (AXID 200) | 624-470 | 06/2024 | 05/2026 | M/s.Zee Laboratories Ltd., 47, Industrial Area, Paonta, Sahib - 173 025 | The sample does not conform to claim standards with respect to Description | CDTL- Chennai |
Not of Standard Quality (NSQ) drugs:
The drugs that fail to meet the quality standards or specifications are known as Not of Standard Quality (NSQ) drugs.
(Further, the term ‘standards of quality’ is defined under the Section 16 (1) (a) of Drugs & Cosmetics Act, 1940, that the ‘standards of quality’ mean that the drug complies with the standards set out in the Second Schedule of the said Act.)
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