By: Akanksha
Dr. Ram Manohar Hospital (RML), Delhi, has issued an urgent recall for 10 batches of medicines soon after they were labelled “Not of Standard Quality” following four separate notices released between September 7 and September 14.
The oral medications included Sodium Valproate 200 mg, Spironolactone 50 mg, and Imipramine 25 mg, as well as injections of Adenosine, Methyl Ergometrine, Multivitamins, Pheniramine Maleate, and Ascorbic Acid. These medicines are prescribed for various critical treatments, such as, heart conditions, seizure disorders, depression, and postpartum complications.
The administration has ordered all departments and wards to immediately stop the use of these stocks and return them to the assigned drug units.
Of the ten medications, eight were found to be of substandard quality after routine inspections, while tablets of Isosorbide Mononitrate 20 mg and Metoprolol 50 mg were found in powdered form inside the strips. Both batches were manufactured by Glowsun India Labs Private Limited.
| S. No. | Name of Medication | Prescribed in | Batch Number | Manufacturer | Recall Reason |
|---|---|---|---|---|---|
| 1 | Sodium Valproate Gastro-resistant 200mg | Epilepsy and Seizure Disorders | Affected Sept 14 lot | Contract Vendors (Including Jackson Laboratory Pvt. Ltd.) | Failed Analytical Testing (NSQ) |
| 2 | Spironolactone 50 mg | Heart failure, hypertension, fluid retention (edema) | Affected Sept 14 lot | Contract Vendors (Including Jackson Laboratory Pvt. Ltd.) | Failed Analytical Testing (NSQ) |
| 3 | Imipramine 25 mg | Symptoms of depression and to manage nighttime bedwetting in children | Affected Sept 14 lot | Contract Vendors (Including Jackson Laboratory Pvt. Ltd.) | Failed Analytical Testing (NSQ) |
| 4 | Metoprolol 50 mg | Hypertension, Angina, heart failure | ABT6608 | Glowsun India Labs Pvt. Ltd. | Physical defect (crumbled to powder) - notice issued on Sept 7 |
| 5 | Isosorbide Mononitrate 20 mg | Angina pectoris, coronary artery disease | ABT6711, Date of Manufacture July 2026 | Glowsun India Labs Pvt. Ltd. | Physical defect (crumbled to powder) - notice issued on Sept 9 |
On September 14, RML’s oral and topical drug unit marked three of the five tablet batches as having failed analytical testing, leading to their recall. Later, five batches of injectable medications also failed analytical testing and were labeled as “Not of Standard Quality” (NSQ).
| S. No. | Name of Medication | Prescribed in | Batch Number | Manufacturer | Recall Reason |
|---|---|---|---|---|---|
| 1 | Adenosine | Stable, regular, narrow-complex supraventricular tachycardia (SVT) | Affected Sept 14 lot | Contract vendor | Failed Analytical Testing (NSQ) |
| 2 | Methyl ergometrine | Excessive bleeding from the uterus after childbirth or an abortion | Affected Sept 14 lot | Contract vendor | Failed Analytical Testing (NSQ) |
| 3 | Multivitamin Injection | Severe vitamin deficiencies when oral supplements are insufficient | Affected Sept 14 lot | Contract vendor | Failed Analytical Testing (NSQ) |
| 4 | Pheniramine Maleate | Allergic conditions, motion sickness, and cold or flu symptoms | Affected Sept 14 lot | Contract vendor | Failed Analytical Testing (NSQ) |
| 5 | Ascorbic acid | Prevention and treatment of vitamin C deficiency and scurvy. | Affected Sept 14 lot | Contract vendor | Failed Analytical Testing (NSQ) |
In July 2026, the Delhi Drug Control Department seized and sealed approximately 2,675 vials of Oxytocin from RML Hospital, following sample collection in June. The affected batch was manufactured by Jackson Laboratories Private Limited, Amritsar. Oxytocin is a critical hormone used to induce labor and control excessive bleeding (postpartum hemorrhage) after childbirth.
Also Read : Rajasthan Bans Oxytocin Amid Probe Into 5 Maternal Deaths in Kota as Tests Find Missing Active Ingredient
In a report by the Times of India, the hospital administration stated: “The hospital initiated the recall process and issued recall letters for the identified medicines. All relevant units were advised to immediately stop using affected medicines and report any patient-related adverse events, if observed,”.
Officials added that no adverse reactions or alarming health effects have been reported by patients in relation to the affected medications.
“The hospital has made interim arrangements to ensure the availability of alternative medicines and avoid any disruption in patient care. The situation is being closely monitored, and all necessary measures are being taken in accordance with established drug quality and patient-safety protocols,” an RML official told The Times of India.
According to the official notices, all defective drugs from the affected batches were directed to be returned by clinical departments by September 18, whereas the powdered and substandard tablets were required to be sent back within three days of the respective notice being issued.
To prevent lapses in patient care, the hospital has arranged alternative medications to ensure that treatment cycles for chronic and acute conditions remain uninterrupted.
Substandard drugs can have serious consequences for patient health, including treatment failure, accelerated disease progression, antimicrobial resistance, and even fatal outcomes.
Poor quality drugs may contain toxic contaminants or incorrect dosage of active ingredients that can prove fatal.
They can also trigger reactions, such as, rashes, hives, other health risks, that can further increase the overall healthcare cost.
Also Read : UK Child’s Suspected Brain Tumor Revealed as Vitamin D Toxicity from Defective Supplement Batch
Do not discontinue an essential prescription medicine without consulting a healthcare provider.
Contact your prescribing physician if you suspect that you have a recalled batch.
Seek emergency medical care for serious symptoms, such as difficulty in breathing, swelling, severe allergic reactions, loss of consciousness or seizures.
This incident has raised questions about why the hospital’s drug quality surveillance framework is not being strengthened.
It is critical to identify defects at the batch level before the medication is prescribed to patients.
Quality control protocols must be significantly more rigorous, especially, for life-saving and crucial therapies.
(Rh/APC/MSM)