Last Updated on April 9, 2025 by The Health Master
Drug Recall
Bengaluru-based pharmaceutical company Strides Pharma Science has started a voluntary drug recall of over 440,000 cartons of its Testosterone Gel in the United States.
The drug recall, which commenced on March 5, 2025, has been officially documented by the US Food and Drug Administration (USFDA), raising concerns among patients and healthcare providers.
Affected Products and Quantities
According to the USFDA report, the drug recall encompasses two specific presentations of Testosterone Gel (1%):
- 195,952 cartons of the 2.5-gram quantity.
- 244,412 cartons of the 5-gram quantity.
It is crucial to note that this drug recall is specifically limited to products manufactured by the Chestnut Ridge, NY-based facility of Strides Pharma Inc.
What is Testosterone Gel 1%?
Testosterone Gel 1% is a prescription drug used for androgen replacement therapy.
It is prescribed for adults who have been diagnosed with conditions with deficiency or complete absence of endogenous testosterone.
These conditions are:
Primary Hypogonadism:
A condition where the testicles are unable to produce sufficient testosterone.
Hypogonadotropic Hypogonadism:
A condition where the pituitary gland or hypothalamus does not send a signal to the testicles to produce the required testosterone.
What is a Class II Drug Recall?
A Class II drug recall highlights a condition where the use or exposure of a defective product may cause temporary or medically reversible adverse health issues.
Details of the Affected Lots
Information from the HMP Global Learning Network report provides specific details regarding the recalled lots:
The 2.5-gram product sachets (NDC 64380-151-02) were distributed in cartons, with each carton containing 30 individual sachets.
A total of 244,412 cartons of the 5-gram product (NDC 64380-152-02) are part of this drug recall.
The expiry dates for the recalled batches are from March 2025 to January 2027.
The Reason Behind the Drug Recall:
The main reason behind this drug recall, started by Strides Pharma on March 5, 2025, is the concern about benzene exposure.
Benzene is a known human carcinogen, and its exposure may cause many health issues, which include:
- Blood disorders
- Cancers
Standard drug recall procedures:
Standard drug recall procedure must adhere to well-defined protocols for returning the recalled drugs to ensure the safeguard if public health.
Q: What should I do if I have a recalled drug of Testosterone Gel?
A: Immediately contact your pharmacy or healthcare provider. They will guide you on how to return the affected drug. Also consult your doctor for the replacement of the drug.
Q: What are the risks of benzene exposure?
A: Benzene is a known human carcinogen, and its exposure may cause many health issues, which include blood disorders and cancers.
Q: What is the USFDA doing about this drug recall?
A: The USFDA has classified this as a Class II drug recall and has registered it in its database (Event ID 96412). They are monitoring the situation to ensure the recalled products are removed from the market.
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
Disclaimer: The information we have provided is for general knowledge and for informational purpose only and it cannot be treated as medical advice. Always consult your doctor for any health issues and / or for the treatment of the same. The Health Master does not claim responsibility for this information.
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