Last Updated on November 26, 2025 by The Health Master
Drug recall
Drug recall: Glenmark recalls hundreds of thousands of packets of oral contraceptives manufactured in error but are a part of the drug supply chain in the United States.
An important warning has been issued to the consuming public regarding a popular oral contraceptive in the United States.
Drug manufacturer Glenmark Pharmaceuticals is in the process of actively recalling hundreds of thousands of packets of its birth control from the U.S. market due to a manufacturing error on a critical scale assessed by the U.S. Food and Drug Administration (USFDA).
This brings awareness to the quality control mechanisms of the international drug supply industry.
What’s Behind the Drug Recall
The Glenmark Pharmaceuticals Inc., USA branch (Mahwah, New Jersey) has issued a drug recall of 26,928 packets of its combination oral contraceptive brand Viorele (Desogestrel and Ethinyl Estradiol Tablets).
According to the FDA’s official recall, the reasoning for drug recall is failed impurities/degradation specifications.
In layman’s terms, the medication is not up to standard based on purity levels, meaning it degraded too much or had impurities that were above acceptable levels. This lot was manufactured at Glenmark’s Goa, India facility.
This is a national drug recall, classified as a Class II drug recall, which was implemented on September 3, 2025.
What Does Class II Drug Recall Mean?
When a drug is recalled, the USFDA classifies it to give consumers and healthcare providers a better understanding of the implications of this action.
Class II Recall: A drug has major violations, but exposure/use may cause temporary adverse health consequences or medically reversible consequences or the likelihood of serious adverse health consequences is remote.
Since this is an oral contraceptive, if the degradation causes reduced strength and could potentially prevent pregnancy (which would not be wanted), it could lead to medically irreversible complications.
Still, in summary, most people believe that this type of scenario is not common enough to concern themselves with unless they were seeking to become pregnant after years of using oral contraceptives.
Class II drug recall allow the general public to make risk assessments without panic since the health hazards are not severe enough to warrant a mass evacuation. Instead, the concerns are about validity and consistency of treatment options and how new/now ineffective lots will be re-distributed.
The Drug Supply Chain: India’s Role
It’s important to note that the international drug supply industry is interconnected globally, and India possesses the highest volume of pharmaceutical plants compliant with USFDA inspections outside of the United States.
This means that A LOT of generic/drug options flow from Indian facilities to stateside pharmacies.
Therefore, any manufacturing issues in India directly reflect on those drugs available in U.S. pharmacies and their consumers; when something’s off at Glenmark’s facility, Glenmark’s consumers in America feel it too.
What Consumers Should Know
If you’re a person who may be using Viorele or a generic version, here are some points to keep in mind about what drug recall means.
- Check lot numbers: If you have Viorele at home, check the name, lot number, and expiration date with anything your pharmacy/doctor tells you. If you’re unsure, consult your pharmacist.
- Do not stop taking it: Never stop taking any prescription without a doctor’s recommendation especially a hormone-based pill. Your pharmacist can guide you on what steps to take to proceed with either an unaffected lot or a non-brand therapeutic alternative.
- Pharmacies need to act: Pharmacies/wholesalers are accountable for pulling packets from their shelves through recall efforts.
Q: Should I stop taking my Viorele or generic if I have a pack?
A: Do not stop immediately without medical advice. Contact your pharmacist or doctor first. They will assist with checking lot numbers/advise on how to get another packet from a non-recalled batch or an equivalent option. Stopping hormonal birth control immediately can result in spotting and other symptoms.
Q: What does “failed impurities/degradation specifications” mean?
A: Quality control testing showed that either the medicine degraded too much (degradation) or that there was an unacceptable level of impurities as chemical byproducts (impurities). In other words, Viorele or the generic was essentially bad and may have been broken down too much or still contained birth control properties but had too much damage for consumers to safely use them. For an oral contraceptive, this means that this option would not work for preventative purposes.
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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