Health and Me

Ishita Roy

Glenmark Recalls Birth Control Pills In US Over Manufacturing Issues

Glenmark, a leading Indian drugmaker, has recalled its products in the US over manufacturing issue, confirmed the US Food and Drug Administration (USFDA). 

The USFDA released an Enforcement Report, which noted that the US-based unit of Glenmark Pharmaceuticals in recalling 26,928 packs of oral contraceptive medicines in the US. The company's unit based in Mahwah, New Jersey, has now recalled the affected lot of the following birth control pills:

<ul><li>Viorele</li><li>Desogestrel</li><li>Ehinyl Estradiol</li></ul>

The report also noted that Ethinyl Estradiol tablets were recalled due to "failed impurities and degradation specifications". The affected drugs were produced in the company's Mumbai headquarters' Goa manufacturing facility. This is because India has the highest number of USFDA-compliant pharmaceutical plants outside of the US. 

The drug firm also issued a notice for Class II nationwide recall on September 3, 2025. 

The USFDA notes that recalls are actions taken by the firm to remove and product from the market and could be conducted by company's own initiative, or by the FDA request or order. 

Class II recall means a situation in which the use of or the exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequence is remote. 

<h2>What Are The Different Categories Of Recalls?</h2>

As per the USFDA, there are 5 different categories of recalls, namely:

<ul><li>Class I Recall</li><li>Class II Recall</li><li>Class II Recall</li><li>Market Withdrawal</li><li>Medical Device Safety Alert</li></ul>

<ul><li><strong>Class I recall: </strong>a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.</li></ul>

<ul><li><strong>Class II recall: </strong>a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.</li></ul>

<ul><li><strong>Class III recall:</strong> a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.</li></ul>

<ul><li><strong>Market withdrawal: </strong>occurs when a product has a minor violation that would not be subject to FDA legal action. The firm removes the product from the market or corrects the violation. For example, a product removed from the market due to tampering, without evidence of manufacturing or distribution problems, would be a market withdrawal.</li></ul>

<ul><li><strong>Medical device safety alert: </strong>issued in situations where a medical device may present an unreasonable risk of substantial harm. In some case, these situations also are considered recalls.</li></ul>

<h2>Are There Any Other Drugs Being Recalled?</h2>

Dr Reddy's Laboratories, another major Indian drugmaker, has also recalled its muscle relaxant in the US. The company's Princeton, New Jersey-based subsidiary has recalled 571 vials of Succinylcholine Chloride Injection. The recall was initiated due to "out-of-specification results during the 6-month stability testing," according to USFDA.

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Glenmark, a leading Indian drugmaker, has recalled its products in the US over manufacturing issue, confirmed the US Food and Drug Administration (USFDA). What Did The USFDA Say?The USFDA released an Enforcement Report, which noted that the US-based unit of Glenmark Pharmaceuticals in recalling 26,928 packs of oral contraceptive medicines in the US. The company's unit based in Mahwah, New Jersey, has now recalled the affected lot of the following birth control pills:VioreleDesogestrelEhinyl EstradiolThe report also noted that Ethinyl Estradiol tablets were recalled due to "failed impurities and degradation specifications". The affected drugs were produced in the company's Mumbai headquarters' Goa manufacturing facility. This is because India has the highest number of USFDA-compliant pharmaceutical plants outside of the US. The drug firm also issued a notice for Class II nationwide recall on September 3, 2025. What Does Class II Recall Mean?The USFDA notes that recalls are actions taken by the firm to remove and product from the market and could be conducted by company's own initiative, or by the FDA request or order. Class II recall means a situation in which the use of or the exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequence is remote. What Are The Different Categories Of Recalls?As per the USFDA, there are 5 different categories of recalls, namely:Class I RecallClass II RecallClass II RecallMarket WithdrawalMedical Device Safety AlertClass I recall: a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.Class II recall: a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.Class III recall: a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.Market withdrawal: occurs when a product has a minor violation that would not be subject to FDA legal action. The firm removes the product from the market or corrects the violation. For example, a product removed from the market due to tampering, without evidence of manufacturing or distribution problems, would be a market withdrawal.Medical device safety alert: issued in situations where a medical device may present an unreasonable risk of substantial harm. In some case, these situations also are considered recalls.Are There Any Other Drugs Being Recalled?Dr Reddy's Laboratories, another major Indian drugmaker, has also recalled its muscle relaxant in the US. The company's Princeton, New Jersey-based subsidiary has recalled 571 vials of Succinylcholine Chloride Injection. The recall was initiated due to "out-of-specification results during the 6-month stability testing," according to USFDA.