Health and Me

Ishita Roy

Nearly 90,000 Bottles Of Children's Ibuprofen Recalled As Foreign Particles Were Found

FDA recall

Nearly 90,000 bottles of children's ibuprofen have been recalled nationwide after complaints were made that the medication could contain a foreign substance. The federal health officials complained about the foreign substance due to which Strides Pharma Inc., headquartered in India recalled about 89,592 bottles of Children's Ibuprofen Oral Suspension, noted the US Food and Drug Administration. 

The recall happened after reports of a gel-like mass and black particles were found in the products. 

<h2>FDA Issues Class II Recall Against Children's Ibuprofen</h2>

The FDA has issued a Class II recall, which means the use of the affection medication could cause temporary or medically reversible health problems. It also translates to serious harm being considered remote. 

FDA has three categories for recall, Class I, Class II, and Class II. Class I recalls usually mean high risk. This could mean that defective products could cause serious health problems or death. Class II is for moderate risk, which has been issued for children's ibuprofen. Class III is for products with low risk. This is for products that are unlikely to cause any adverse health consequence, but they violate FDA labeling or manufacturing regulations.

Read: <a href="https://www.healthandme.com/nutrition/e-coli-outbreak-linked-to-cheddar-cheese-7-people-in-3-states-affected-article-153860339" data-type="tilCustomLink">E. Coli Outbreak Linked To Cheddar Cheese, 7 People In 3 States Affected</a> 

<h2>India-based Pharmaceutical Company Recalls Nearly 90,000 Bottles Of Ibuprofen</h2>

The India headquartered company Strides Pharma was manufacturing the product for Taro Pharmaceuticals USA Inc. and the products were distributed across the United States. 

The recalled medication is for the 100-milligram per 5-milliliter oral suspension sold in 4-fluid-ounce bottles. The affected lot numbers are 7261973A and 7261974A, with an expiration date of Jan. 31, 2027. The recall number is D-0390-2026.

Health officials have advised consumers who have the recalled ibuprofen to stop using it. The FDA however has not yet received reports of serious adverse health effects related to the recalls. 

<h2>Previous Cases Where Indian Drugmakers Distributing To US Recalled Their Products </h2>

Certain products were recalled from the US market due to manufacturing relayed issues. These products were by Indian drugmakers Sun Pharmaceutical Industries and Cipla. In an Enforcement Report by the FDA, it noted that the US-based arm of Mumbai-headquartered Sun Pharma has recalled more than 26,000 bottles of generic medicine used to treat dandruff and skin conditions that cause inflammation and itching. Sun Pharma, based in Princeton, New Jersey, recalled 24,624 bottles of Fluocinolone Acetonide Topical Solution after the product failed to meet impurity and degradation standards. The company also initiated Class III recall in US on December 30, 2025. 

Cipla recalled over 15,000 syringes from the US market. Headquartered in Warren, New Jersey, the company recalled 15,221 pre-filled syringes of Lanreotide Injection due to the presence of particulate matter. Cipla also initiated a recall of Class II on January 2 of this year.

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Nearly 90,000 bottles of children's ibuprofen have been recalled nationwide after complaints were made that the medication could contain a foreign substance. The federal health officials complained about the foreign substance due to which Strides Pharma Inc., headquartered in India recalled about 89,592 bottles of Children's Ibuprofen Oral Suspension, noted the US Food and Drug Administration. The recall happened after reports of a gel-like mass and black particles were found in the products. FDA Issues Class II Recall Against Children's IbuprofenThe FDA has issued a Class II recall, which means the use of the affection medication could cause temporary or medically reversible health problems. It also translates to serious harm being considered remote. FDA has three categories for recall, Class I, Class II, and Class II. Class I recalls usually mean high risk. This could mean that defective products could cause serious health problems or death. Class II is for moderate risk, which has been issued for children's ibuprofen. Class III is for products with low risk. This is for products that are unlikely to cause any adverse health consequence, but they violate FDA labeling or manufacturing regulations.Read: E. Coli Outbreak Linked To Cheddar Cheese, 7 People In 3 States Affected India-based Pharmaceutical Company Recalls Nearly 90,000 Bottles Of IbuprofenThe India headquartered company Strides Pharma was manufacturing the product for Taro Pharmaceuticals USA Inc. and the products were distributed across the United States. The recalled medication is for the 100-milligram per 5-milliliter oral suspension sold in 4-fluid-ounce bottles. The affected lot numbers are 7261973A and 7261974A, with an expiration date of Jan. 31, 2027. The recall number is D-0390-2026.Health officials have advised consumers who have the recalled ibuprofen to stop using it. The FDA however has not yet received reports of serious adverse health effects related to the recalls. Previous Cases Where Indian Drugmakers Distributing To US Recalled Their Products Certain products were recalled from the US market due to manufacturing relayed issues. These products were by Indian drugmakers Sun Pharmaceutical Industries and Cipla. In an Enforcement Report by the FDA, it noted that the US-based arm of Mumbai-headquartered Sun Pharma has recalled more than 26,000 bottles of generic medicine used to treat dandruff and skin conditions that cause inflammation and itching. Sun Pharma, based in Princeton, New Jersey, recalled 24,624 bottles of Fluocinolone Acetonide Topical Solution after the product failed to meet impurity and degradation standards. The company also initiated Class III recall in US on December 30, 2025. Cipla recalled over 15,000 syringes from the US market. Headquartered in Warren, New Jersey, the company recalled 15,221 pre-filled syringes of Lanreotide Injection due to the presence of particulate matter. Cipla also initiated a recall of Class II on January 2 of this year.