Drug manufacturers Sun Pharma, Dr Reddy’s, and Aurobindo Pharma are recalling their products in the United States of America market due to manufacturing issues, according to a recent Enforcement Report from the US Food and Drug Administration (USFDA).

Dr Reddy’s Laboratories, Inc., based in Princeton, New Jersey-based is recalling Javygtor (sapropterin dihydrochloride) Powder for Oral Solution (100 mg) after it was categorized by the USFDA as a “Sub-potent Drug.”. The major pharmaceutical company is also recalling a lot of sapropterin dihydrochloride for similar reasons. The US regulatory said that the drug maker had initiated a Class 1 recall in the US on 8 April 2025.

Sun Pharma is recalling 11,016 vials of injectable amphotericin B liposome, which is used to treat fungal infections, from the US market, the USFDA announced. A Class II recall was initiated by the company’s US branch on 19 April, according to the USFDA, since the product was “Out of specification for assay.”

Moreover, Aurobindo Pharma is recalling 13,605 bottles of clorazepate dipotassium tablets, which come in 3.75 mg and 7.5 mg doses and are intended to treat anxiety, from the American market. A recall of the affected lot has been announced by the USFDA due to “Discoloration: Dotted and yellow spots on tablets.” The company initiated the Class II recall on 24 April of this year.

A different pharmaceutical company, FDC Ltd, has announced that it is recalling 3,82,104 units of Timolol Maleate Ophthalmic Solution, which is used to treat glaucoma, from the American market due to a “Defective Container,” according to the USFDA.

According to the USFDA, when use of or exposure to a violative product may result in short-term, medically reversible adverse health effects, or when the likelihood of major adverse health consequences is low, a Class II recall is triggered. The largest market for pharmaceutical products is the US, where the generic medication market is expected to be valued at approximately USD 115.2 billion in 2019.