Last Updated on August 11, 2025 by The Health Master
Drug recall
The US Food and Drug Administration (USFDA) has once again highlighted drug recall due to important manufacturing and quality control issues within the pharmaceutical industry, with the following three Indian Pharma units:
These pharma units have started the drug recall of their drugs in the American market.
These drug recalls were initiated due to various manufacturing discrepancies and alarming product mix-ups.
Drug recall by Sun Pharma:
Sun Pharmaceutical Industries, a global pharmaceutical company headquartered in Mumbai, has currently initiated a drug recall, i.e., 448 bottles of its generic Lisdexamfetamine Dimesylate capsules.
The drug recall, initiated by Princeton-based Sun Pharmaceutical Industries Inc. on June 16, 2025, falls under a Class II drug recall due to “Failed Dissolution Specifications.”
Drug recall by Lupin:
Another Indian pharmaceutical company, Lupin, headquartered in Mumbai, has initiated a drug recall, i.e., 58,968 bottles of its generic combination drug, Lisinopril and Hydrochlorothiazide tablets.
The Class II drug recall, initiated by Naples-based Lupin Pharmaceuticals Inc., on June 20, 2025, due to the issue “Product Mix Up.”
The USFDA’s report reveals a sealed bottle of Lisinopril and Hydrochlorothiazide tablets (20mg/12.5mg) was found to contain a foreign tablet identified as an Atazanavir and Ritonavir tablet (300mg/100mg).
Drug recall by Dr. Reddy’s Laboratories:
Dr. Reddy’s Laboratories is also conducting a recall of 1,476 bottles of its Omeprazole Delayed-Release capsules.
This drug is commonly prescribed to treat various stomach and esophagus problems, including acid reflux and ulcers.
Princeton-based Dr. Reddy’s Laboratories, Inc. started this Class II drug recall on June 30, 2025.
The reason for this drug recall is the “presence of foreign tablets/capsules” within the Omeprazole bottles.
Divalproex Sodium extended-release 250 mg tablets were found mixed in with the Omeprazole capsules.
Q: What are Class I, II, and III drug recalls?
Class 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.
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.
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