Articles related to PRODUCT RECALL

Breckenridge Pharmaceutical initiated a voluntary Class II recall of duloxetine delayed-release capsules 60 mg (Lot 241069C, expiration May 31, 2027) on April 21, 2026, following detection of elevated N-nitroso-duloxetine impurity levels attributed to CGMP deviations at the Barcelona manufacturing site, affecting 165,761 bottles distributed nationwide.

Viatris recalled one lot of Xanax XR 3-mg extended-release tablets after failed dissolution testing, with the FDA classifying the action as Class II and reporting no adverse events to date.

A nationwide recall of more than 3 million OTC eye drops due to sterility concerns highlights the importance of routine patient counseling around non‑prescription ocular products.

The FDA notice added that a letter was sent out about the recall. However, it did not include a press release or other specific details.

“Emerging data from this confirmatory study have highlighted a safety profile that is unfavorable compared to that previously observed in clinical evaluation.” — Christelle Huguet, PhD, Ipsen

“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.” — FDA Class II Recall Definition