Heaps of a copycat erectile dysfunction med are flying off U.S. shelves, though not for the reason manufacturer Sun Pharmaceutical Industries might hope.
India's Sun Pharma is recalling more than 100,000 bottles in the U.S. of its generic tadalafil tablet for erectile dysfunction (ED), because the "incorrect grade" of an inactive ingredient was added during production, The Economic Times reports, citing the U.S. FDA's latest enforcement report.
The lots in question were produced by Sun Pharma in India and shipped out to a single U.S. distributor that "may" have further released the product in the U.S., the FDA said.
The recall, which kicked off Oct. 25, 2021, covers 30-count bottles of both 5-mg and 20-mg doses, a generic version of Eli Lilly's well-known ED medication Cialis.
The bottles were pulled due to faulty product formulation, the FDA explained. Specifically, an "incorrect grade" of crospovidone was used to make the drug. Crospovidone is an inactive ingredient that's often added to drug formulations to aid absorption of the active med, Drugs.com says.
In all, the product pull will affect 36,786 bottles of the 20-mg tablet, plus 73,957 bottles of the 5-mg version, the FDA says in its report.
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The bottles of 20-mg tadalafil carried an expiration date of April 2023, while the 5-mg tablets were meant to be good until May of that same year.
The enforcement report didn't cover the potential risks of taking the tainted med, nor did it mention any side effect reports linked to the recall.
Shortly before it started yanking its ED med, Sun Pharma in October initiated a recall on 22,752 blister packs of its extended-release loratadine-D tablets, according to an earlier FDA report. The rhinitis and cold medicine was pulled because of "failed moisture limits," the regulator said.