busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only

Unichem Pharmaceuticals USA Inc. has recalled busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on May 13, 2026 and was initiated on April 13, 2026. It is classified as a Class III recall, which means using this product is not likely to cause health problems, but it breaks an FDA rule (for example, a labeling or packaging issue).

Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.

What was recalled?

This recall covers busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, with approximately 10,875 Bottles affected. The company behind the recall is Unichem Pharmaceuticals USA Inc., based in East Brunswick, NJ. The FDA describes the product as: “busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, Area, Meerut Road, Ghazibad - 201 003, India Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ 08816, NDC 29300-244-0…”

Why was busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only recalled?

According to the FDA, the stated reason for the recall is: “Subpotent drug.” In plain terms, this recall relates to a potency or effectiveness issue.

This recall means the medicine may be stronger or weaker than its label says, or may not release its ingredient the way it should. That matters because too little medicine may not treat the condition, and too much can cause side effects. Anyone taking an affected product is generally advised to consult their pharmacist or doctor about a replacement.

What should you do?

If you think you may have bought busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, compare it against the product description and identifying codes (Lot: ZBUL25001, Exp 12/31/2027) before using it. This recall is currently listed as ongoing.

The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact Unichem Pharmaceuticals USA Inc. or your local health authority.

About this recall

This recall was distributed in NJ. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.