FDA recall, , Low risk
Unichem busPIRone Hydrochloride Tablets
BusPIRone Hydrochloride Tablets are subpotent.
Summary by Recall Canary from the FDA notice
What happened
Unichem Pharmaceuticals USA Inc., of East Brunswick, New Jersey, is recalling busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottles, because the drug is subpotent. The product, manufactured by Unichem Laboratories LTD. in India and distributed nationwide, was recalled beginning April 13, 2026, and added to the FDA's Enforcement Report on May 1, 2026.
The recall covers 10,875 bottles of the prescription tablets, which are manufactured for Unichem Pharmaceuticals (USA), Inc.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is your bottle affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle
- NDC
- 29300-244-05
- Lot code
- ZBUL25001
Recall details
- Company began the recall
- Sold in
USA Nationwide
- Company
- Unichem Pharmaceuticals USA Inc.East Brunswick, New Jersey
- Hazard
- Wrong drug strength
- Risk
Low risk
Taking it is unlikely to cause health problems.
FDA Class III recall · How risk is rated
- Event ID
- 98728
- Recall number
- D-0511-2026
- Quantity recalled
- 10,875 Bottles
All recalls from Unichem Pharmaceuticals USA Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
