busPIRone Hydrochloride Tablets 5 mg Recall: Subpotent
busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, Area, Meerut Road, Ghazibad…
What is the FDA recall status?
The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.
Why was busPIRone Hydrochloride Tablets 5 mg recalled?
Subpotent drug
What should I do if I have this product?
Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.
Full product description
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 29300-244-05.
Which lot codes, UPCs or models are affected?
Lot: ZBUL25001, Exp 12/31/2027
- Agency record number
- D-0511-2026
- Product
- busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, Area, Meerut Road, Ghazibad…
- Recalling firm
- Unichem Pharmaceuticals USA Inc.
- Quantity
- 10,875 Bottles
- Distribution
- USA Nationwide
- Recall started
- April 13, 2026
- Report date
- May 13, 2026
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (drug)