Lower riskDrug recall · FDA · Published April 13, 2026
Unichem busPIRone 5mg Tablets Recall: Subpotent Drug Risk
Unichem Pharmaceuticals recalls 500-count busPIRone Hydrochloride Tablets (5mg) due to subpotent drug content. This may result in ineffective treatment for patients requiring precise dosing. No remedy specified in official notice.
📍Recalling firmUnichem Pharmaceuticals USA Inc.1 Tower Center Blvd Ste 2200 · East Brunswick, NJ 08816-1145
✎ GovInfoNow plain-language explainer
Unichem Pharmaceuticals is recalling 500-count busPIRone Hydrochloride Tablets (5mg) because they may not contain enough active ingredient to be effective. This could lead to improper treatment outcomes for patients using the medication as prescribed. Read more at govinfonow.com/recall/31349-unichem-buspirone-5mg-tablets-recall-subpotent-drug-risk.
“Unichem busPIRone 5mg Tablets Recall: Subpotent Drug Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31349-unichem-buspirone-5mg-tablets-recall-subpotent-drug-risk. Based on FDA recall #D-0511-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0511-2026%22&limit=1).
The FDA announced on April 13, 2026, that Unichem Pharmaceuticals USA Inc. is recalling busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottles due to subpotent drug risks. The recall covers 10,875 bottles distributed nationwide.
The recalled busPIRone Hydrochloride Tablets are classified as a subpotent drug. The FDA has not reported specific incidents or injuries associated with this recall in the provided record.
Context
GovInfoNow's records show Unichem Pharmaceuticals USA Inc. has 11 other recalls on record since July 30, 2015. Recent similar recalls include a Jan. 21, 2026, recall for Doxazosin 4mg Tablets due to wrong ID imprint and a Jan. 21, 2026, recall for Bisoprolol/Hydrochlorothiazide Tablets due to N-Nitroso impurity risk. Other recent recalls of similar products include Major Pharmaceuticals Levothyroxine Tablets Recall (July 13, 2026), Macleods Levothyroxine Tablets Recall (Feb. 26, 2026), and Accord Healthcare Levothyroxine Tablets Recall (Aug. 6, 2026).
How to tell if you have this one
Look for busPIRone Hydrochloride Tablets (5mg) in 500-count bottles with NDC 29300-244-05. The product was manufactured by Unichem Laboratories LTD. in India and distributed by Unichem Pharmaceuticals USA Inc. in the US.
Brand
Unichem Pharmaceuticals
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Medication Details
Verify if your medication matches the description: 500-count busPIRone Hydrochloride Tablets (5mg) with NDC 29300-244-05.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “USA Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 30 days after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The recall is due to subpotent drug content, which may make the medication less effective. It is not safe to use as intended without confirmation of proper potency.
Is there a risk of serious injury?
The recall is for ineffective medication, not a physical hazard. There is no risk of serious injury from this product.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0511-2026 (April 13, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0511-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.