busPIRone Hydrochloride Tablets recall
FDA recall D-0511-2026 · initiated Apr 13, 2026
Unichem Pharmaceuticals USA Inc. recalled busPIRone Hydrochloride Tablets in Apr 2026 — an FDA Class III recall (D-0511-2026) because Subpotent drug.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Subpotent drug
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 10,875 Bottles
Details
- Product
- 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.
- Recalling company
- Unichem Labs Ltd
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- USA Nationwide
- Initiated
- Apr 13, 2026
- FDA report date
- May 13, 2026
Frequently asked
- Was busPIRone Hydrochloride Tablets recalled?
- Unichem Pharmaceuticals USA Inc. recalled busPIRone Hydrochloride Tablets in Apr 2026 — an FDA Class III recall (D-0511-2026) because Subpotent drug. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was busPIRone Hydrochloride Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0511-2026 was: Subpotent drug
- Is a recalled busPIRone Hydrochloride Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of busPIRone Hydrochloride Tablets are affected?
- Distributed: USA Nationwide. The recall covers these lots — Lot: ZBUL25001, Exp 12/31/2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0511-2026.