buPROPion Hydrochloride Extended-release Tablets USP (XL) Once-Daily recall
FDA recall D-0590-2024 · initiated Jun 24, 2024
Amerisource Health Services LLC recalled buPROPion Hydrochloride Extended-release Tablets USP (XL) Once-Daily in Jun 2024 — an FDA Class II recall (D-0590-2024) because Failed Dissolution Specifications; the product is dissolving faster than the specified limits.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Dissolution Specifications; the product is dissolving faster than the specified limits.
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: 2,484 cartons
Details
- Product
- buPROPion Hydrochloride Extended-release Tablets USP (XL) Once-Daily, 150 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC: 60687-782-01.
- Recalling company
- Amerisource Health Services LLC
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Jun 24, 2024
- FDA report date
- Jul 17, 2024
Frequently asked
- Was buPROPion Hydrochloride Extended-release Tablets USP (XL) Once-Daily recalled?
- Amerisource Health Services LLC recalled buPROPion Hydrochloride Extended-release Tablets USP (XL) Once-Daily in Jun 2024 — an FDA Class II recall (D-0590-2024) because Failed Dissolution Specifications; the product is dissolving faster than the specified limits. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was buPROPion Hydrochloride Extended-release Tablets USP (XL) Once-Daily recalled?
- Per the FDA enforcement record, the reason for recall D-0590-2024 was: Failed Dissolution Specifications; the product is dissolving faster than the specified limits.
- Is a recalled buPROPion Hydrochloride Extended-release Tablets USP (XL) Once-Daily 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. May cause temporary or medically reversible harm; low probability of serious harm. 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 buPROPion Hydrochloride Extended-release Tablets USP (XL) Once-Daily are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot 1017343, Exp. 12/31/2025. 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-0590-2024.