FDAClass IIJuly 17, 2024

buPROPion Hydrochloride Extended-release Tablets USP recall: Failed Dissolution

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.

Why was buPROPion Hydrochloride Extended-release Tablets USP recalled?

Failed Dissolution Specifications; the product is dissolving faster than the specified limits.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot 1017343, Exp. 12/31/2025

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 firm
Amerisource Health Services LLC
Quantity
2,484 cartons
Distribution
Nationwide in the USA
Recall date
July 17, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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