CLASS III Drug recall · Reported 13 Mar 2019 · FDA Enforcement Report

BuPROPion Hydrochloride Extended-Release Tablets recalled

Jubilant Cadista Pharmaceuticals is recalling BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150 mg, a) (. The recall was initiated on 28 Feb 2019 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesa) BR117002C, exp. date 11/2019; b) BR117003B and BR117004B, exp. date 11/2019

Quantity recalleda) 3,072 bottles; b) 2,688 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0519-2019
FDA event ID: 82280
Recalling firm: Jubilant Cadista Pharmaceuticals, Salisbury, MD
Classification: Class III
Status: Terminated
Recall initiated: 28 Feb 2019
FDA classified: 6 Mar 2019
Reported: 13 Mar 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: Antidepressants

Timeline

28 Feb 2019	Recall initiated by company
6 Mar 2019	Classified by FDA	+6 days
13 Mar 2019	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Failed Dissolution Specifications; 9-monthstability timepoint

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150 mg, a) 30 count (NDC 59746- 758-30) & b) 90 count (NDC 59746-758-90) bottles, Rx only, Manufactured b Jubilant Generis Ltd, Roorkee, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD

Where it was distributed

Product was distributed to one customer who may have further distributed the product.

Questions about this recall

Why was it recalled?

Failed Dissolution Specifications; 9-monthstability timepoint

Which lots are affected?

a) BR117002C, exp. date 11/2019; b) BR117003B and BR117004B, exp. date 11/2019

Where was it sold?

Product was distributed to one customer who may have further distributed the product.

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Jubilant Cadista Pharmaceuticals

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Other Bupropion recalls

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29 Oct 2025Drug	CLASS II	Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg recalledBupropion Hydrochloride	Graviti Pharmaceuticals Private	Other	Nationwide
17 Jul 2024Drug	CLASS II	buPROPion Hydrochloride Extended-release Tablets recalledBupropion Hydrochloride	Amerisource Health Services	Potency & Assay	Nationwide
17 Jan 2024Drug	CLASS II	buPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150mg recalledBupropion Hydrochloride	Rising Pharma Holding	Other	Nationwide
13 Dec 2023Drug	CLASS III	buPROPion Hydrochloride Extended-Release Tablets, USP (SR) 200 mg recalledBupropion Hydrochloride	SUN Pharmaceutical Industries	Potency & Assay	Nationwide
25 Oct 2023Drug	CLASS III	Bupropion Hydrochloride Extended-Release Tablets USP (SR), 150 mg recalledBupropion Hydrochloride	SUN Pharmaceutical Industries	Potency & Assay	Nationwide