The Recall Desk
ModerateFDA (Drugs)·D-0670-2017·Announced 2017-04-19

Jubilant Cadista Recalls Bupropion Hydrochloride Tablets Due to Impurities

Jubilant Cadista Pharmaceuticals is recalling Bupropion Hydrochloride Extended-release Tablets because they failed impurity specifications.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The FDA classified this as a Class III recall, which indicates the product is not likely to cause adverse health consequences. The hazard involves a chemical impurity, which is a moderate risk compared to immediate physical dangers.

Plain-English summary

Jubilant Cadista Pharmaceuticals, Inc. is recalling Bupropion Hydrochloride Extended-release Tablets, USP (SR), 150 mg. The affected products are packaged in 60-count and 100-count bottles and are available by prescription only.

The recall was initiated because the tablets failed impurities and degradation specifications. Specifically, testing revealed high out-of-specification results for a known degradation product called m-chlorobenzoic acid. The recall covers 81,077 bottles distributed nationwide in the United States.

Patients who have been prescribed this medication should consult their healthcare provider for guidance on alternative treatments. The specific lot numbers and expiration dates for the recalled products are listed in the official FDA recall notice.

The recalled product

Product
BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, packaged in a) 60-count bottles (NDC 59746-316-60) and b) 100-count bottles (NDC 59746-316-01), Rx only, Manufactured by: Julibant Life Sciences Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmace
Manufacturer
Jubilant Cadista Pharmaceuticals, Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
81,077

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (12)

  • Lot #s: a) BU25001A
  • Exp 12/16
  • BU25002A
  • BU25003A
  • BU25004A
  • Exp 01/17
  • b) BU24003A
  • Exp 10/16
  • BU24004A
  • BU24005A
  • Exp 11/16
  • BU25005A

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Jubilant Cadista Pharmaceuticals, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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