The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0519-2019·Announced 2019-03-13

Jubilant Cadista Recalls Bupropion Hydrochloride Extended-Release Tablets for Dissolution Failure

Jubilant Cadista Pharmaceuticals is recalling specific lots of Bupropion Hydrochloride Extended-Release Tablets because they failed dissolution specifications at a 9-month stability timepoint.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this recall as Class III, which by definition indicates that use of or exposure to the violative product is not likely to cause adverse health consequences. The hazard is a failure to meet dissolution specifications, which is a quality control issue rather than a direct safety threat like contamination or mislabeling.

Plain-English summary

Jubilant Cadista Pharmaceuticals, Inc. is recalling specific lots of BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150 mg. The recall involves 30-count and 90-count bottles of the prescription medication. The affected lots are identified by the following codes and expiration dates: BR117002C (exp. 11/2019), BR117003B (exp. 11/2019), and BR117004B (exp. 11/2019).

The recall was initiated because the product failed dissolution specifications at a 9-month stability timepoint. This means the tablets may not release the medication into the body as intended, potentially affecting the drug's efficacy. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.

The product was distributed to one customer who may have further distributed it. Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be returned to the distributor or disposed of according to local regulations. Patients should consult their healthcare provider for alternative treatment options if they are currently taking the affected medication.

The recalled product

Product
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
Manufacturer
Jubilant Cadista Pharmaceuticals, Inc.
Category
Drug — Prescription Medication
Hazard

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 (3)

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

Distribution

Distribution scope not specified by the agency.

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