Sun Pharmaceutical Recalls BuPROPion Hydrochloride Tablets for Dissolution Failures
Sun Pharmaceutical Industries is recalling 11,618 bottles of buPROPion Hydrochloride Extended-release Tablets due to failed dissolution specifications and stability issues.
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 2/5 (Moderate).
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 recall is classified as FDA Class III, which typically corresponds to a severity score of 1 or 2. Given the nature of the defect (dissolution/stability), a score of 2 is appropriate as it is a quality issue but not a cosmetic or packaging-only problem.
Plain-English summary
Sun Pharmaceutical Industries, Inc. is recalling 11,618 bottles of buPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, 60 count bottles. The product is distributed nationwide and is available by prescription only. The specific lot code is JKP0905A with an expiration date of 04/17.
The recall was initiated because the product failed dissolution specifications and the 18-month stability time point. These are quality control failures that may affect the performance of the medication.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for a replacement or refund. The recall is classified as Class III by the FDA, indicating that the product is unlikely to cause adverse health consequences.
The recalled product
- Product
- buPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, 60 count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC…
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 11,618
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 (1)
- JKP0905A 04/17
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Sun Pharmaceutical Industries, 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.
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