Wockhardt Recalls BuPROPion HCl Extended-Release Tablets Due to Impurity Levels
Wockhardt USA is recalling 840 bottles of buPROPion HCl Extended-Release Tablets because out-of-specification levels of the impurity m-chlorobenzoic acid were observed.
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 recall is classified as FDA Class III, which the rubric defines as typically scoring 1 or 2 because it is unlikely to cause adverse health consequences. The presence of an out-of-specification impurity warrants a Moderate rating rather than Low due to the potential for chemical exposure, though no specific harm is reported.
Plain-English summary
Wockhardt USA, LLC is recalling 840 bottles of buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 500-count bottles. The product is prescription-only and was distributed nationwide. The recall involves specific lots: DN10635 (Exp 01/15), DM13402 and DN10247 (Exp 11/14), and DM13449 (Exp 07/14).
The recall was initiated because out-of-specification levels of the impurity m-chlorobenzoic acid were observed in the product. This is classified as a Class III recall by the FDA, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or Wockhardt USA for further instructions or a replacement.
The recalled product
- Product
- buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 500-count bottle, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA, LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, NDC 64679-101-07.
- Manufacturer
- Wockhardt Usa Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 840
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 (7)
- Lot #: DN10635
- Exp 01/15
- DM13402
- DN10247
- Exp 11/14
- and DM13449
- Exp 07/14
Distribution
Distributed nationwide across the United States.
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