Sun Pharmaceutical Recalls Alfuzosin Hydrochloride Tablets Due to Foreign Matter
Sun Pharmaceutical Industries is recalling specific lots of Alfuzosin Hydrochloride Extended-release Tablets because a consumer complaint identified a broken piece of wire rope embedded in a tablet.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 II, which typically involves temporary or medically reversible adverse health consequences. The hazard is a foreign object (wire rope) in a tablet, which is a significant quality issue but does not meet the criteria for Class I (death/serious injury) or Class III (unlikely to cause adverse health consequences).
Plain-English summary
Sun Pharmaceutical Industries, Inc. is recalling 22,915 bottles of Alfuzosin Hydrochloride Extended-release Tablets, 10 mg, 100-count bottles. The affected product is distributed nationwide in the USA and Puerto Rico. The specific lots involved are JKR5219A, JKR5200A, JKR5220A, JKR5221A, and JKR5222A, all with an expiration date of 03/18.
The recall was initiated following a consumer complaint regarding foreign matter embedded in a tablet. The foreign substance was identified as a broken piece of wire rope from the manufacturing equipment. This is a Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers who have these specific lots of Alfuzosin Hydrochloride should stop using the product and contact their healthcare provider or pharmacist for guidance. The product is prescription-only, so patients should consult their prescriber regarding alternative treatments or next steps.
The recalled product
- Product
- ALFUZOSIN HYDROCHLORIDE (ALFUZOSIN HYDROCHLORIDE)
- Brand
- ALFUZOSIN HYDROCHLORIDE
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Category
- Drug — Prescription Drug
- Affected units
- 22,915
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 (6)
- Lot #: JKR5219A
- JKR5200A
- JKR5220A
- JKR5221A
- JKR5222A
- Exp 03/18
UPCs (1)
- 0347335956818
Distribution
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