Chlorthalidone Tablets Recalled for Foreign Matter Contamination
Sun Pharmaceutical is recalling Chlorthalidone Tablets USP 25 mg (Lot #P0602, expiration 03/2023) due to stainless steel microscopic wear particles, punch lubricant oil, and silicone particles from the dust cup found in the product.
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: This is an FDA Class II recall involving foreign matter contamination (a manufacturing defect). The hazard is a product quality issue involving microscopic particles. No illness or injury has been reported, and the particles are microscopic in size, placing this in the moderate category for a precautionary Class II drug recall.
Plain-English summary
Sun Pharmaceutical Industries Inc. is recalling Chlorthalidone Tablets USP 25 mg, 100-tablet bottles (NDC 57664-648-88 and related NDCs), distributed nationwide in the United States. The recall was initiated because foreign matter—identified as stainless steel microscopic wear particles mixed with punch lubricant oil and silicone particles from the dust cup—has been identified in the product.
The affected product is Lot #P0602 with an expiration date of 03/2023. A total of 59,232 bottles have been distributed. The product was manufactured by Fontida Bio Pharm Inc. and distributed by Sun Pharmaceutical Industries, Inc.
Consumers who have this medication should discontinue use and consult their healthcare provider about their chlorthalidone therapy. Healthcare providers and pharmacies should quarantine and not dispense this lot. The recalling firm requests that consumers, pharmacies, and healthcare providers report any adverse events to the FDA or Sun Pharmaceutical.
The recalled product
- Product
- CHLORTHALIDONE (CHLORTHALIDONE)
- Brand
- CHLORTHALIDONE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Affected units
- 59,232
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 (2)
- Lot #: P0602
- Exp. Date 03/2023
UPCs (2)
- 0357664648889
- 0357664649886
Distribution
Distributed nationwide across the United States.
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