Prescription Drug Recall: Lurasidone Hydrochloride Tablets for Microbial Contamination
Sun Pharmaceutical is recalling 11,400 bottles of Lurasidone Hydrochloride 60mg tablets due to microbial contamination in manufacturing equipment. Patients taking this medication should contact their doctor or pharmacist.
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: FDA Class II recall with microbial contamination in manufacturing equipment and no reported illnesses or injuries, meeting the rubric threshold for Moderate severity.
Plain-English summary
Sun Pharmaceutical Industries Inc is recalling 11,400 bottles of Lurasidone Hydrochloride 60mg tablets (lot DNE0620A, expiration 05/31/2025) due to Current Good Manufacturing Practice (CGMP) deviations. Microbial contamination was identified in stagnant water within the duct of manufacturing equipment.
The affected product (NDC 47335-639-83) was distributed nationwide across the United States. Consumers currently taking this medication should contact their pharmacist or healthcare provider before discontinuing or changing their treatment.
This recall was issued by the Food and Drug Administration and classified as a Class II recall.
The recalled product
- Product
- LURASIDONE HYDROCHLORIDE (LURASIDONE HYDROCHLORIDE)
- Brand
- LURASIDONE HYDROCHLORIDE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Antipsychotic
- Hazard
- Affected units
- 11,400
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)
- Lot #: DNE0620A Exp. 05/31/2025
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 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.
See all 11 products in this recall →Related recalls
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