FDA Recalls Lurasidone Hydrochloride Tablets Due to Manufacturing Equipment Contamination
Sun Pharmaceutical recalls 9,408 bottles of Lurasidone Hydrochloride 120mg tablets nationwide due to microbial contamination discovered in manufacturing equipment.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a drug with microbial contamination discovered in manufacturing equipment. Drugs are inherently risk-of-harm products. Per the rubric criterion that risk-of-harm products warrant score 3, microbial contamination of a pharmaceutical drug without disclosed serious adverse events receives a score of 3.
Plain-English summary
Lurasidone Hydrochloride 120mg tablets are being recalled by Sun Pharmaceutical Industries, Inc. due to microbial contamination discovered in stagnant water within the ductwork of manufacturing equipment. Approximately 9,408 bottles were distributed nationwide. The affected lot numbers are DNE0621A (expiration 11/30/2024) and DNE0815A (expiration 12/31/2024).
The contamination was identified during Current Good Manufacturing Practice (CGMP) monitoring and is classified as a Class II FDA recall. The specific type of microorganism involved has not been disclosed.
Patients should check with their pharmacist to verify whether their medication comes from one of the affected lots. Those with affected lots should consult their healthcare provider for guidance on appropriate next steps.
The recalled product
- Product
- LURASIDONE HYDROCHLORIDE (LURASIDONE HYDROCHLORIDE)
- Brand
- LURASIDONE HYDROCHLORIDE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug
- Hazard
- Affected units
- 9,408
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 #s: DNE0621A Exp. 11/30/2024
- DNE0815A Exp. 12/31/2024
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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