Aurobindo Recalls Simvastatin Tablets Due to Manufacturing Water Leakage
Aurobindo Pharma USA Inc. is recalling specific lots of Simvastatin 40mg tablets because they were manufactured in an area with observed water leakage.
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 indicates a reasonable probability of temporary or medically reversible adverse health consequences. The hazard stems from a manufacturing deviation (water leakage) rather than a confirmed high-risk pathogen or structural defect, fitting the Moderate category for precautionary quality recalls.
Plain-English summary
Aurobindo Pharma USA Inc. is recalling Simvastatin Tablets, USP 40mg, 90-count bottles (NDC 65862-053-90). The affected product is identified by Lot # 05319004A1 and an expiration date of 03/2022. A total of 26,976 units were distributed nationwide within the United States.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the products were manufactured in a processing area where water leakage was observed. This condition may have compromised the quality or safety of the medication.
Consumers who possess this specific lot of Simvastatin should stop using it and contact their healthcare provider or pharmacist for guidance. They should return the product to the pharmacy or point of purchase for a refund or replacement.
The recalled product
- Product
- SIMVASTATIN (SIMVASTATIN)
- Brand
- SIMVASTATIN
- Manufacturer
- Aurobindo Pharma USA Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 26,976
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 #: 05319004A1
- Exp. Date 03/2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 recalled by Aurobindo Pharma USA 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 9 products in this recall →Related recalls
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