Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Mirtazapine Tablets Recalled by AuroMedics Pharma LLC Due to Labeling: Label Error on Declared Strength; cases labelled...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact AuroMedics Pharma LLC directly.
Affected Products
Mirtazapine Tablets, USP, 15 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 13107-031-05
Quantity: N/A
Why Was This Recalled?
Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About AuroMedics Pharma LLC
AuroMedics Pharma LLC has 36 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report