Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Acetaminophen and Codeine Phosphate Tablets Recalled by Aurobindo Pharma USA Inc. Due to CGMP Deviations: Products were manufactured in a processing...
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 Aurobindo Pharma USA Inc. directly.
Affected Products
Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/60 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-060-01
Quantity: 57337 units
Why Was This Recalled?
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Aurobindo Pharma USA Inc.
Aurobindo Pharma USA Inc. has 47 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report