Acetaminophen Codeine Tablets (Aurobindo Pharma) – Manufacturing Defect (2020)
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Aurobindo Pharma USA Inc.
Lot Codes / Batch Numbers
Lot #: 060180017A, 060180019B1, 060180020A and 060180021A, Exp. Date 06/2021
Products Sold
Lot #: 060180017A, 060180019B1, 060180020A and 060180021A, Exp. Date 06/2021
Aurobindo Pharma USA Inc. is recalling Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/60 mg, 100-count bottles, Rx Only, Distribu due to CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026