Aurobindo Recalls Oxycodone and Acetaminophen Tablets Due to Water Leakage
Aurobindo Pharma USA Inc. is recalling specific lots of Oxycodone and Acetaminophen tablets because they were manufactured in an area with observed water leakage.
What this means for you
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 typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard stems from a manufacturing deviation (water leakage) rather than a confirmed contamination or reported injury, fitting the Moderate severity criteria for precautionary recalls.
Plain-English summary
Aurobindo Pharma USA Inc. is recalling Oxycodone and Acetaminophen Tablets, USP 10 mg/325 mg, 100-count bottles. The affected product is identified by NDC 13107-046-01, Lot # 046180056A, and an expiration date of 05/2020. A total of 14,707 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 raises concerns about the integrity of the manufacturing environment.
Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product matches these details, it should be returned to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider for alternative pain management options if they have been using this medication.
The recalled product
- Product
- OXYCODONE AND ACETAMINOPHEN (OXYCODONE AND ACETAMINOPHEN)
- Brand
- OXYCODONE AND ACETAMINOPHEN
- Manufacturer
- Aurobindo Pharma USA Inc.
- Affected units
- 14,707
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 #: 046180056A
- Exp. Date 05/2020
UPCs (1)
- 0313107046018
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.
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