Agency classClass IIOur severity:Moderate FDA (Drugs)·D-1237-2020·Announced 2020-04-22

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.

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 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.
Category: Drug — Prescription Pain Medication
Hazard: manufacturing-deviation
water-leakage
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.

See all 9 products in this recall →

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Same hazard · manufacturing deviation