The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1231-2020·Announced 2020-04-22

Aurobindo Recalls Acetaminophen and Codeine Tablets Due to Water Leakage

Aurobindo Pharma USA Inc. is recalling specific lots of Acetaminophen and Codeine Phosphate 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 is a manufacturing deviation (water leakage) without reported illnesses, fitting the Moderate category for low-risk contamination or voluntary precautionary recalls.

Plain-English summary

Aurobindo Pharma USA Inc. is recalling 57,337 units of Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/60 mg, 100-count bottles. The affected product is identified by NDC 13107-060-01 and includes lot numbers 060180017A, 060180019B1, 060180020A, and 060180021A, all with an expiration date of 06/2021.

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 regarding the integrity and safety of the drug product.

The affected units were distributed nationwide within the United States. Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be returned to the pharmacy or point of purchase for a refund or replacement, or disposed of according to local regulations.

The recalled product

Product
ACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN AND CODEINE PHOSPHATE)
Brand
ACETAMINOPHEN AND CODEINE PHOSPHATE
Manufacturer
Aurobindo Pharma USA Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
57,337

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 (4)

  • Lot #: 060180017A
  • 060180019B1
  • 060180020A and 060180021A
  • Exp. Date 06/2021

UPCs (1)

  • 0313107058011

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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