The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1230-2020·Announced 2020-04-22

Aurobindo Recalls Acetaminophen and Codeine Tablets Due to Manufacturing Deviations

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 indicates a reasonable probability that use may cause temporary or medically reversible health consequences. The hazard is a manufacturing deviation (water leakage) without reported illnesses or injuries, fitting the criteria for a moderate severity score.

Plain-English summary

Aurobindo Pharma USA Inc. is recalling 4,332 units of Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/30 mg, 100-count bottles. The affected product is distributed nationwide within the United States. The specific lots involved are 059180023A, 059180024A, and 059180025A, all with an expiration date of 05/2021.

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 could potentially compromise the quality or safety of the medication.

Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product matches the recalled description, it should be discontinued and returned to the pharmacy or point of purchase for disposal or replacement.

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
4,332

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 (3)

  • Lot #: 059180023A
  • 059180024A and 059180025A
  • Exp. Date 05/2021

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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