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 is a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The hazard is a manufacturing deviation (water leakage) without reported illnesses, fitting the Moderate category.
Plain-English summary
Aurobindo Pharma USA Inc. is recalling 14,194 units of Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/15 mg, 100-count bottles. The affected product is distributed nationwide within the United States. The specific lots involved are 058180015A and 058180016A (expiration date 07/2021) and 05818017B1 (expiration date 09/2021). The product is identified by NDC 13107-058-01.
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 may 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 distributor. Patients should consult their healthcare provider for alternative treatment options if necessary.
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
- Affected units
- 14,194
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 (5)
- Lot #: 058180015A
- 058180016A
- Exp. Date 07/2021
- 05818017B1
- Exp. Date 09/2021
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 →Related recalls
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