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.
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 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
- 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 →Related recalls
Same brand · ACETAMINOPHEN AND CODEINE PHOSPHATE
- ModerateAurobindo Recalls Acetaminophen and Codeine Tablets Due to Water Leakage
FDA (Drugs) · 2020-04-22
- ModerateAurobindo Recalls Acetaminophen and Codeine Tablets Due to Water Leakage
FDA (Drugs) · 2020-04-22
- ModeratePrescript Pharmaceuticals Recalls Acetaminophen and Codeine Tablets for Labeling Error
FDA (Drugs) · 2018-05-23
Same manufacturer · Aurobindo Pharma USA Inc.
See all →- ModerateDicyclomine Hydrochloride Capsules Recalled for Empty Capsules
FDA (Drugs) · 2026-08-12
- ModerateAmazon Basic Care Acetaminophen 325 mg Tablets Recalled Due to Discoloration
FDA (Drugs) · 2025-06-25
- HighPrescription drug recall: Aurobindo Nebivolol tablets contain excess nitrosamine impurity
FDA (Drugs) · 2024-12-25
- HighPrescription Cinacalcet Tablets Recalled for N-Nitroso Impurity
FDA (Drugs) · 2024-12-11
- HighFDA Recalls Cinacalcet 30mg Tablets for N-nitroso Impurity
FDA (Drugs) · 2024-12-11
Same hazard · manufacturing deviation
See all →- ModerateSynjardy XR Tablets Recalled Due to Manufacturing Deviations
FDA (Drugs) · 2026-07-08
- ModerateDuloxetine delayed-release capsules recalled for N-nitroso impurity contamination
FDA (Drugs) · 2026-05-13
- ModerateFentanyl Citrate Injectable Solution Recalled for cGMP Deviations
FDA (Drugs) · 2026-05-06
- ModerateiVIZIA Dry Eye Lubricant Drops Recalled for Sterility Assurance
FDA (Drugs) · 2026-05-06
- ModerateFurosemide tablets recalled for presence of N-nitroso impurity
FDA (Drugs) · 2026-04-29