Acetaminophen and Codeine Phosphate Tablets — Class II drug recall D-1230-2020
Terminated recall by Aurobindo Pharma USA Inc., reported 2020-04-22, distributed nationwide. CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
| Recall number | D-1230-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aurobindo Pharma USA Inc., East Windsor, NJ, United States |
| Recall initiated | 2020-03-18 |
| Classified | 2020-04-13 |
| Reported by FDA | 2020-04-22 |
| Terminated | 2024-03-25 |
| Distributed | Nationwide (US) |
| Quantity | 4,332 units |
| Reason classes | cgmp, packaging |
| NDC | 13107-0058, 13107-0058-01, 13107-0058-05, 13107-0058-30, 13107-0058-99, 13107-0059, 13107-0059-01, 13107-0059-05, 13107-0059-30, 13107-0059-99, 13107-0060, 13107-0060-01, 13107-0060-05, 13107-0060-30, 13107-0060-99 |
| Lot numbers | 059180023A, 059180024A, 059180025A |
| Expiration dates | 2021-05 |
Product
Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/30 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-059-99
Reason for recall
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1230-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.