Oxycodone and Acetaminophen Tablets — Class II drug recall D-1237-2020
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-1237-2020 |
|---|---|
| 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 | 14,707 units |
| Reason classes | cgmp, packaging |
| NDC | 13107-0043, 13107-0043-01, 13107-0043-05, 13107-0043-30, 13107-0043-99, 13107-0044, 13107-0044-01, 13107-0044-05, 13107-0044-30, 13107-0044-99, 13107-0045, 13107-0045-01, 13107-0045-05, 13107-0045-30, 13107-0045-99, 13107-0046, 13107-0046-01, 13107-0046-05, 13107-0046-30, 13107-0046-99 |
| Lot numbers | 046180056A |
| Expiration dates | 2020-05 |
Product
Oxycodone and Acetaminophen Tablets, USP 10 mg*/325 mg 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 13107-046-01
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-1237-2020. 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.