Oxycodone and Acetaminophen Tablets USP 10 mg/325 mg 100 count… — Class II drug recall D-1607-2014
Terminated recall by Alvogen, Inc, reported 2014-10-01, distributed nationwide. Failed Content Uniformity Specifications - The lot failed to meet the acceptance criteria for Uniformity of Do
| Recall number | D-1607-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alvogen, Inc, Pine Brook, NJ, United States |
| Recall initiated | 2014-08-28 |
| Classified | 2014-09-23 |
| Reported by FDA | 2014-10-01 |
| Terminated | 2015-04-30 |
| Distributed | Nationwide (US) |
| Quantity | 8,964 |
| NDC | 47781-0230-01 |
| Lot numbers | 453289 |
| Expiration dates | 2015-08-31 |
Product
Oxycodone and Acetaminophen Tablets USP 10 mg/325 mg 100 count bottles Rx Only. Manufactured by Norwich Pharmaceuticals Inc., Norwich, NY 13185 USA; Distributed by Alvogen Inc, Pine Brook NJ 07058 USA.
Reason for recall
Failed Content Uniformity Specifications - The lot failed to meet the acceptance criteria for Uniformity of Dosage Units at the time of release for the oxycodone component.
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-1607-2014. 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.