Oxycodone and Acetaminophen Capsules — Class III drug recall D-823-2013
Terminated recall by Watson Laboratories Inc, reported 2013-07-31, distributed nationwide. Subpotent drug: Two lots of Oxycodone and Acetaminophen Capsules, USP 5/500 mg are being recalled due to low o
| Recall number | D-823-2013 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Watson Laboratories Inc, Corona, CA, United States |
| Recall initiated | 2013-07-19 |
| Classified | 2013-07-25 |
| Reported by FDA | 2013-07-31 |
| Terminated | 2014-07-29 |
| Distributed | Nationwide (US) |
| Quantity | 1,260 bottles |
| Reason classes | potency, specification failure |
| NDC | 00591-0737-01, 00591-0737-05 |
Product
Oxycodone and Acetaminophen Capsules, USP 5mg/500 mg, packaged in a)100-count bottle (NDC 0591-0737-01), b) 500-count bottle (NDC 0591-0737-05), Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA92880.
Reason for recall
Subpotent drug: Two lots of Oxycodone and Acetaminophen Capsules, USP 5/500 mg are being recalled due to low out of specification (OOS) assay result obtained at expiry (24 months) for the oxycodone portion of the product.
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-823-2013. 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.