Oxycodone and Acetaminophen Tablets — Class III drug recall D-1129-2018
Terminated recall by Mayne Pharma Inc, reported 2018-09-05, distributed nationwide. Labeling: Incorrect or Missing Lot and/or Exp Date: Lot FG10517 is mislabeled on the primary container with Lo
| Recall number | D-1129-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mayne Pharma Inc, Greenville, NC, United States |
| Recall initiated | 2018-08-21 |
| Classified | 2018-08-28 |
| Reported by FDA | 2018-09-05 |
| Terminated | 2020-05-19 |
| Distributed | Nationwide (US) |
| Quantity | 6,456 bottles |
| Reason classes | labeling |
| NDC | 68308-0841-01 |
| Lot numbers | FG01517 |
| Expiration dates | 2019-12-31 |
Product
Oxycodone and Acetaminophen Tablets, USP, 5 mg*/325 mg, 100-count bottle, Rx Only, Manufactured by: Mayne Pharma, Greenville, NC 27834, NDC 68308-841-01.
Reason for recall
Labeling: Incorrect or Missing Lot and/or Exp Date: Lot FG10517 is mislabeled on the primary container with Lot FG01517, shipper labels and invoices contain the correct lot number of FG10517.
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-1129-2018. 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.