Acetaminophen Tablets — Class II drug recall D-1064-2013
Terminated recall by Marlex Pharmaceuticals, Inc., reported 2013-10-09, distributed nationwide. CGMP Deviations: The recalled acetaminophen tablet lot was not manufactured under current good manufacturing p
| Recall number | D-1064-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Marlex Pharmaceuticals, Inc., New Castle, DE, United States |
| Recall initiated | 2013-08-08 |
| Classified | 2013-09-27 |
| Reported by FDA | 2013-10-09 |
| Terminated | 2014-11-20 |
| Distributed | Nationwide (US) |
| Quantity | 28,387 bottles |
| Reason classes | cgmp |
| UPC / GTIN / UDI-DI | 00310135152018 |
| NDC | 10135-0152-01 |
| Lot numbers | 12/13, 3213 |
Product
Acetaminophen Tablets, 500 mg, 100-count bottles, Distributed by: Marlex Pharmaceuticals, Inc., New Castle, DE 19720, List No. 152, NDC 10135-152-01, UPC 3 10135 15201 8.
Reason for recall
CGMP Deviations: The recalled acetaminophen tablet lot was not manufactured under current good manufacturing practices as noted by a recent inspection of the manufacturing firm.
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-1064-2013. 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.