Children's Acetaminophen Oral Suspension — Class II drug recall D-250-2013
Terminated recall by Precision Dose Inc., reported 2013-04-24, distributed nationwide. Labeling: Not Elsewhere Classified: This unit dose product is being recalled because the product's name includ
| Recall number | D-250-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Precision Dose Inc., South Beloit, IL, United States |
| Recall initiated | 2013-03-21 |
| Classified | 2013-04-15 |
| Reported by FDA | 2013-04-24 |
| Terminated | 2015-05-07 |
| Distributed | Nationwide (US) |
| Quantity | 9,268 cases |
| Reason classes | labeling |
| NDC | 68094-0650-59, 68094-0650-62 |
| Lot numbers | 03/14, 05/13, 06/13, 07/13, 08/13, 10/13, 101456, 101488, 101499, 101503, 101537, 101552, 101554, 101611, 101616, 101623, 101630, 101754, 11/13 |
Product
Children's Acetaminophen Oral Suspension, 650 mg/20.3 mL unit dose cup (NDC 68094-650-59), packaged in 30-count cups per shipper case (NDC 68094-650-62), Pkg. By: Precision Dose, Inc., S. Beloit, IL 61080.
Reason for recall
Labeling: Not Elsewhere Classified: This unit dose product is being recalled because the product's name includes the word "Children's" which is misleading since the 650 mg dose of acetaminophen contained within it, is an adult dose.
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-250-2013. 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.