Acetaminophen Oral Suspension — Class II drug recall D-0095-2022
Terminated recall by Precision Dose Inc., reported 2021-11-17, distributed nationwide. cGMP Deviations: Product manufactured with contaminated raw ingredient.
| Recall number | D-0095-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Precision Dose Inc., South Beloit, IL, United States |
| Recall initiated | 2021-11-01 |
| Classified | 2021-11-05 |
| Reported by FDA | 2021-11-17 |
| Terminated | 2024-07-14 |
| Distributed | Nationwide (US) |
| Quantity | 151,100 units |
| Reason classes | cgmp |
| NDC | 68094-0030, 68094-0030-59, 68094-0030-62, 68094-0231, 68094-0231-01, 68094-0231-58, 68094-0231-59, 68094-0231-61, 68094-0231-62, 68094-0330, 68094-0330-59, 68094-0330-61, 68094-0330-62 |
| Lot numbers | 503679, 503693, 503715 |
Product
Acetaminophen Oral Suspension, 325 mg/10.15 mL, packaged in 10.15 mL per cup (NDC Individual cup: 68094-330-59), in a) 30-count case (NDC 30-count case: 68094-330-62), and b) 100-count case (NDC 100-count case: 68094-330-61), Hospital Use Only, Pkg. Precision Dose, Inc., S. Beloit, IL 61080.
Reason for recall
cGMP Deviations: Product manufactured with contaminated raw ingredient.
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-0095-2022. 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.