Penicillin V Potassium for Oral Solution — Class III drug recall D-0108-2018
Terminated recall by Teva Pharmaceuticals USA, reported 2017-12-20, distributed nationwide. Failed Impurities/Degradation Specifications: high out of specification test results obtained for individual a
| Recall number | D-0108-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, North Wales, PA, United States |
| Recall initiated | 2017-11-28 |
| Classified | 2017-12-13 |
| Reported by FDA | 2017-12-20 |
| Terminated | 2018-07-03 |
| Distributed | Nationwide (US) |
| Quantity | 42,384 bottles |
| Reason classes | specification failure |
| NDC | 00093-1172, 00093-1172-01, 00093-1172-10, 00093-1174, 00093-1174-01, 00093-1174-10, 00093-4125, 00093-4125-73, 00093-4125-74, 00093-4127, 00093-4127-73, 00093-4127-74 |
| Lot numbers | 01/18, 35433115A |
Product
Penicillin V Potassium for Oral Solution, USP, 125 mg (200,000 U) per 5 mL, 100 mL (when mixed) bottle, Rx only, Manufactured In Canada By: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454; NDC 0093-4125-73.
Reason for recall
Failed Impurities/Degradation Specifications: high out of specification test results obtained for individual and total impurities.
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-0108-2018. 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.