PROTONIX I — Class III drug recall D-0516-2017
Terminated recall by Pfizer Inc., reported 2017-03-22, distributed nationwide. Subpotent Drug: Out of Specification (OOS) for potency at the 6-month stability time point.
| Recall number | D-0516-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pfizer Inc., New York, NY, United States |
| Recall initiated | 2016-11-22 |
| Classified | 2017-03-10 |
| Reported by FDA | 2017-03-22 |
| Terminated | 2018-06-22 |
| Distributed | Nationwide (US) |
| Quantity | 582,165 vials |
| Reason classes | potency, specification failure |
| NDC | 00008-0923, 00008-0923-51, 00008-0923-55, 00008-0923-60, 00008-0941-01, 00008-0941-03, 00008-4001, 00008-4001-01, 00008-4001-10, 00008-4001-25 |
Product
PROTONIX I.V. (pantoprazole sodium) for Injection, Equivalent to 40 mg pantoprazole per vial, For I.V. infusion only, Rx Only, Distributed by Wyeth Pharmaceuticals Inc, A subsidiary of Pfizer Inc, Philadelphia, PA 19101, Under license from Takeda GmbH, D78467 Konstanz, Germany, MADE IN FRANCE; packaged in A) Pfizer Injectables, 1 vial per carton (NDC 0008-0923-51) in a) bundles of 10 unit cartons (NDC 0008-0923-55) and b) 25 x 40 mg Vials per carton (NDC 0008-0923-60); B) NOVAPLUS, 1 vial per carton (NDC 00008-0941-01) in 25 x 40 mg Vials per carton (NDC 0008-0941-03); and C) PREMIERPro Rx, 1 vial per carton (NDC 0008-4001-01) in a) bundles of 10 unit cartons (NDC 0008-4001-10) and b) 25 x 40 mg Vials per carton (NDC 0008-4001-25).
Reason for recall
Subpotent Drug: Out of Specification (OOS) for potency at the 6-month stability time point.
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-0516-2017. 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.