Cytotec — Class III drug recall D-0424-2017
Terminated recall by Pfizer Inc., reported 2017-01-18, distributed nationwide. Failed Impurities/Degradations Specifications; Out of specification results for two known degradation products
| Recall number | D-0424-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pfizer Inc., New York, NY, United States |
| Recall initiated | 2016-09-09 |
| Classified | 2017-01-06 |
| Reported by FDA | 2017-01-18 |
| Terminated | 2017-08-18 |
| Distributed | Nationwide (US) |
| Quantity | 1,706 cartons |
| Reason classes | specification failure |
| NDC | 00025-1451, 00025-1451-60, 00025-1461, 00025-1461-31, 00025-1461-34, 00025-1461-60 |
| Lot numbers | B08493, B13230 |
| Expiration dates | 2016-12, 2018-08 |
Product
Cytotec (misoprostol) Tablets, 200 mcg, 100 Tablets blister pack (10X10), For in-institution use only, Rx only, Distributed by G.D. Searle, Division of Pfizer, Inc., NY, NY --- NDC 0025-1461-34
Reason for recall
Failed Impurities/Degradations Specifications; Out of specification results for two known degradation products and total impurities at 18 months
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-0424-2017. 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.