Relpax — Class III drug recall D-1278-2019
Terminated recall by Pfizer Inc., reported 2019-05-22, distributed nationwide. Labeling: Label Error on Declared Strength: an artwork error on the secondary packaging of Relpax 40 mg Tablet
| Recall number | D-1278-2019 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pfizer Inc., New York, NY, United States |
| Recall initiated | 2019-04-29 |
| Classified | 2019-05-13 |
| Reported by FDA | 2019-05-22 |
| Terminated | 2021-04-26 |
| Distributed | Nationwide (US) |
| Quantity | 100,277 tablets |
| Reason classes | labeling, potency |
| NDC | 00049-2340-05, 00049-2340-45 |
| Expiration dates | 2020-10, 2021-01, 2021-03, 2021-11 |
Product
Relpax (eletriptan HBr) 40 mg, a) 12 tablets 2 cards x six 40 mg tablets per blister pack, NDC 0049-2340-05; b) 6 tablets 1 card x six 40 mg tablets per blister pack, NDC 0049-2340-45, Rx Only, Made in Ireland, Distributed by Roerig, Division of Pfizer Inc, NY NY 10017.
Reason for recall
Labeling: Label Error on Declared Strength: an artwork error on the secondary packaging of Relpax 40 mg Tablets, indicates that each tablet contains eletriptan hydrobromide equivalent to 20mg eletriptan, instead of 40mg, on one side of the carton.
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-1278-2019. 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.