CLASS III Drug recall · Reported 22 May 2019 · FDA Enforcement Report
Relpax (eletriptan HBr) 40 mg, a) 2 cards x six recalled by Pfizer
Pfizer is recalling Relpax (eletriptan HBr) 40 mg, a) 2 cards x six per, distributed nationwide in the US. The recall was initiated on 29 Apr 2019 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1278-2019
- FDA event ID
- 82715
- Recalling firm
- Pfizer, New York, NY
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 29 Apr 2019
- FDA classified
- 13 May 2019
- Reported
- 22 May 2019
- Type
- Voluntary: Firm initiated
- Reason category
- Packaging Defects
Timeline
| 29 Apr 2019 | Recall initiated by company | |
| 13 May 2019 | Classified by FDA | +14 days |
| 22 May 2019 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA
Questions about this recall
Is Relpax (eletriptan HBr) 40 mg, a) 2 cards x six per recalled?
Yes. Pfizer recalled Relpax (eletriptan HBr) 40 mg, a) 2 cards x six per on 29 Apr 2019. The recall is Class III and its status is Terminated. Recall number D-1278-2019.
Why was it recalled?
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.
Which lots are affected?
Lot #s: a) W38322, Exp 10/2020, W98482, Exp 03/2021; b) W64062, Exp 01/2021, X27517, Exp 03/2021, AJ3674, Exp 11/2021.
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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