Relpax (eletriptan HBr) 40 mg, a) 12 tablets 2 cards x six 40 mg tablets per blister pack, NDC 00...

FDA Drug Recall #D-1278-2019 — Class III — April 29, 2019

Recall Summary

Recall Number D-1278-2019
Classification Class III — Low risk
Date Initiated April 29, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Pfizer Inc.
Location New York, NY
Product Type Drugs
Quantity 100277 tablets

Product Description

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.

Distribution Pattern

Nationwide in the USA

Lot / Code Information

Lot #s: a) W38322, Exp 10/2020, W98482, Exp 03/2021; b) W64062, Exp 01/2021, X27517, Exp 03/2021, AJ3674, Exp 11/2021.

Other Recalls from Pfizer Inc.

Recall # Classification Product Date
D-0544-2025 Class II Bicillin L-A (penicllin G benzathine injectable... Jul 10, 2025
D-0545-2025 Class II Bicillin L-A (penicillin G benzathine injectabl... Jul 10, 2025
D-0489-2025 Class II DOBUTamine Injection, USP, 250 mg/20 mL (12.5 m... May 28, 2025
D-0565-2024 Class II Labetalol Hydrochloride Injection, USP, 20 mg/4... May 20, 2024
D-0564-2024 Class II Buprenorphine Hydrochloride Injection, 0.3 mg b... May 20, 2024

Frequently Asked Questions

Stop using the medication immediately and contact your pharmacist. A mislabeling recall can range from a minor technical error (wrong font size) to a serious mix-up where one drug is inside another drug's packaging. If you received a medication that looks or acts differently than expected, or if you experienced unexpected effects, tell your doctor immediately. The pharmacist can verify whether your specific lot is affected and provide a replacement. Report any adverse effects experienced to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.