CLASS II Drug recall · Reported 26 Jun 2019 · FDA Enforcement Report
Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine recalled
Sun Pharmaceutical Industries is recalling Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended Release, distributed nationwide in the US. The recall was initiated on 5 Jun 2019 and the FDA has classified it as Class II.
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-1388-2019
- FDA event ID
- 83025
- Recalling firm
- Sun Pharmaceutical Industries, Cranbury, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Jun 2019
- FDA classified
- 14 Jun 2019
- Reported
- 26 Jun 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Allergy Medication
Timeline
| 5 Jun 2019 | Recall initiated by company | |
| 14 Jun 2019 | Classified by FDA | +9 days |
| 26 Jun 2019 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended Release Tablets, USP, 20-count box, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895. Made in India. UPC 0 50428 43023 1
Where it was distributed
Nationwide in the USA
Stores named: CVS
Questions about this recall
Is Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended Release recalled?
Yes. Sun Pharmaceutical Industries recalled Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended Release on 5 Jun 2019. The recall is Class II and its status is Terminated. Recall number D-1388-2019.
Why was it recalled?
Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit
Which lots are affected?
Lot GKT0791, EXP 06/2020
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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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|---|---|---|---|---|---|
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