CLASS II Drug recall · Reported 2 Oct 2019 · FDA Enforcement Report
Fexofenadine HCl Tablets, 180 mg, Pkg Size 90, Mfg: Aurohealth LLC recalled
Preferred Pharmaceuticals is recalling Fexofenadine HCl Tablets, 180 mg, Pkg Size 90, Mfg: Aurohealth LLC, distributed in Florida. The recall was initiated on 29 Aug 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-1877-2019
- FDA event ID
- 83711
- Recalling firm
- Preferred Pharmaceuticals, Anaheim, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Aug 2019
- FDA classified
- 24 Sep 2019
- Reported
- 2 Oct 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Potency & Assay
- Drug class
- Allergy Medication
Timeline
| 29 Aug 2019 | Recall initiated by company | |
| 24 Sep 2019 | Classified by FDA | +26 days |
| 2 Oct 2019 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications
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
Fexofenadine HCl Tablets, 180 mg, Pkg Size 90, Mfg: Aurohealth LLC, Repackaged by Preferred Pharmaceuticals, Inc., Anaheim, CA, NDC #: 68788-6848-09
Where it was distributed
Product was distributed to 1 physician in Gainesville Florida.
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications
Which lots are affected?
Lot #: G0219K, Exp 3/2021; C1419E, Exp 3/2021
Where was it sold?
Product was distributed to 1 physician in Gainesville Florida.
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 26 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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|---|---|---|---|---|---|
| Drug | CLASS II | Artificial Tears Lubricant Eye Drops (glycerin recalledArtificial Tears | Preferred Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Ondansetron ODT Tablets, USP 4mg, unit dose tablets, Mfg recalled | Preferred Pharmaceuticals | Packaging Defects | CA |
| Drug | CLASS II | Clindamycin Hydrochloride Capsules, USP, 300mg recalled | Preferred Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size recalled | Preferred Pharmaceuticals | Potency & Assay | CA, NV |
| Drug | CLASS II | Duloxetine Delayed-Release Cap USP 30mg recalled | Preferred Pharmaceuticals | Nitrosamine Impurity | 5 states |
Other Fexofenadine recalls
All 32| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine recalled | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Fexofenadine Hydrochloride Tablets, USP 180mg recalledFexofenadine Hydrochloride | SUN Pharmaceutical Industries | Sterility | Nationwide |
| Drug | CLASS II | aller-ease, Fexofenadine Hydrochloride Tablets, 180 mg recalledExchange Select Aller Ease | L. Perrigo | Potency & Assay | Nationwide |
| Drug | CLASS II | Allergy Aller-fex, Fexofenadine Hydrochloride Tablets, 180 mg recalledKirkland Signature Aller Fex | L. Perrigo | Potency & Assay | Nationwide |
| Drug | CLASS II | Non-Drowsy Allergy Relief, Fexofenadine Hydrochloride recalledBerkley Jensen Allergy Relief | L. Perrigo | Potency & Assay | Nationwide |