Class III · Low risk
Allergy Relief D
Failed dissolution specifications
Is Pseudoephedrine recalled?
Not under an active recall.
Pseudoephedrine was recalled 43 times in the past — all now closed. Most recent: Nov 21, 2022.
Most common reason: Dissolution failure (19 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Pseudoephedrine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Pseudoephedrine recalls on record
none so far in 2026; 43 on record, newest first
Class III · Low risk
Mucus Relief D
Subpotent drug
Class III · Low risk
Leader
Failed Dissolution Specifications
Class III · Low risk
CVS Health
Failed Dissolution Specifications
Class III · Low risk
Qc Quality Choice
Failed Dissolution Specifications
Class III · Low risk
equate
Failed Dissolution Specifications
Class III · Low risk
Dr. Reddys
Failed Dissolution Specifications
Class III · Low risk
Kroger
Failed Dissolution Specifications
Class III · Low risk
Rite Aid Pharmacy
Failed Dissolution Specifications
Class III · Low risk
Rugby
Failed Dissolution Specifications
Class III · Low risk
Wal-Fex D
Failed Dissolution Specifications
Class III · Low risk
Fexofenadine HCl
Failed dissolution specifications
Class III · Low risk
Allergy Relief D Fexofenadine HCl
Failed dissolution specifications
Class III · Low risk
Allergy Relief D Fexofenadine HCl
Failed dissolution specifications
Class III · Low risk
12 HR Allergy & Congestion Relief Fexofenadine HCl
Failed dissolution specifications
Class III · Low risk
Antihistamine & Nasal Decongestant
Failed dissolution specifications
Class III · Low risk
Antihistamine & Nasal Decongestant
Failed dissolution specifications
Class III · Low risk
Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended…
Failed dissolution specifications
Class III · Low risk
Allergy & Congestion Relief Allergy Relief D
Failed dissolution specifications
Class III · Low risk
Allergy & Congestion Fexofenadine HCl 60 mg & Pseudoephedrine HCl…
Failed dissolution specifications
Class III · Low risk
AllerClear D-24 hr
Failed Moisture Limits
Class III · Low risk
Loratadine-D Extended-Release Tablets
Failed Moisture Limits
Class II · Moderate risk
Brompheniramine Maleate
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Brompheniramine Maleate
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg
Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit
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