Class II · Moderate risk
Brompheniramine Maleate
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Is Brompheniramine recalled?
Not under an active recall.
Brompheniramine was recalled 8 times in the past — all now closed. Most recent: Mar 15, 2021.
Most common reason: Sterility / contamination (2 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Brompheniramine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Brompheniramine recalls on record
none so far in 2026; 8 on record, newest first
Class II · Moderate risk
Brompheniramine Maleate
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class III · Low risk
Lodrane D (Brompheniramine maleate 4 mg and Pseudoephedrine HCl 60 mg)
Labeling: Not Elsewhere Classified: correctly labeled bottles were packaged in cartons that were mislabeled with an incorrect active ingredient, phenylephrine rather than pseudoephedrine, on the carton face and carton top.
Class II · Moderate risk
Brompheniramine Maleate
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Class II · Moderate risk
Brompheniramine Maleate 20 mg/ml Injectable
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class III · Low risk
Poly-Tussin Ac Liquid
Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only".
Class II · Moderate risk
Brompheniramine 10ml
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Class II · Moderate risk
Brompheniramine/Pseudoephedrine Dm
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
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