Class II · Moderate risk
Chlorpheniramine Maleate 4 mg tablets
Superpotent Drug: Stability failure for assay at 6 months test time-point.
Is Chlorpheniramine recalled?
Yes — there is an active recall. 1 ongoing FDA recall mention Chlorpheniramine (22 total). Check the affected lots below.
Most common reason: Impurity / degradation (5 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Chlorpheniramine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Chlorpheniramine recalls on record
none so far in 2026; 22 on record, newest first
Class II · Moderate risk
Broncochem Cold & Tea
Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.
Class II · Moderate risk
Chlorpheniramine/Hyoscyamine
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Ibuprofen 200 mg Chlorpheniramine Maleate 4mg Phenylephrine 10 mg…
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Class II · Moderate risk
Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension
Superpotent Drug and Failed Stability Specifications: High out-of-specification results for the active ingredients, hydrocodone and chlorpheniramine, as well as high out-of-specification results for the preservatives.
Class II · Moderate risk
Gencontuss
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Class II · Moderate risk
Kid Kare Childrens Cough/Cold Liquid
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Pedia Relief Cough-Cold Oral Solution
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Rugby Aller-chlor
Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
Class II · Moderate risk
Rugby Aller-chlor
Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
Class II · Moderate risk
Aller-Chlor
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk
Chlorpheniramine Maleate 10 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Peng/proc/strep/chlor/hyos
Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
Class II · Moderate risk
Theraflu Exte
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Class II · Moderate risk
NeoCitran
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Class II · Moderate risk
NeoCitran Extra Strength
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Class III · Low risk
Theraflu Nighttime Warming Relief Nighttime Multi-Symptom Cold
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Class III · Low risk
Maximum Strength Comtrex
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Class III · Low risk
Maximum Strength Comtrex
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Class III · Low risk
Maximum Strength Comtrex Nighttime Cold & Cough
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Class III · Low risk
Maximum Strength Comtrex Day/Night Cold & Cough
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Class II · Moderate risk
Pentrexcilina
Labeling: Not Elsewhere Classified: Pentrexcilina Tablets and Pentrexcilina Liquid are being recalled because the product labels are misleading because they may be confused with Pentrexyl, a prescription antibiotic used to treat respiratory illnesses in Mexico.
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