Class II · Moderate risk Terminated
Fexofenadine Hydrochloride Tablets
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Is Histamine recalled?
Yes — there is an active recall. 4 ongoing FDA recalls mention Histamine (109 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Histamine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed.
Class II · Moderate risk Terminated
Banophen Diphenhydramine HCl 25 mg Antihistamine 100 capsules…
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
NOHIST-DM Antihistamine/Antitussive Nasal Decongestant 16 fl. oz.
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class III · Low risk Terminated
Discount Drug Mart
Reason Labeling: Incorrect or Missing Lot and/or Expiration date.
Class II · Moderate risk Terminated
AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg
Reason Failed Stability Specifications.
Class II · Moderate risk Terminated
DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistamine
Reason CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk Terminated
CVS Health Children's Allergy Relief Liquid Medication…
Reason CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk Terminated
AbeeMed cream
Reason 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 Terminated
Cetirizine Oral Solution 1 mg/mL
Reason cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk Terminated
Cetirizine Oral Solution 1 mg/mL
Reason cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk Terminated
Cetirizine HCL Oral Solution 1 mg/mL
Reason cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk Terminated
Kid Kare Childrens Cough/Cold Liquid
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk Terminated
Pedia Relief Cough-Cold Oral Solution
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk Terminated
Allergy Liquid Antihistamine
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk Terminated
CVS Health Children's Allergy Relief Liquid Medication…
Reason CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk Terminated
DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistamine
Reason CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk Terminated
children's allergy
Reason Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
Class III · Low risk Terminated
Allergy Relief Diphenhydramine HCl 25 mg
Reason Subpotent: This product is being recalled due to low out of specification assay results at the 9 month time point.
Class III · Low risk Terminated
Loratadine Orally Disintegrating Tablets USP
Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class I · High risk Terminated
Mucinex Fast Max Night Time Cold & Flu
Reason Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
Class III · Low risk Terminated
Fexofenadine Hydrochloride Tablets
Reason Failed Impurities/Degradation Specifications: the manufacturer, recalled product due to slightly above specification results for a Related Compound during routine stability testing
Class III · Low risk Terminated
Fexofenadine HCl Tablets
Reason Failed Impurities/Degradation Specifications: out of specification results for a related compound - a degradant of fexofenadine.
Class II · Moderate risk Terminated
Children's Loratadine Syrup
Reason Presence of Foreign Substance: Presence of blue plastic floating in loratadine syrup.
Class II · Moderate risk Terminated
Histamine Phosphate active pharmaceutical ingredient packaged in…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk Terminated
Histamine Diphosphate active pharmaceutical ingredient packaged…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
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