Class II · Moderate risk
Allergy Liquid Antihistamine
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Is Diphenhydramine recalled?
Yes — there is an active recall. 8 ongoing FDA recalls mention Diphenhydramine (49 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Diphenhydramine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Diphenhydramine recalls on record
none so far in 2026; 49 on record, newest first
Class II · Moderate risk
CVS Health Children's Allergy Relief Liquid Medication…
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk
DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistamine
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk
Diphenhydramine HCl USP f
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class II · Moderate risk
Doctor Manzanilla Cough & Cold
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
Doctor Manzanilla Allergy & Decongestant Relief
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Class III · Low risk
Allergy Relief Diphenhydramine HCl 25 mg
Subpotent: This product is being recalled due to low out of specification assay results at the 9 month time point.
Class III · Low risk
Diphenhydramine HCl 25 mg
Subpotent
Class II · Moderate risk
Diphenhydramine HCl
Lack of Assurance of Sterility: Sterility of product is not assured.
Class I · High risk
Mucinex Fast Max Night Time Cold & Flu
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 II · Moderate risk
DICOPANOL (diphenhydramine hydrochloride in 5 mg/mL oral suspension kit)
Microbial Contamination of a Non-Sterile Product: Kit component is contaminated with Burkholderia multivorans.
Class II · Moderate risk
Diphenhydramine 50 mg/ml vials
Lack of sterility assurance.
Class II · Moderate risk
Diphenhydramine
Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Class III · Low risk
PediaCare brand DAY & NIGHT Value Pack DAYTIME MULTI-SYMPTOM Cold
Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution
Class III · Low risk
PediaCare brand NIGHTTIME MULTI-SYMPTOM Cold
Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution
Class III · Low risk
Children's Triacting Night Time Cold & Cough with PE
Presence of Precipitate: Small amounts of diphenydramine and mannitol precipitated out of solution.
Class III · Low risk
Advil PM Caplets
Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphenhydramine citrate.
Class II · Moderate risk
diphenhydrAMINE HCl
Labeling: Label Mixup; diphenhydrAMINE HCl, Tablet, 25 mg may be potentially mislabeled as ATORVASTATIN CALCIUM, Tablet, 40 mg, NDC 00378212177, Pedigree: AD33897_10, EXP: 5/9/2014; ATORVASTATIN CALCIUM, Tablet, 10 mg, NDC 00378201577, Pedigree: W002774, EXP: 6/6/2014; PRENATAL MULTIVITAMIN/ MULTIMINERAL, Tablet, NDC 51991056601, Pedigree: W003511, EXP: 6/21/2014; VENLAFAXINE, Tablet, 25 mg
Class II · Moderate risk
Theraflu Nighttime Severe Cold & Cough
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Class II · Moderate risk
Theraflu Sugar-Free Nighttime Severe Cold & Cough
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Class II · Moderate risk
Theraflu Severe Cold & Cough powder packets containing Daytime formula
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Class II · Moderate risk
Diphenhydramine 50 mg/ml Injection
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Pure-Aid Allergy Relief
Labeling: Not Elsewhere Classified; foil label on immediate blister pack indicates active ingredient as Chlorpheniramine rather than Diphenhydramine
Class II · Moderate risk
Diphenhydramine 25mg/Ml Injectable 90 Ml
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
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