49 FDA recalls mention Diphenhydramine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Diphenhydramine.
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Reason CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Reason CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure…
Reason CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Reason CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Reason Subpotent: This product is being recalled due to low out of specification assay results at the 9 month time point.
Reason Subpotent
Reason Lack of Assurance of Sterility: Sterility of product is not assured.
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…
Reason Microbial Contamination of a Non-Sterile Product: Kit component is contaminated with Burkholderia multivorans.
Reason Lack of sterility assurance.
Reason Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Reason Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution
Reason Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution
Reason Presence of Precipitate: Small amounts of diphenydramine and mannitol precipitated out of solution.
Reason Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphenhydramine citrate.
Reason Labeling: Label Mixup; diphenhydrAMINE HCl, Tablet, 25 mg may be potentially mislabeled as ATORVASTATIN CALCIUM, Tablet, 40 mg, NDC 00378212177…
Reason Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Reason Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Reason Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Reason Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Reason Labeling: Not Elsewhere Classified; foil label on immediate blister pack indicates active ingredient as Chlorpheniramine rather than Diphenhydramine
Reason 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…
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