Class II · Moderate risk
Ambi 25dph/7.5peh
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
Ambi 20dm100gfn10peh
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
Ambi 15dm/100gfn/5peh
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
Lansoprazole Delayed-release Capsules
Presence of Foreign Tablets/Capsules: Bottles of lansoprazole 30 mg delayed-release capsules may contain topiramate 100 mg tablets.
Class III · Low risk
Methocarbamol 750 mg Tablets
Labeling: Incorrect or missing lot and/or expiration date. The product was mistakenly labeled with an expiration date of 10/16 instead of 01/16.
Class I · High risk
Lactated Ringer's and 5% Dextrose Injection
Non-Sterility: Confirmed customer complaint of product contaminated with mold.
Class III · Low risk
Sodium Sulfacetamide 10% and Sulfur 5% Lotion
Superpotent: Drug product active ingredients were formulated incorrectly (too high) with respect to the label strength.
Class II · Moderate risk
Terazosin Hydrochloride Capsules
Presence of Foreign Tablets/Capsules: Recall is being conducted due to a foreign capsule found in one bottle.
Class III · Low risk
Crest PRO-HEALTH CPC Antigingivitis/Antiplaque Oral Rinse
Cross Contamination with Other Products: Product was mixed with another type of mouth wash.
Class II · Moderate risk
Irinotecan Hydrochloride Injection
Crystallization: Active pharmaceutical ingredient is precipitating in product solution.
Class II · Moderate risk
Medi-bolic Booster Injectable
CGMP Deviations: Pharmaceutical for injection was not manufactured according to Good Manufacturing Procedures.
Class III · Low risk
Syeda (drospirenone and ethinyl estradiol)
Tablet/Capsule Imprinted with Wrong ID; a portion of the tablets could contain the incorrect debossing on one side of the tablet U2 instead of U3.
Class III · Low risk
Wal-Mart Equate Tussin CF Adult Maximum Strength
Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.
Class III · Low risk
Select Brand Cough Control CF Max
Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.
Class III · Low risk
Rite Aid Maximum Strength Tussin Cough & Cold Mucus Relief CF
Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.
Class III · Low risk
Well at Walgreens Wal-Tussin CF Max
Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.
Class II · Moderate risk
Mercuroclear Antiseptic Anesthetic First Aid Helps prevent…
Microbial Contamination of Non-Sterile Product(s): The product has the potential to be contaminated with Bulkholderia gladioli.
Class III · Low risk
Ventavis (iloprost)
Subpotent Drug: OOS (out of specification) assay result at the 12 month stability time point.
Class II · Moderate risk
Carvedilol Tablets
Failed Tablet/Capsule Specifications: Product exceeds specification for tablet weight and tablet thickness.
Class III · Low risk
PULMICORT RESPULES 0.5 mg/2 ml
Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.
Class III · Low risk
PULMICORT RESPULES 0.25 mg/2 ml Budesonide Inhalation Suspension
Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.
Class II · Moderate risk
Furosemide Injection USP
Lack of Assurance of Sterility; possible loose crimp applied to fliptop vial
Class II · Moderate risk
0.9% Sodium Chloride Injection USP
Lack of Assurance of Sterility: There is the potential for solution to leak from the administrative port to the fill tube seal.
Class II · Moderate risk
Belladonna Alkaloids
Presence of Foreign Substance: Uncharacteristic blacks spots were found in tablets.
Class III · Low risk
Glycopyrrolate Tablets
Subpotent Drug