Class I · High risk
Atropine Sulfate 0.4 mg/ml Injection
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
FDA Drug Recalls
1,273 recalls, newest first
Class II · Moderate risk
Glycopyrrolate 0.2 mg/ml
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Class I · High risk
Midazolam HCl 1 mg/ml in 0.9% Sodium Chloride in 50 mL and 100 mL IV bag
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Class I · High risk
Midazolam HCl 2 mg/ml in 0.9% Sodium Chloride in 30 mL PVC Vial
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Class I · High risk
Marcaine (bupivacaine HCl)
Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution.
Class II · Moderate risk
0.9% Sodium Chloride Irrigation
Presence of Particulate Matter: Nylon fibers found in a bottle of 0.9% sodium chloride for irrigation.
Class III · Low risk
Olanzapine Orally Disintegrating Tablets 5 mg
Subpotent Drug: Out of specification (OOS) results at the 9 month temperature point.
Class I · High risk
1% LIDOCAINE HCl Injection
Presence of Particulate Matter: Confirmed customer complaint that orange and black particulates, identified as iron oxide, were found embedded within the glass vial and floating in solution.
Class III · Low risk
Triveen - PRx RNF Capsules
Labeling: Not Elsewhere Classified: Label indicates that the product contains Vitamin B12 (12 micrograms) on the Supplement Facts panel, however, the formulation of this product does not contain Vitamin B12.
Class I · High risk
CUBICIN (daptomycin for injection)
Presence of Particulate Matter: Customer complaint stating that one vial contained a glass shard.
Class III · Low risk
Wockhardt Metoprolol Succinate
Failed Dissolution Specifications: Product was out of specification (OOS) at the 12 month long term stability testing point.
Class II · Moderate risk
Pristiq (desvenlafaxine)
Presence of Foreign Tablets/Capsules: Pfizer is recalling 50 mg Pristiq (desvenlafaxine) extended release tablets because a single Pristiq 100 mg tablet was found in a bottle of 50 mg Pristiq.
Class I · High risk
Super ARTHGOLD 500mg
Marketed Without an Approved NDA/ANDA; Product contains undeclared indomethacin, diclofenac, and chlorzoxazone.
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 II · Moderate risk
LOSARTAN POTASSIUM Tablets
Presence of Foreign Substance; some bottles may contain debris that was swept up during cleaning
Class II · Moderate risk
phosLo (calcium acetate)
Cross Contamination with Other Products: Potential for contaminant on the cotton packaging inside the bottle. Chemical analysis of the contaminant found on the cotton was identified as a formulation of 4% Trimipramine methanesulfonate - a tricyclic antidepressant..
Class III · Low risk
Oxandrolone Tablets
Labeling: Missing Label; Three cases of product (total of 36 bottles) were packaged without the primary label on the bottle. The cases were, however, packaged in the correct finished product shipper, labeled with the correct shipper bar code label, sealed with tamper-evident tape and erroneously shipped to Upsher-Smith.
Class III · Low risk
Day Time Cold & Flu
Subpotent Drug: Phenylephrine component is subpotent.
Class III · Low risk
Haloperidol Decanoate Injection
Failed Impurities/Degradation Specifications: Fresenius Kabi is recalling three lots of Haloperidol Decanoate Injection due to an out-of-specification result.
Class III · Low risk
Maximum Strength/Non-Drowsy Tussin DM Adult Maximum Strength
Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles.
Class II · Moderate risk
Sodium Chloride Hypertonicity Ophthalmic Ointment
Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye.
Class II · Moderate risk
Muro 128 (sodium chloride)
Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye.
Class II · Moderate risk
Metoprolol Succinate Extended-Release Tablets
Failed Dissolution Specifications: Failure of dissolution test observed at three month time point.
Class I · High risk
Thinogenics
Marketed Without an Approved NDA/ANDA: Product contains undeclared sibutramine.
Class II · Moderate risk
Gemcitabine For Injection USP
Lack of Assurance of Sterility: A particle excursion for a different batch of the same product may lead to a lack of sterility assurance.