Class II · Moderate risk
Papaverine/Phentolamine/PGE-1 Injectable
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
FDA drug recalls in 2015
Every FDA drug recall initiated in 2015, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,733 recalls, newest first.
Class II · Moderate risk
Cyanocobalamin 500 mcg/mL Injectable
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
Class I · High risk
PYROLA Advanced Joint Formula capsules
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared diclofenac, a prescription non-steroidal anti-inflammatory drug, and chlorpheniramine, an over-the-counter antihistimine, making this an unapproved drug.
Class II · Moderate risk
OXYCODONE HCl C-II Tablets
Superpotent Drug: Confirmed customer complaint of a single unit dose blister cavity containing 2 OXYCODONE HCl 5 mg tablets.
Class II · Moderate risk
NEXIUM¿ (esomeprazole magnesium)
Presence of Foreign Tablets/Capsules: Confimed customer compliant by a retail pharmacist that an unopened bottle labeled as NEXIUM¿ capsules contained 60 SEROQUEL¿ XR tablets.
Class II · Moderate risk
Trypan Blue 0.3%
Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vials.
Class II · Moderate risk
Brilliant Blue G BBG
Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vials.
Class II · Moderate risk
Methylcobalamin 5
Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vials.
Class II · Moderate risk
Human Chorionic Gonadotropic
Penicillin Cross Contamination: potentially contaminated with penicillin
Class II · Moderate risk
Human Chorionic Gonadotropic
Penicillin Cross Contamination: potentially contaminated with penicillin
Class II · Moderate risk
METHYLFOLATE Injection
Penicillin Cross Contamination: potentially contaminated with penicillin
Class II · Moderate risk
METHYLFOLATE Capsules
Penicillin Cross Contamination: potentially contaminated with penicillin
Class II · Moderate risk
TRI-EST Gels
Penicillin Cross Contamination: potentially contaminated with penicillin
Class II · Moderate risk
TRI-EST Liquids
Penicillin Cross Contamination: potentially contaminated with penicillin
Class II · Moderate risk
TRI-EST Lozenges
Penicillin Cross Contamination: potentially contaminated with penicillin
Class II · Moderate risk
TRI-EST Capsules
Penicillin Cross Contamination: potentially contaminated with penicillin
Class II · Moderate risk
BI-EST Creams
Penicillin Cross Contamination: potentially contaminated with penicillin
Class II · Moderate risk
BI-EST Suspensions
Penicillin Cross Contamination: potentially contaminated with penicillin
Class II · Moderate risk
BI-EST Lozenges
Penicillin Cross Contamination: potentially contaminated with penicillin
Class II · Moderate risk
BI-EST Gels
Penicillin Cross Contamination: potentially contaminated with penicillin
Class II · Moderate risk
BI-EST Capsules
Penicillin Cross Contamination: potentially contaminated with penicillin
Class II · Moderate risk
ESTRIOL Gels
Penicillin Cross Contamination: potentially contaminated with penicillin
Class II · Moderate risk
ESTRIOL Creams
Penicillin Cross Contamination: potentially contaminated with penicillin
Class II · Moderate risk
ESTRIOL Face Creams
Penicillin Cross Contamination: potentially contaminated with penicillin
Class II · Moderate risk
ESTRIOL Vaginal Gels
Penicillin Cross Contamination: potentially contaminated with penicillin