Class III · Low risk
HCG-Vitamin B12 5000 IU-8 mg in 10 mL vial
Labeling; Error on Declared Strength; product description incorrectly states HCG 7500 units instead of 5000 units. The primary panel is correct
Class III drug recalls - low risk
Class III means the product is unlikely to cause harm but violates FDA labeling or manufacturing rules. These are the recalls you rarely hear about; pharmacies usually just swap the affected lot.
1,716 recalls, newest first.
Class III · Low risk
Testosterone Cypionate 200 mg/mL in Sesame Oil
Incorrect/Undeclared Excipient; product description section of testosterone cypionate incorrectly states "in grapeseed oil" instead of "in sesame oil" . The primary panel is correct
Class III · Low risk
NIFEdipine Capsules USP
Presence of Foreign Tablets/Capsules
Class III · Low risk
Paricalcitol Capsules
Failed Impurities/Degradation Specifications: This repackaged product was recalled by its manufacturer due to failed results for impurities.
Class III · Low risk
Clonazepam Tablets
Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 16 month timepoint.
Class III · Low risk
Clonazepam Tablets
Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 15 month timepoint.
Class III · Low risk
Gildess 24 FE 1.5/30
Subpotent Drug; Ethinyl Estradiol
Class III · Low risk
Gildess FE 1.5/30
Subpotent Drug; Ethinyl Estradiol
Class III · Low risk
Gildess FE 1/20
Subpotent Drug; Ethinyl Estradiol
Class III · Low risk
Gildess 1/20
Subpotent Drug; Ethinyl Estradiol
Class III · Low risk
Gildess 1.5/30
Subpotent Drug; Ethinyl Estradiol
Class III · Low risk
PARICALCITOL Capsules
Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.
Class III · Low risk
PARICALCITOL Capsules
Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.
Class III · Low risk
PARICALCITOL Capsules
Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.
Class III · Low risk
Estradiol 12.5 mg Pellet
Superpotent and Subpotent drugs
Class III · Low risk
Estradiol 3 mg Pellet
Superpotent and Subpotent drugs
Class III · Low risk
Testosterone 12.5 mg Pellet
Superpotent and Subpotent drugs
Class III · Low risk
Testosterone Cholesterol
Superpotent and Subpotent drugs
Class III · Low risk
PREMARIN (conjugated estrogen tablets, USP)
Labeling: Incorrect or Missing Lot and/or Exp Date: Bottles were incorrectly labeled with an expiry date of 11/17; the correct date is 09/17.
Class III · Low risk
Xanax (Alprazolam)
Labeling: Missing Label-Primary packaging label (i.e. blister card) is blank and contains no product information (e.g. product name, strength, lot number, expiry).
Class III · Low risk
mitoXANTRONE Injection USP
Failed Impurities/Degradation Specifications: potential failure to meet the specification for Impurity D throughout shelf-life.
Class III · Low risk
buPROPion Hydrochloride Extended-release Tablets
Failed Dissolution Specifications
Class III · Low risk
Cytotec (misoprostol)
Failed Impurities/Degradations Specifications; Out of specification results for two known degradation products and total impurities at 18 months
Class III · Low risk
Lansoprazole Delayed-Release Capsules
Labeling: Label mix-up. The inner packaging was properly labeled Omeprazole DR 40mg Capsules, but the outer secondary packaging was mislabeled Lansoprazole Delayed-Release 30mg Capsules.
Class III · Low risk
Varithena (polidocanol injectable foam)
Defective Delivery System: Incorrect type of syringe found in commercially distributed administration pack