Class III · Low risk
Sirolimus Tablets 1 mg
Failed Impurities/Degradation Specifications
FDA Drug Recalls
1,058 recalls, newest first
Class I · High risk
C-Progesterone Oil 100 Mg/Ml
Non-Sterility
Class I · High risk
Poseidon Platinum 3500 capsule
Marketed Without An Approved NDA/ANDA: Product found to contain undeclared sildenafil and tadalafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.
Class II · Moderate risk
Advance Hand Sanitizer
CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same conditions as the product lots found to contain methanol.
Class II · Moderate risk
ProtectoRx
CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same conditions as the product lots found to contain methanol.
Class II · Moderate risk
DiBAR LABS Hand Sanitizer
CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same conditions as the product lots found to contain methanol.
Class I · High risk
DiBAR LABS Hand Sanitizer
Chemical Contamination: FDA analysis found 3 lots of DiBAR hand Sanitizer to be below the label claim for ethanol content and to contain methanol.
Class III · Low risk
Cequa (cyclosporine ophthalmic solution)
Subpotent and Presence of Particulates .
Class II · Moderate risk
Micardis Tablets
Subpotent Drug
Class III · Low risk
Atorvastatin Calcium Tablets
Failed Impurities -Degradation Specifications:due to presence of ATV cyclo IP and FP impurities
Class II · Moderate risk
Metformin HCl Extended-Release Tablets
Presence of foreign substance: identified as activated carbon.
Class I · High risk
1% Lidocaine HCl Injection
Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USP
Class I · High risk
0.5% Bupivacaine Hydrochloride Injection
Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USP
Class III · Low risk
Thiamine HCl Injection
Labeling: Incorrect or Missing Lot and/or Exp Date: Cartons with the correct lot number 200906 contain vials labeled with the incorrect lot number 200901.
Class II · Moderate risk
Sterile Water for Inj.
Presence of Particulate Matter: particulate matter identified as an insect in one vial.
Class I · High risk
NP Thyroid 120 Thyroid Tablets
Subpotent Drug
Class I · High risk
NP Thyroid 90 Thyroid Tablets
Subpotent Drug
Class I · High risk
NP Thyroid 60 Thyroid Tablets
Subpotent Drug
Class I · High risk
NP Thyroid 30 Thyroid Tablets
Subpotent Drug
Class I · High risk
NP Thyroid 15 Thyroid Tablets
Subpotent Drug
Class III · Low risk
Olmesartan Medoxomil Tablets
Presence of Foreign Tablet/Capsule
Class II · Moderate risk
Cefixime for Oral Suspension USP 100 mg/5mL
Subpotent Drug
Class III · Low risk
DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose
Temperature Abuse: Product exposed to temperature outside specified limits.
Class III · Low risk
DELFLEX Peritoneal Dialysis Solution with 4.25% Dextrose
Temperature Abuse: Product exposed to temperature outside specified limits.
Class III · Low risk
DELFLEX Peritoneal Dialysis Solution with 2.5% Dextrose
Temperature Abuse: Product exposed to temperature outside specified limits.