Class I · High risk
Fentanyl-Bupivacaine HCL Pf Injectable 3000mcg-12mg/Ml
Non-Sterility
FDA Drug Recalls
18,003 recalls, newest first
Class I · High risk
Bupivacaine Hcl-Lioresal Pf Injectable 7.5mg-1625mcg/Ml
Non-Sterility
Class I · High risk
Bupivacaine Hcl-Baclofen Pf Injectable 40mg-4000mcg/Ml
Non-Sterility
Class II · Moderate risk
Catapres (clonidine hydrochloride, USP)
An extraneous peak was observed for dissolution testing.
Class II · Moderate risk
Catapres (clonidine hydrochloride, USP)
An extraneous peak was observed for dissolution testing.
Class II · Moderate risk
Catapres (clonidine hydrochloride, USP)
An extraneous peak was observed for dissolution testing.
Class II · Moderate risk
Time-Cap Labs
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk
Time-Cap Labs
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk
Chlorhexidine Gluconate 20% 0012 Medichem
Discoloration.
Class III · Low risk
Candesartan Cilexetil and Hydrochlorothiazide Tablets
Out-of-specification organic impurity results obtained during routine stability testing.
Class I · High risk
Smart Care HAND SANITIZER
Labeling: Not Elsewhere Classified. Container packaging is made, formed or filled to be misleading, resembling food and drink pouches
Class III · Low risk
Fluocinonide Ointment USP 0.05%
Failed Impurities/Degradation - Out-of-specification results for Fluocinolone Acetonide impurity.
Class I · High risk
Goldenseal POWDER
Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii.
Class I · High risk
Cord Care POWDER
Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii.
Class I · High risk
Happy Ducts Compress
Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii.
Class III · Low risk
Nystatin Oral Suspension
Failed Impurties/Degradation Specifications: out of specification results for an impurity for one lot
Class III · Low risk
Metformin Hydrochloride Tablets USP
Presence of Foreign Tablets/Capsules: Metformin 1000mg with different imprint was found in bottles.
Class II · Moderate risk
SYP Health Hand Sanitizer Alcohol Gel
CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
Class III · Low risk
Cystaran (cysteamine ophthalmic solution)
Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl.
Class II · Moderate risk
RIOMET ER (metformin hydrochloride for extended-release oral suspension)
CGMP Deviations: Detection of N-nitrosodimethylamine (NDMA) impurity in finished drug product.
Class III · Low risk
Homeopathic Energy Catalyst
Labeling: Product Contains Undeclared API; Incorrect formulation
Class I · High risk
NP Thyroid 120
Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levothyroxine (T4) portion of the product.
Class I · High risk
NP Thyroid 15
Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levothyroxine (T4) portion of the product.
Class II · Moderate risk
Nature-Throid 1 GR
CGMP deviations; repackaged product was recalled by the manufacturer because it was manufactured under the same conditions as products found to be sub-potent.
Class III · Low risk
Nymalize (nimodipine)
Subpotent Drug