Class II · Moderate risk
Natural Pain Relieving Cream
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Ongoing drug recalls - open right now
Every FDA drug recall whose status is still Ongoing: the firm is still removing product from the market, or the FDA has not yet closed the file. Some were opened years ago and never formally terminated, so check the initiation date as well as the status.
2,760 recalls, newest first.
Class II · Moderate risk
Pain Wizard
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II · Moderate risk
Diltiazem Hydrochloride Extended-Release Capsules
Failed Dissolution Specifications
Class III · Low risk
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free
Out of specification for assay
Class II · Moderate risk
Class III · Low risk
Abilify (aripiprazole)
Cross Contamination with Other Products
Class III · Low risk
Abilify (aripiprazole)
Cross Contamination with Other Products
Class III · Low risk
Abilify (aripiprazole)
Cross Contamination with Other Products
Class III · Low risk
Abilify (aripiprazole)
Cross Contamination with Other Products
Class I · High risk
Sapropterin Dihydrochloride Powder for Oral Solution 100mg
Sub-potent Drug; powder discoloration associated with decreased potency
Class I · High risk
Javygtor (sapropterin dihydrochloride)
Sub-potent Drug; powder discoloration associated with decreased potency
Class II · Moderate risk
Isotretinoin Capsules
Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
Class II · Moderate risk
Diltiazem Hydrochloride Extended-Release Capsules
Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study.
Class I · High risk
Aruba Aloe Hand Sanitizer Gel
Chemical Contamination: Product manufactured with ethanol API that contains methanol
Class I · High risk
Alcoholada Gel
Chemical Contamination: Product manufactured with ethanol API that contains methanol
Class II · Moderate risk
fentaNYL Citrate 2
Lack of Assurance of Sterility: leaking bags
Class I · High risk
Honey Manuka Bunny Love
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class I · High risk
Alphastrip Male Performance Enhancer
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class I · High risk
The GOAT SUBLINGUAL STRIP
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class I · High risk
Silverback Xxx Power Male Enhancement
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class I · High risk
libigrow RED DRAGON+
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class I · High risk
GoHARD 25000
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class I · High risk
Pink Pussycat Honey
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class I · High risk
Samurai-X Honey 6800
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class I · High risk
Flower Power
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.