Class II · Moderate risk
Triple Antibiotic Ointment
CGMP Deviations: products were stored outside the drug label specifications.
FDA drug recalls in 2022
Every FDA drug recall initiated in 2022, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,390 recalls, newest first.
Class II · Moderate risk
Telmisartan and Hydrochlorothiazide Tablets USP
Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .
Class II · Moderate risk
Telmisartan and Hydrochlorothiazide Tablets USP
Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .
Class III · Low risk
Juice Beauty
Failed Dissolution Specifications
Class III · Low risk
Juice Beauty
Failed Dissolution Specifications
Class II · Moderate risk
Testosterone Gel 1%
Superpotent Drug: Out of specification assay result was obtained during stability testing.
Class III · Low risk
Aspirin and Extended-Release Dipyridamole Capsules
Failed Tablet/Capsule Specification : Capsule breakage
Class II · Moderate risk
Desmopressin Acetate Tablets
CGMP Deviations
Class II · Moderate risk
Hydrogen Peroxide Topical Solution USP
Cross Contamination With Other Products: Product is cross contaminated with low levels of isopropyl alcohol.
Class II · Moderate risk
Launch Sequence Aphrodisia Capsules
Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims.
Class II · Moderate risk
Launch Sequence Euphoria Capsules
Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims.
Class II · Moderate risk
Launch Sequence Capsules
Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims.
Class I · High risk
Launch Sequence Aphrodisia Capsules
Marketed Without An Approved NDA/ANDA: Product found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Class I · High risk
Launch Sequence Euphoria Capsules
Marketed Without An Approved NDA/ANDA: Product found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Class I · High risk
Launch Sequence Capsules
Marketed Without An Approved NDA/ANDA: Product found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Class II · Moderate risk
Divalproex Sodium Delayed-Release Tablets
Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.
Class I · High risk
Nifedipine WSP 0.2% Ointment
Subpotent and Superpotent Drug
Class II · Moderate risk
Hydrogen Peroxide Topical Solution
Labeling: Label Mix-Up-The primary label on the front of the bottles have Hydrogen Peroxide affixed to the front and back of the containers. However, the product inside the bottle is 70% Isopropyl Alcohol.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Customer complaints received for ripping patches and tight release/adhesive transfer.
Class II · Moderate risk
VICKS DAYQUIL NYQUIL LIQ COMB PK 6 FLOZ distributed to specific…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
QP COUGH COLD TABLET 16 CT distributed to specific Family Dollar…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
MUCINEX SE MAX STRENGTH 7CT distributed to specific Family Dollar…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
QP COLD MULTI SYMPTM DAY NITE CPLT 24 CT distributed to specific…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
HYLANDS 4KIDS COLD N MUCUS RELIEF 4 FL OZ distributed to specific…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
MUCINEX FASTMAX CAPLETS COLD FLU 4CT distributed to specific…
CGMP Deviations: product held outside appropriate storage temperature conditions.