Class III · Low risk
Maalox Extra Strength Antacid with Anti-Gas
Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.
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
Mavik¿ trandolapril tablets 4mg
Labeling: Incorrect Package Insert; product packaged with outdated version of the insert
Class III · Low risk
BuPROPion Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications: Dissolution test results at 8 hour time-point were above approved specification limits.
Class III · Low risk
Clobetasol Propionate Cream
Labeling: Label Mix-up; some cartons labeled as Clobetasol Propionate Cream USP contain tubes labeled as Clobetasol Propionate Gel USP. The actual product in the tube is Clobetasol Propionate Cream USP
Class III · Low risk
Tagitol V Barium Sulfate Suspension
Failed Stability Specifications: Tagitol V Barium Sulfate Lot #65846 sampled at 10 months exhibited results above the upper specification for viscosity.
Class III · Low risk
Oxycodone and Acetaminophen Capsules
Subpotent drug: Two lots of Oxycodone and Acetaminophen Capsules, USP 5/500 mg are being recalled due to low out of specification (OOS) assay result obtained at expiry (24 months) for the oxycodone portion of the product.
Class III · Low risk
Tums
Presence of Foreign Tablets/Capsules: Product labeled TUMS Ultra Assorted Berries 1000mg Chewable tables, may contain EX TUMS Assorted Berries 750mg tablets
Class III · Low risk
Alcohol Free Antiseptic
Microbial Contamination of Non-Sterile Products: This product is being recalled because a stability sample was found to be contaminated with Burkholderia contaminans.
Class III · Low risk
Braintree HalfLytely and Bisacodyl Tablet Bowel Prep Kit
Defective Container; Small micro fracture observed in the 2-Liter bottle at the fill line resulting in a small leak when patient reconstitutes the bulk powder
Class III · Low risk
Nata Komplete
Subpotent; Beta carotene (Vitamin A)
Class III · Low risk
Duet DHA 430 ec
Subpotent; Beta carotene (Vitamin A)
Class III · Low risk
Duet DHA 430
Subpotent; Beta carotene (Vitamin A)
Class III · Low risk
NataChew
Subpotent; Beta carotene (Vitamin A)
Class III · Low risk
Duet DHA 400 ec
Subpotent; Beta carotene (Vitamin A)
Class III · Low risk
Duet DHA 400
Subpotent; Beta carotene (Vitamin A)
Class III · Low risk
Duet DHA Balanced
Subpotent; Beta carotene (Vitamin A)
Class III · Low risk
LA MER the spf 18 fluid tint
Subpotent drug: Avobenzone 3%, one of the active sunscreen ingredients may be subpotent and sunscreen effectiveness may be less than labeled
Class III · Low risk
LA MER the spf 18 fluid tint
Subpotent Drug: Avobenzone 3%, one of the active sunscreen ingredients may be subpotent and sunscreen effectiveness may be less than labeled
Class III · Low risk
LA MER the spf 18 fluid tint
Subpotent Drug: Avobenzone 3%, one of the active sunscreen ingredients may be subpotent and sunscreen effectiveness may be less than labeled
Class III · Low risk
BFF's are COOL! Justice
Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.
Class III · Low risk
yum yum bubble gum Justice
Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.
Class III · Low risk
YOU CANT HANDLE THIS Justice
Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.
Class III · Low risk
I LOVE BACON Justice
Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.
Class III · Low risk
I MUSTACHE YOU TO BE MY BFF Justice
Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.
Class III · Low risk
GIRLS ROCK Justice
Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.