Class I · High risk
Atovaquone Oral Suspension USP
Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged product.
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
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of specification for shear.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of specification for shear.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of specification for shear.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of specification for shear.
Class III · Low risk
MEKTOVI (binimetinib)
Labeling: Incorrect or Missing Lot and/or Exp Date: The carton and bottle labels state an expiry date of March 2026; the correct expiration date is February 2025.
Class I · High risk
Delsam Pharma's Artificial Eye Ointment
Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria.
Class II · Moderate risk
NaturalCare
CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Class II · Moderate risk
NaturalCare bioAllers
CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Class II · Moderate risk
NatraBio
CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Class II · Moderate risk
NaturalCare bioAllers
CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Class III · Low risk
Evamist (estradiol transdermal spray)
Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Standard Deviation did not meet the requirement at the 18-month stability time point.
Class II · Moderate risk
Purely Soothing MSM Nasal Spray
CGMP Deviations
Class I · High risk
Purely Soothing 15% MSM Drops
Non-Sterility
Class I · High risk
Snowy Range Blue Alcohol Antiseptic 80% Topical Solution Hand…
Chemical Contamination: FDA analysis found the product to contain methanol, acetaldehyde, and acetal above the limits.
Class II · Moderate risk
Fentanyl 500mcg
Lack of assurance of sterility: Suspected microbial growth present on external label packaging.
Class II · Moderate risk
Tacrolimus Capsules
Presence of Foreign Tablets/Capsules: Presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containing and labeled as Tacrolimus 0.5 mg capsules.
Class II · Moderate risk
Delsam Pharma's ARTIFICIAL TEARS
CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same conditions as the lots found to be contaminated.
Class I · High risk
Delsam Pharma's ARTIFICIAL TEARS
Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
Class II · Moderate risk
Artificial Tears
CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same conditions as the lots found to be contaminated.
Class I · High risk
Artificial Tears
Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
Class III · Low risk
Atropine Sulfate Ophthalmic Solution
Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.
Class II · Moderate risk
Hand Sanitizer
CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer product, produced under temporary approval, into the market after March 31, 2022.
Class II · Moderate risk
Hand Sanitizer
CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer product, produced under temporary approval, into the market after March 31, 2022.
Class II · Moderate risk
Humatrix Microclysmic Gel
CGMP Deviations: initiated due to violations of CGMP manufacturing practices