Class II · Moderate risk Ongoing
Pantoprazole Sodium Delayed Release Tablets USP 40mg
Reason CGMP Deviations: Discoloration
FDA Drug Recalls
2,661 recalls, newest first
Class I · High risk Ongoing
Atovaquone Oral Suspension USP
Reason Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged product.
Class II · Moderate risk Ongoing
Daytrana
Reason Defective Delivery System: Out of specification for shear.
Class II · Moderate risk Ongoing
Daytrana
Reason Defective Delivery System: Out of specification for shear.
Class II · Moderate risk Ongoing
Daytrana
Reason Defective Delivery System: Out of specification for shear.
Class II · Moderate risk Ongoing
Daytrana
Reason Defective Delivery System: Out of specification for shear.
Class III · Low risk Ongoing
Mektovi
Reason 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 Ongoing
Delsam Pharma's Artificial Eye Ointment
Reason Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria.
Class II · Moderate risk Ongoing
NaturalCare
Reason CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Class II · Moderate risk Ongoing
NaturalCare bioAllers
Reason CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Class II · Moderate risk Ongoing
NatraBio
Reason CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Class II · Moderate risk Ongoing
NaturalCare bioAllers
Reason CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Class III · Low risk Ongoing
Evamist
Reason 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 Ongoing
Purely Soothing MSM Nasal Spray
Reason CGMP Deviations
Class I · High risk Ongoing
Purely Soothing 15% MSM Drops
Reason Non-Sterility
Class I · High risk Ongoing
Snowy Range Blue Alcohol Antiseptic 80% Topical Solution Hand…
Reason Chemical Contamination: FDA analysis found the product to contain methanol, acetaldehyde, and acetal above the limits.
Class II · Moderate risk Ongoing
Fentanyl 500mcg
Reason Lack of assurance of sterility: Suspected microbial growth present on external label packaging.
Class II · Moderate risk Ongoing
Tacrolimus Capsules
Reason 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 Ongoing
Delsam Pharma's ARTIFICIAL TEARS
Reason 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 Ongoing
Delsam Pharma's ARTIFICIAL TEARS
Reason Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
Class II · Moderate risk Ongoing
Artificial Tears
Reason 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 Ongoing
Artificial Tears
Reason Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
Class III · Low risk Ongoing
Atropine Sulfate Ophthalmic Solution
Reason Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.
Class II · Moderate risk Ongoing
Hand Sanitizer
Reason 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 Ongoing
Hand Sanitizer
Reason 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.