Class II · Moderate risk
Doxycycline Hyclate USP Tablets
Failed Dissolution Specifications: manufacturer West-Ward Pharm Corp. recalled these repackaged lots due to failed dissolution results.
FDA drug recalls in 2018
Every FDA drug recall initiated in 2018, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,681 recalls, newest first.
Class II · Moderate risk
PIO&METFORMIN 15/1000 mg Tab 1
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Class II · Moderate risk
Metformin Hydrochloride Extended Release Tablets 1000 mg
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Class II · Moderate risk
Metformin Hydrochloride Extended Release Tablets 1000 mg
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Class II · Moderate risk
Metformin Hydrochloride Extended Release Tablets
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Class II · Moderate risk
Fortamet (metformin HCl)
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Class II · Moderate risk
Paliperidone Extended Release Tablets 9 mg
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Class II · Moderate risk
Paliperidone Extended Release Tablets 3 mg
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Class I · High risk
Levothyroxine and Liothyronine
Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled.
Class I · High risk
Levothyroxine and Liothyronine
Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled.
Class I · High risk
Levothyroxine and Liothyronine
Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled.
Class I · High risk
Levothyroxine and Liothyronine
Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled.
Class I · High risk
Levothyroxine and Liothyronine
Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled.
Class III · Low risk
Acne Treatment Pads
Subpotent drug: The product active ingredient level not matching the exact levels indicated on the packaging label.
Class II · Moderate risk
Family Dollar Saline Nasal Spray 4.25 oz. can
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk
Finafta Baby
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk
Rexall
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk
Rexall
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk
Rexall
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk
Rhinall Nasal Decongestant Nasal Spray
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class I · High risk
Sinus Relief
Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Pseudomonas aeruginosa.
Class II · Moderate risk
CVS Health
Subpotent Drug: low out of specification assay results for the bacitracin zinc ingredient.
Class II · Moderate risk
Mushatt's No. 9
Microbial Contamination of Non-Sterile Products and Subpotent Drug: failure for microbiological growth exceeding specification and low out of specification assay results for salicylic acid.
Class II · Moderate risk
CeraVe Healing Lip Balm/SPF 30
Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Staphalococcus aureus.
Class III · Low risk
Cicatricure
Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients.