Class III · Low risk
Finasteride Tablets
Failed Tablet/Capsule Specification: Tablets were found to be twice the thickness in one lot of product.
FDA drug recalls in 2016
Every FDA drug recall initiated in 2016, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,199 recalls, newest first.
- Total recalls
- 1,199
- Class I (high risk)
- 63
- Currently ongoing
- 90
- Most recent
- Dec 29, 2016
Class II · Moderate risk
Flucanozole Tablets
Failed Dissolution Specifications; 18 month stability time point
Class II · Moderate risk
Flucanozole Tablets
Failed Dissolution Specifications; 18 month stability time point
Class II · Moderate risk
Flucanozole Tablets
Failed Dissolution Specifications; 18 month stability time point
Class II · Moderate risk
Flucanozole Tablets
Failed Dissolution Specifications; 18 month stability time point
Class II · Moderate risk
Clindamycin Phosphate and Benzoyl Peroxide Gel
Microbial Contamination of Non-Sterile Product; small number of tubes may include the presence of mold on the cap
Class III · Low risk
Aripiprazole Tablets
Superpotent Drug; out of specification results for assay (manufacturer)
Class II · Moderate risk
Venlafaxine Hydrochloride extended release capsules
Failed Tablet/Capsule Specifications: Some bottles contain punctured, and/or clumped/melted capsules.
Class II · Moderate risk
Furosemide Tablets USP
Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint.
Class III · Low risk
Temazepam Capsules USP
Failed Stability Specifications
Class II · Moderate risk
Nadolol Tablets
Failed dissolution specification: recalled due to an out of specification dissolution result of 40% (Specification: NLT 80%)
Class II · Moderate risk
Amoxicillin for Oral Suspension USP
Subpotency: due to a low, out of specification test result for assay during stability testing.
Class II · Moderate risk
Lisinopril tablets
Failed tablet/capsule specification: missing break line on the 5mg tablet.
Class III · Low risk
buPROPion Hydrochloride Extended-release Tablets
Failed Dissolution Specifications; 18 month stability time point
Class III · Low risk
buPROPion Hydrochloride Extended-release Tablets
Failed Dissolution Specifications; 18 month stability time point
Class II · Moderate risk
Temozolomide Capsules
Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
Class II · Moderate risk
Temozolomide Capsules
Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
Class II · Moderate risk
Temozolomide Capsules
Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
Class II · Moderate risk
Temozolomide Capsules
Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
Class III · Low risk
Aripiprazole Tablets
Superpotent Drug: Product may not meet specifications throughout shelf life.
Class III · Low risk
Pantoprazole Sodium for Injection
Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance.
Class II · Moderate risk
Midazolam Injection
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Gentell Hydrogel Wound Dressing REGULAR
CGMP Deviations
Class II · Moderate risk
Gentell Hydrogel Ag Saturated Gauze
CGMP Deviations
Class II · Moderate risk
Phenylephrine 2.5% + Tropicamide 1% Compounded Eye Drops Solution
Lack of Sterility Assurance