Class II · Moderate risk
Ondansetron HCI API
Microbial Contamination of Non-Sterile 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.
Class III · Low risk
Lansoprazole Delayed-Release Capsules
Labeling: Label mix-up. The inner packaging was properly labeled Omeprazole DR 40mg Capsules, but the outer secondary packaging was mislabeled Lansoprazole Delayed-Release 30mg Capsules.
Class I · High risk
GlucaGen HypoKit
Defective delivery system: detached needles on the syringe in the kit.
Class III · Low risk
Varithena (polidocanol injectable foam)
Defective Delivery System: Incorrect type of syringe found in commercially distributed administration pack
Class II · Moderate risk
Eye Wash
Lack of assurance of sterility
Class II · Moderate risk
Eye Wash
Lack of assurance of sterility
Class II · Moderate risk
Eye Irrigating Solution
Lack of assurance of sterility
Class I · High risk
Eye Wash
Non-Sterility: Direct evidence of contamination for 2 lots based on FDA samples.
Class I · High risk
Hyoscyamine Sulfate
Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
Class I · High risk
Hyoscyamine Sulfate
Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
Class I · High risk
Hyoscyamine Sulfate
Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
Class III · Low risk
Vyvanse (lisdexamfetamine dimesylate)
Presence of Foreign Tablets/Capsules
Class III · Low risk
Mozobil (plerixafor injection)
Labeling: Incorrect or Missing Package Insert
Class III · Low risk
Ramipril Capsules
Labeling: Incorrect or Missing Lot And/or Exp Date: Bottles labeled with the incorrect expiration date of 03/18 rather than 09/17.
Class III · Low risk
ZENATANE (isotretinoin capsules USP)
Failed Dissolution Specifications
Class II · Moderate risk
Phenylephrine HCI Injection
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.
Class II · Moderate risk
Ephedrine Sulfate Injection
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.
Class II · Moderate risk
Dextroamphetamine Saccharate
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Class II · Moderate risk
Dextroamphetamine Saccharate
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Class II · Moderate risk
Dextroamphetamine Saccharate
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Class II · Moderate risk
Dextroamphetamine Saccharate
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Class II · Moderate risk
Dextroamphetamine Saccharate
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Class II · Moderate risk
Dextroamphetamine Saccharate
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Class II · Moderate risk
Dextroamphetamine Saccharate
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Class II · Moderate risk
Dextroamphetamine Saccharate
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule