Class III · Low risk
Betamethasone Dipropionate Ointment USP
Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
FDA drug recalls in 2021
Every FDA drug recall initiated in 2021, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,152 recalls, newest first.
Class III · Low risk
Betamethasone Dipropionate Ointment USP
Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
Class III · Low risk
Betamethasone Dipropionate Ointment USP
Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
Class I · High risk
Enoxaparin Sodium Injection
Labeling; Label Mixup; syringe barrels may contain markings for 100 mg/mL (corresponding to 100 mg/mL strength) instead of 150 mg/mL (corresponding to 120 mg/0.8mL strength)
Class I · High risk
Enoxaparin Sodium Injection
Labeling; Label Mixup; syringe barrels may containing markings for 150 mg/mL (corresponding to 120 mg/0.8mL strength) instead of 100 mg/mL markings (corresponding to 100 mg/mL strength)
Class II · Moderate risk
Scott¿ Moisturizing Foam Hand Sanitizer
Labeling; Label Mix-up; some bottles containing Foam Skin Cleanser soap are incorrectly labeled as Moisturizing Foam Hand Sanitizer
Class III · Low risk
Auryxia (ferric citrate)
Failed Dissolution Specifications
Class III · Low risk
Glycopyrrolate Injection
Labeling; Label Mix-up; correctly labeled 2 mL vials were packaged into blister strips labeled for 1 mL vials
Class II · Moderate risk
Spironolactone Tablets
Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets.
Class I · High risk
Spironolactone Tablets
Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 25 mg may contain spironolactone 50 mg tablets.
Class I · High risk
Cisatracurium Besylate Injection
Labeling: Label mix-up: Carton of Cisatracurium Besylate Injection, USP was observed to contain ten vials mislabeled as Phenylephrine Hydrochloride Injection, USP, but confirmed to contain Cisatracurium
Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.
Class II · Moderate risk
Cephalexin for Oral Suspension
CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.
Class II · Moderate risk
Cephalexin for Oral Suspension
CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.
Class II · Moderate risk
Lidocaine/Tetracaine
Superpotent Drug. Lidocaine higher concentration than listed
Class III · Low risk
Oseltamivir Phosphate for Oral Suspension
Failed Impurities/Degradation Specifications; Out-of-specification test results observed for Impurity C at 9 month long-term stability time point.
Class II · Moderate risk
Famotidine Tablets USP 40mg
Presence of foreign tablets/capsules: Famotidine 20mg and ibuprofen 400mg tablets were found in a lot of famotidine 40mg.
Class I · High risk
Benzonatate capsules
Labeling: Label Mix-up: Bottle labeled as Benzonatate 100 mg capsules contained Benzphetamine 50 mg tablets and a bottle labeled as Benzphetamine 50 mg tablets contained Benzonatate 100 mg capsules.
Class III · Low risk
Benzphetamine tablets
Labeling: Label Mix-up: Bottle labeled as Benzonatate 100 mg capsules contained Benzphetamine 50 mg tablets and a bottle labeled as Benzphetamine 50 mg tablets contained Benzonatate 100 mg capsules.
Class III · Low risk
Testosterone Cypionate Injection
Incorrect Labeling: Incorrect lot number on secondary packaging
Class II · Moderate risk
Nortriptyline HCl Capsules
CGMP deviations.
Class III · Low risk
Phytonadione Tablets 5mg
Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.
Class III · Low risk
Mephyton (phytonadione)
Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.
Class II · Moderate risk
Nitrofurantoin Capsules USP
Failed Dissolution Specifications
Class II · Moderate risk
Sulfur Ointment 10%
Labeling: Label Mix-Up. THe English label with Drug Facts panel for Camphor was incorrectly placed on product.