Class III · Low risk
Sodium Sulfacetamide
Subpotency: one product for active ingredient assay and another one for preservative assay
FDA Drug Recalls
14,806 recalls, newest first
Class I · High risk
Avicel RC-591 NF
Microbial Contamination of Non-Sterile Product: Out-of-specification results obtained for total aerobic microbial count (TAMC).
Class II · Moderate risk
Arformoterol Tartrate Inhalation Solution 15 mcg*/2 mL For Oral…
Lack of Assurance of Sterility
Class II · Moderate risk
Class II · Moderate risk
Zonisamide Capsules USP 50 mg 100 Capsules Rx Only NDC…
CGMP Deviations
Class II · Moderate risk
Chlorzoxazone Tablets USP 750 mg 100 Tablets Rx Only NDC…
CGMP Deviations
Class II · Moderate risk
Chlorzoxazone Tablets USP 375 mg 100 Tablets Rx Only NDC…
CGMP Deviations
Class II · Moderate risk
Naproxen Sodium Tablets
CGMP Deviations
Class II · Moderate risk
Naproxen Sodium Tablets
CGMP Deviations
Class II · Moderate risk
Fulvestrant Injection 250 mg/5 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Betadine Solution Swabstick Povidone-Iodine Solution USP
Subpotent Drug
Class II · Moderate risk
Rompe Pecho Max Multi-Symptoms Maximum Strength
Microbial Contamination of Non-Sterile Products
Class II · Moderate risk
Rompe Pecho Ex Expectorant
Microbial Contamination of Non-Sterile Products
Class II · Moderate risk
Rompe Pecho DM
Microbial Contamination of Non-Sterile Products
Class II · Moderate risk
Rompe Pecho CF Cold & Flu Advanced Formula
Microbial Contamination of Non-Sterile Products
Class I · High risk
Firvanq (vancomycin hydrochloride for oral solution)
Product Mix-up: Incorrect diluent component included in the kit.
Class II · Moderate risk
Lyrica CR (pregabalin)
Failed Dissolution Specifications
Class II · Moderate risk
Betamethasone Dipropionate Lotion USP
Failed Stability Specifications: lot did not meet specification for the Active Pharmaceutical Ingredient (API) particle test, which was determined through routine stability testing
Class II · Moderate risk
Aconitum Napellus 12X Fear* 87% Alcohol HPUS: packaged in 30 mL containers
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk
Aconitum nap Fear* 20% Alcohol HPUS: 6X
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk
Aconitum Napellus Fear* Sucrose/Lactose Pills HPUS: 8X
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk
Aconitum nap Fear* Sucrose/Lactose Pills HPUS: 4X
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk
Aconitum Napellus Fear* 20% Alcohol HPUS: 5X
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk
Strophanthus hisp 30X
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk
Strophanthus hisp 30X
Out-of-specification test results obtained for identification testing based on HPTLC analysis.