Class I · High risk
Levetiracetam Oral Solution 100mg/mL
Microbial Contamination of Non-sterile Products: Out-of-specification results obtained for Total Aerobic Microbial Count.
FDA Drug Recalls
103 recalls, newest first
Class II · Moderate risk
LETS GEL KIT Convenience Pack
Microbial contamination of non-sterile product.
Class II · Moderate risk
DrKids Himasal Natural Nasal Saline Solution
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk
DrKids Children's Natural Cough Syrup English Ivy Leaf
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk
Major Infants' Gas Relief Drops
Microbial Contamination of Non-Sterile Product.
Class I · High risk
Milk of Magnesia USP
Microbial Contamination of Non-Sterile Products: product failed bioburden testing for Total Aerobic Microbial Count.
Class II · Moderate risk
RELPAX (eletriptan HBr)
Microbial Contamination of Non-Sterile Products: contamination with Burkholderia and Pseudomonas.
Class II · Moderate risk
PRE-TAT (lidocaine)
Microbial Contamination of Non-Sterile Products: products were found to be contaminated and above specification for lidocaine assay.
Class II · Moderate risk
PRE-TAT (lidocaine)
Microbial Contamination of Non-Sterile Products: products were found to be contaminated and above specification for lidocaine assay.
Class II · Moderate risk
MONSEL'S (Ferric Subsulfate)
Microbial Contamination of Non-Sterile Products and Superpotent Drug: FDA analysis revealed microbial contamination in addition to high out of specification results for iron content.
Class II · Moderate risk
Clobazam Oral Suspension
Microbial Contamination of Non-Sterile Products: Out-of-specification results for Microbial Enumeration Tests USP <61> was observed.
Class II · Moderate risk
CVS Health Children's Nasal Saline Drops with Himalayan Salt Saline Nasal Moisturizer
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk
DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistamine
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk
CVS Health Children's Allergy Relief Liquid Medication…
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk
CRYO-273 Cold Pain Relieving Gel 128 FL. OZ. Distributed By: CRYO-273.com Tampa
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Class II · Moderate risk
Wonder Freeze Pain Releiving Gel with ILEX
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Class II · Moderate risk
Kool Comfort Cooling Pain Relief
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Class II · Moderate risk
Cool Hot Ice Analgesic Gel
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Class II · Moderate risk
CRYO-273 Cold Pain Relieving Gel Roll-On 3 FL. OZ.
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Class II · Moderate risk
CVS Health Glycerin Suppositories
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Class II · Moderate risk
Soothe&Cool Protect Moisture Guard Skin Protectant
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Class II · Moderate risk
Hydrocortisone Cream
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Class II · Moderate risk
Hydrocortisone Cream
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Class II · Moderate risk
Hydrocortisone Cream With Aloe
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Class II · Moderate risk
Hydrocortisone Cream With Aloe
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.