Class III · Low risk
Carbamazepine Oral Suspension USP
Subpotent Drug: low out of specification results.
FDA Drug Recalls
1,525 recalls · Class III, newest first
Class III · Low risk
Mobic (meloxicam)
Labeling: Incorrect or missing package insert. One lot of Mobic Tablets is packaged with an incorrect insert.
Class III · Low risk
Fluocinonide Gel USP
Cross contamination with other products: traces of Dapsone were found in the finished product.
Class III · Low risk
Equate Beauty Clarifying Face Daily Moisturizer 4 fl. oz.
Failed Stability Specifications
Class III · Low risk
Magnesium Citrate Oral Solution Cherry Flavor
Failed Impurities/Degradation Specifications.
Class III · Low risk
Magnesium Citrate Oral Solution Lemon Flavor
Failed Impurities/Degradation Specifications.
Class III · Low risk
AndroGel (testosterone gel)
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
Class III · Low risk
AndroGel (testosterone gel)
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
Class III · Low risk
Phentermine
Failed Impurities/Degradation Specification; out-of-specification results for individual unknown impurities at the 30 month Room Temperature Retained Sample stability test
Class III · Low risk
ENALAPRIL MALEATE Tablets
Failed Impurities/Degradation Specifications: manufacturer of product recalled this repackaged lot due to out of specification results for related compound.
Class III · Low risk
Enalapril Maleate Tablets
Failed Stability Specifications
Class III · Low risk
Propafenone Hydrochloride tablets
Failed moisture limits: Out of specification for moisture content.
Class III · Low risk
Enalapril Maleate tablets
Failed Impurities/Degradation Specifications: 5mg strength being recalled for out of specification results for related compound.
Class III · Low risk
Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL
Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substance instead of Class II controlled substance
Class III · Low risk
Phentermine Capsules
Failed Impurities/Degradation Specifications:Out of specification results for individual unknown impurities at 30th month Room Temperature Retained Sample stabilities test .
Class III · Low risk
Quillivant XR methylphenidate HCl
Failed Dissolution Specifications
Class III · Low risk
Quillivant XR methylphenidate HCl
Failed Dissolution Specifications
Class III · Low risk
Phentermine HCL Capsules
Failed Impurities/Degradation Specifications: out-of-specification results obtained for individual unknown impurities found at 30 month Room Temperature Retained Sample stability test.
Class III · Low risk
Glipizide Extended-Release Tablets
Failed Moisture Limits: out of specification test results for water content obtained during stability testing.
Class III · Low risk
Albuterol Sulfate Inhalation Solution
Failed Impurities/Degradation Specifications: high out of specification results for related compound D.
Class III · Low risk
Voriconazole Tablets
Failed impurities/degradation specifications: Out of specification for a related compound C.
Class III · Low risk
Make Up Perfect terra
Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Class III · Low risk
Make Up Perfect dark tan
Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Class III · Low risk
Make Up Perfect sand
Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Class III · Low risk
Make Up Perfect pastel
Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.