Class III · Low risk
Enalapril Maleate
Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
Class III drug recalls - low risk
Class III means the product is unlikely to cause harm but violates FDA labeling or manufacturing rules. These are the recalls you rarely hear about; pharmacies usually just swap the affected lot.
1,716 recalls, newest first.
Class III · Low risk
Enalapril Maleate Tablets
Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was recalled by the manufacturing firm, Wockhardt, due to out-of-specification results for the Enalapril DiKetopiperazine degradation product.
Class III · Low risk
Enalapril Maleate Tablets
Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was recalled by the manufacturing firm, Wockhardt, due to out-of-specification results for the Enalapril DiKetopiperazine degradation product.
Class III · Low risk
Enalapril Maleate Tablets USP
Failed Impurities/Degradation Specification; out-of-specification results for the Enalapril DKT degradant
Class III · Low risk
Enalapril Maleate Tablets USP
Failed Impurities/Degradation Specifications
Class III · Low risk
Enalapril Maleate Tablets USP
Failed Impurities/Degradation Specifications
Class III · Low risk
Rocaltrol (calcitriol)
Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
Class III · Low risk
Calcitriol Oral Solution
Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
Class III · Low risk
Equate ClearLAX
Labeling: Not Elsewhere Classified - A private label distributor noted unfiled NDC numbers on EQ ClearLax Polyethylene Glycol 3350 NF Powder Solution of various sizes.
Class III · Low risk
Atorvastatin Calcium Tablets
Failed Impurities/Degradation Specifications
Class III · Low risk
Atorvastatin Calcium Tablets
Failed Impurities/Degradation Specifications
Class III · Low risk
Atorvastatin Calcium Tablets
Failed Impurities/Degradation Specifications
Class III · Low risk
TESTOSTERONE 200 mg PELLET
Labeling: Incorrect or Missing Lot and/or Exp Date.
Class III · Low risk
ESTRADIOL 20mg PELLET
Labeling: Incorrect or Missing Lot and/or Exp Date.
Class III · Low risk
Maxzide-25
Superpotent Drug: Composite assay results obtained during routine stability testing were slightly above specification.
Class III · Low risk
Nystatin Oral Suspension
Resuspension problems: Out of specification for appearance and resuspendability.
Class III · Low risk
Valsartan Tablets USP
Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a larger size grade of excipient (Crospovidone).
Class III · Low risk
Hydrocodone Bitartrate and Acetaminophen Tablets
Labeling: Missing Label
Class III · Low risk
Zoma Shampoo
Subpotent
Class III · Low risk
T Shampoo For Hair and Body
Subpotent
Class III · Low risk
Lidocaine Patch 5%
Failed Stability Specifications
Class III · Low risk
Riomet (metformin hydrochloride oral solution)
Labeling: Not Elsewhere Classified: Sun Pharma has decided to initiate this recall in response to identified labeling discrepancies in the patient literature.
Class III · Low risk
Diltiazem HCl Extended-Release Capsules
Failed Dissolution Specifications. High dissolution results were obtained during stability testing.
Class III · Low risk
Diltiazem CD
Failed Dissolution Specifications. High dissolution results were obtained during stability testing.
Class III · Low risk
Diltiazem HCl Extended-Release Capsules
Failed Dissolution Specifications. High dissolution results were obtained during stability testing.