Class II · Moderate risk
amneal Metformin Hydrochloride Extended-release Tablets
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Ongoing drug recalls - open right now
Every FDA drug recall whose status is still Ongoing: the firm is still removing product from the market, or the FDA has not yet closed the file. Some were opened years ago and never formally terminated, so check the initiation date as well as the status.
2,760 recalls, newest first.
Class II · Moderate risk
amneal Metformin Hydrochloride Extended-Release Tablets
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk
Maximum Strength Lidocaine Cold & Hot Patch
CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
Class II · Moderate risk
Mencaine (lidocaine 4.5%, menthol 5%)
CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
Class II · Moderate risk
LidoPro (lidocaine 4%, menthol 5%, methyl salicylate 4%)
CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
Class II · Moderate risk
LidoPatch (lidocaine HCl 3.6%, menthol 1.25%)
CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
Class II · Moderate risk
Losartan Potassium Tablets
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Class II · Moderate risk
Losartan Potassium Tablets
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Class II · Moderate risk
Losartan Potassium Tablets
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Class II · Moderate risk
Glenmark Ranitidine Tablets USP 150 mg Rx Only 500 Tablets…
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Glenmark Ranitidine Tablets USP 300 mg Rx Only 250 Tablets…
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Glenmark Ranitidine Tablets USP 300 mg Rx Only 100 Tablets…
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Glenmark Ranitidine Tablets USP 300 mg Rx Only 30 Tablets…
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Glenmark Ranitidine Tablets USP 150 mg Rx Only 100 Tablets…
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Glenmark Ranitidine Tablets USP 150 mg Rx Only 60 Tablets…
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Ranitidine Tablets
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk
Ranitidine Tablets
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk
Ranitidine Tablets
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk
Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz.
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk
Ranitidine Tablets
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk
Ranitidine Tablets
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk
Aurobindo Ranitidine Capsules 150 mg
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Class II · Moderate risk
Ranitidine Syrup
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Class II · Moderate risk
Aurobindo Ranitidine Capsules 300 mg
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Class II · Moderate risk
Aurobindo Ranitidine Caspules 150 mg
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.