FDA Drug Recalls

2,661 recalls, newest first

Class II · Moderate risk Ongoing May 29, 2020

amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx Only, 500 Tablets bottles, Manufactured by: Amneal…

Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Amneal Pharmaceuticals of New York, LLC NDC 65162-178-50 D-1345-2020

Class II · Moderate risk Ongoing May 29, 2020

amneal Metformin Hydrochloride Extended-release Tablets, USP 500 mg Rx Only 90 Tablets bottles, Manufactured by: Amneal…

Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Amneal Pharmaceuticals of New York, LLC NDC 65162-178-09 D-1344-2020

Class II · Moderate risk Ongoing May 29, 2020

amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, Rx Only, 100 count bottles, Distributed by: Amneal…

Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Amneal Pharmaceuticals of New York, LLC NDC 53746-0178-01 D-1343-2020

Class II · Moderate risk Ongoing May 19, 2020

Maximum Strength Lidocaine Cold & Hot Patch (lidocaine 4%, menthol 1%), 5 patches per box, Distributed by: CVS Pharmacy, Inc…

Reason CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain…

Wuhan Bingbing Pharmaceutical Co., Ltd. NDC 66902-218-05 D-1280-2020

Class II · Moderate risk Ongoing May 19, 2020

Mencaine (lidocaine 4.5%, menthol 5%) Patch, 1 patch per pouch, Manufactured For: Terrain Pharmaceuticals, Reno, NV 89501; NDC…

Reason CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain…

Wuhan Bingbing Pharmaceutical Co., Ltd. NDC 53225-1090-1 D-1279-2020

Class II · Moderate risk Ongoing May 19, 2020

LidoPro (lidocaine 4%, menthol 5%, methyl salicylate 4%) patch, 15 Patches per box, Manufactured For: Terrain Pharmaceuticals…

Reason CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain…

Wuhan Bingbing Pharmaceutical Co., Ltd. NDC 53225-1023-1 D-1278-2020

Class II · Moderate risk Ongoing May 19, 2020

LidoPatch (lidocaine HCl 3.6%, menthol 1.25%) Pain Relief Patch, packaged in 1 patch/box (NDC 10882-527-01); 30 patches/box (NDC…

Reason CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain…

Wuhan Bingbing Pharmaceutical Co., Ltd. NDC 10882-527-01 D-1277-2020

Class II · Moderate risk Ongoing Mar 25, 2020

LOSARTAN POTASSIUM TABLETS, USP 100 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by…

Reason CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to…

Teva Pharmaceuticals USA NDC 0591-3747-00 D-1102-2020

Class II · Moderate risk Ongoing Mar 25, 2020

LOSARTAN POTASSIUM TABLETS, USP 50 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by…

Reason CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to…

Teva Pharmaceuticals USA NDC 0591-3746-00 D-1101-2020

Class II · Moderate risk Ongoing Mar 25, 2020

LOSARTAN POTASSIUM TABLETS, USP 25 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by…

Reason CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to…

Teva Pharmaceuticals USA NDC 0591-3745-00 D-1100-2020

Class II · Moderate risk Ongoing Dec 17, 2019

Glenmark Ranitidine Tablets USP 150 mg Rx Only 500 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa…

Reason CGMP Deviations: Presence of NDMA impurity detected in product.

Glenmark Pharmaceuticals Inc., USA NDC 68462-248-05 D-0644-2020

Class II · Moderate risk Ongoing Dec 17, 2019

Glenmark Ranitidine Tablets USP 300 mg Rx Only 250 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa…

Reason CGMP Deviations: Presence of NDMA impurity detected in product.

Glenmark Pharmaceuticals Inc., USA NDC 68462-249-20 D-0643-2020

Class II · Moderate risk Ongoing Dec 17, 2019

Glenmark Ranitidine Tablets USP 300 mg Rx Only 100 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa…

Reason CGMP Deviations: Presence of NDMA impurity detected in product.

Glenmark Pharmaceuticals Inc., USA NDC 68462-249-01 D-0642-2020

Class II · Moderate risk Ongoing Dec 17, 2019

Glenmark Ranitidine Tablets USP 300 mg Rx Only 30 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa…

Reason CGMP Deviations: Presence of NDMA impurity detected in product.

Glenmark Pharmaceuticals Inc., USA NDC 68462-249-30 D-0641-2020

Class II · Moderate risk Ongoing Dec 17, 2019

Glenmark Ranitidine Tablets USP 150 mg Rx Only 100 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa…

Reason CGMP Deviations: Presence of NDMA impurity detected in product.

Glenmark Pharmaceuticals Inc., USA NDC 68462-248-01 D-0640-2020

Class II · Moderate risk Ongoing Dec 17, 2019

Glenmark Ranitidine Tablets USP 150 mg Rx Only 60 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa…

Reason CGMP Deviations: Presence of NDMA impurity detected in product.

Glenmark Pharmaceuticals Inc., USA NDC 68462-248-60 D-0639-2020

Class II · Moderate risk Ongoing Dec 13, 2019