FDA Drug Recalls

2,277 recalls · Class II, newest first

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

RANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA NDC 62207-773-32

Reason CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Granules India Limited NDC 62207-773-32 D-0632-2020

Class II · Moderate risk Ongoing Nov 22, 2019

Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02.

Reason CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Amneal Pharmaceuticals, Inc. NDC 53746-254-02 D-0616-2020

Class II · Moderate risk Ongoing Nov 22, 2019

Ranitidine Tablets, USP 150 mg, 1000-count bottles, NDC 53746-253-10.

Reason CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Amneal Pharmaceuticals, Inc. NDC 53746-253-10 D-0615-2020

Class II · Moderate risk Ongoing Nov 22, 2019

Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90.

Reason CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Amneal Pharmaceuticals, Inc. NDC 65162-664-90 D-0614-2020

Class II · Moderate risk Ongoing Nov 22, 2019

Ranitidine Tablets, USP 300 mg - a).30-count bottles (NDC 65162-254-30), b).100-count bottles (NDC 65162-254-10) and c)…

Reason CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Amneal Pharmaceuticals, Inc. NDC 65162-254-30 D-0613-2020

Class II · Moderate risk Ongoing Nov 22, 2019

Ranitidine Tablets, USP 150 mg a).60-count bottles (NDC 65162-253-06) , b).100-count bottles (NDC 65162-253-10), c).180-count…

Reason CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Amneal Pharmaceuticals, Inc. NDC 65162-253-06 D-0612-2020

Class II · Moderate risk Ongoing Nov 6, 2019

Aurobindo Ranitidine Capsules 150 mg, 500 count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279…

Reason CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.

AuroMedics Pharma LLC NDC 59651-144-05 D-0530-2020

Class II · Moderate risk Ongoing Nov 6, 2019

Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5mL) 474 mL bottle, Rx only Distributed by: Aurobindo Pharma…

Reason CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.

AuroMedics Pharma LLC NDC 65862-431-74 D-0529-2020

Class II · Moderate risk Ongoing Nov 6, 2019

Aurobindo Ranitidine Capsules 300 mg, 30-count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279…

Reason CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.

AuroMedics Pharma LLC NDC 59651-145-30 D-0528-2020

Class II · Moderate risk Ongoing Nov 6, 2019

Aurobindo Ranitidine Caspules 150 mg, 60-count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279…

Reason CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.

AuroMedics Pharma LLC NDC 59651-144-60 D-0527-2020

Class II · Moderate risk Ongoing Nov 6, 2019

DG Health Acid Reducer Ranitidine Tablets 150 mg, 8-count carton, Distributed by: Dolgencorp LLC 100 Mission Ridge Goodletville…

Reason CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.

AuroMedics Pharma LLC NDC 55910-092-79 D-0526-2020

Class II · Moderate risk Ongoing Oct 22, 2019

Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 0597-0122-01 …

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

Sanofi-Aventis U.S. LLC D-0545-2020

Class II · Moderate risk Ongoing Oct 22, 2019

Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 66715-9736-2…

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

Sanofi-Aventis U.S. LLC D-0544-2020

Class II · Moderate risk Ongoing Oct 22, 2019

Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC…

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

Sanofi-Aventis U.S. LLC NDC 68151-2584-0 D-0543-2020

Class II · Moderate risk Ongoing Oct 22, 2019

Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219…

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

Sanofi-Aventis U.S. LLC D-0542-2020

Class II · Moderate risk Ongoing Oct 22, 2019

Regular Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC…

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

Sanofi-Aventis U.S. LLC NDC 67751-151-01 D-0541-2020

Class II · Moderate risk Ongoing Oct 22, 2019

Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC…

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

Sanofi-Aventis U.S. LLC NDC 50269-222-25 D-0540-2020

Class II · Moderate risk Ongoing Oct 22, 2019

Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219…

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

Sanofi-Aventis U.S. LLC D-0539-2020

Class II · Moderate risk Ongoing Oct 22, 2019

Cool Mint Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN…

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

Sanofi-Aventis U.S. LLC D-0538-2020