FDA Drug Shortages

Current and Resolved Drug Shortages and Discontinuations Reported to FDA

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Ranitidine Tablets/Capsules
Status: Currently in Shortage
»Date first posted: 01/07/2020
»Therapeutic Categories: Gastroenterology; Pediatric

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Ajanta Pharma USA Inc (New 01/07/2020)

Company Contact Information:
855-664-7744

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
150 mg 60’s count bottle (NDC 27241-109-06) Available
150 mg 500’s count bottle (NDC 27241-109-50) Available
300 mg 30’s count bottle (NDC 27241-110-03) Available
300 mg 100’s count bottle (NDC 27241-110-10) Available

Amneal Pharmaceutical (New 01/07/2020)

Company Contact Information:
866-525-7270

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
150 mg, 60 count (NDC 65162-253-06) Unknown at this time Ranitidine Tablets, USP, 150 mg and 300 mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL, are being recalled because of potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA. Requirements related to complying with good manufacturing practices
150 mg, 100 count (NDC 65162-253-10) Unknown at this time Ranitidine Tablets, USP, 150 mg and 300 mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL, are being recalled because of potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA. Requirements related to complying with good manufacturing practices
150 mg, 180 count (NDC 65162-253-18) Unknown at this time Ranitidine Tablets, USP, 150 mg and 300 mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL, are being recalled because of potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA. Requirements related to complying with good manufacturing practices
150 mg, 500 count (NDC 65162-253-50) Unknown at this time Ranitidine Tablets, USP, 150 mg and 300 mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL, are being recalled because of potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA. Requirements related to complying with good manufacturing practices
150 mg, 1000 count (NDC 65162-253-11) Unknown at this time Ranitidine Tablets, USP, 150 mg and 300 mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL, are being recalled because of potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA. Requirements related to complying with good manufacturing practices
150 mg, 1000 count (NDC 65162-253-11) Unknown at this time Ranitidine Tablets, USP, 150 mg and 300 mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL, are being recalled because of potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA. Requirements related to complying with good manufacturing practices
300 mg, 30 count (NDC 65162-254-03) Unknown at this time Ranitidine Tablets, USP, 150 mg and 300 mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL, are being recalled because of potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA. Requirements related to complying with good manufacturing practices
300 mg, 100 count (NDC 65162-254-10) Unknown at this time Ranitidine Tablets, USP, 150 mg and 300 mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL, are being recalled because of potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA. Requirements related to complying with good manufacturing practices
300 mg, 250 count (NDC 65162-254-25) Unknown at this time Ranitidine Tablets, USP, 150 mg and 300 mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL, are being recalled because of potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA. Requirements related to complying with good manufacturing practices
300 mg, 250 count (NDC 53746-254-02) Unknown at this time Ranitidine Tablets, USP, 150 mg and 300 mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL, are being recalled because of potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA. Requirements related to complying with good manufacturing practices

Appco Pharma LLC (New 01/07/2020)

Company Contact Information:
732-253-7735

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
150mg 60 count bottle (NDC 62559-690-60) Unavailable ANI Pharmaceuticals is the distributor -customer service (218) 634-3655 Regulatory delay
150mg 500 count bottle (NDC 62559-690-05) Unavailable ANI Pharmaceuticals is the distributor-customer service (218) 634-3655 Regulatory delay
300mg 30 count bottle (NDC 62559-691-30) Unavailable ANI Pharmaceuticals is the distributor-customer service (218) 634-3655 Regulatory delay

Dr. Reddy's Laboratories, Inc. (New 01/07/2020)

Company Contact Information:
866-733-3952

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
150mg 60 count bottle (NDC 5511112960) TBD Ranitidine Capsules (prescription) and tablets (OTC) are the subject of nationwide voluntary recall for all lots which was announced on October 23rd. FDA updates on Ranitidine recalls. Other
150mg 500 count bottle (NDC 5511112905) TBD Ranitidine Capsules (prescription) and tablets (OTC) are the subject of nationwide voluntary recall for all lots which was announced on October 23rd. FDA updates on Ranitidine recalls. Other
300mg 30 count bottle (NDC 5511113030) TBD Ranitidine Capsules (prescription) and tablets (OTC) are the subject of nationwide voluntary recall for all lots which was announced on October 23rd. FDA updates on Ranitidine recalls. Other
300mg 100 count bottle (NDC 5511113001) TBD Ranitidine Capsules (prescription) and tablets (OTC) are the subject of nationwide voluntary recall for all lots which was announced on October 23rd. FDA updates on Ranitidine recalls. Other

Glenmark Pharmaceuticals (New 01/07/2020)

Company Contact Information:
888-721-7115

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
150mg 60 count bottle (NDC 68462-248-60) Undetermined Glenmark is still in process of gathering information on test results and will make a decision regarding recommencing commercial distribution upon completion of thorough evaluation of test results and associated risk assessments Requirements related to complying with good manufacturing practices
150mg 100 count bottle (NDC 68462-248-01) Undetermined Glenmark is still in process of gathering information on test results and will make a decision regarding recommencing commercial distribution upon completion of thorough evaluation of test results and associated risk assessments Requirements related to complying with good manufacturing practices
150mg 500 count bottle (NDC 68462-248-05) Undetermined Glenmark is still in process of gathering information on test results and will make a decision regarding recommencing commercial distribution upon completion of thorough evaluation of test results and associated risk assessments Requirements related to complying with good manufacturing practices
300mg 30 count bottle (NDC 68462-249-30) Undetermined Glenmark is still in process of gathering information on test results and will make a decision regarding recommencing commercial distribution upon completion of thorough evaluation of test results and associated risk assessments Requirements related to complying with good manufacturing practices
300mg 100 count bottle (NDC 68462-249-01) Undetermined Glenmark is still in process of gathering information on test results and will make a decision regarding recommencing commercial distribution upon completion of thorough evaluation of test results and associated risk assessments Requirements related to complying with good manufacturing practices
300mg 250 count bottle (NDC 68462-249-20) Undetermined Glenmark is still in process of gathering information on test results and will make a decision regarding recommencing commercial distribution upon completion of thorough evaluation of test results and associated risk assessments Requirements related to complying with good manufacturing practices

Novitium Pharma LLC (New 01/07/2020)

Company Contact Information:
609-469-5920

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
150 mg, Bottle of 60 capsules (NDC 70954-001-20) Product is currently unavailable. Estimated shortage duration is until Q1 2020 Shortage of an active ingredient
150 mg, Bottle of 500 capsules (NDC 70954-001-40) Product is currently unavailable. Estimated shortage duration is until Q1 2020. Shortage of an active ingredient
300 mg, Bottle of 30 capsules (NDC 70954-002-10) Product is currently unavailable. Estimated shortage duration is until Q1 2020. Shortage of an active ingredient
300 mg, Bottle of 100 capsule (NDC 70954-002-40) Product is currently unavailable. Estimated shortage duration is until Q1 2020. Shortage of an active ingredient

Strides Pharma Inc. (New 01/07/2020)

Company Contact Information:
855-273-0146

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
150 mg, 60 count bottle (NDC 64380-0803-03) Available
150 mg, 100 count bottle (NDC 64380-0803-06) Available
150 mg, 500 count bottle (NDC 64380-0803-07) Available
150 mg, 1000 count bottle (NDC 64380-0803-08) Available
300 mg, 30 count bottle (NDC 64380-0804-04) Available
300 mg, 100 count bottle (NDC 64380-0804-06) Available
300 mg, 250 count bottle (NDC 64380-0804-38) Available

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