Ranitidine Tablet
FDA Recall NDC 53746-253

FDA Enforcement Report: View Recall Date, Reasons, and Safety Status

Active & Historical Enforcement Reports

The FDA has identified 2 recorded enforcement report(s) associated with Ranitidine (NDC 53746-253). A significant event, classified as Class II, was initiated on Nov 22, 2019 by Amneal Pharmaceuticals Of New York Llc. The reported reason for this action was: "CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API"

This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.

Reported Recall Events

D-0616-2020ONGOINGD-0615-2020ONGOING

November 2019 Class II Recall: CGMP Deviations

Recall Number
D-0616-2020
Class II Ongoing
Reason for Recall
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Initiated
Nov 22, 2019
Reported
Dec 18, 2019
Quantity
N/A

Recall Profile & Regulatory Data

Event ID
84353
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Amneal Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed throughout the United States.
Product Description
Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02.
Batch or Lot Expiration Information
Lot# HB04118A 2/2020 HB04218A 2/2020 HB04318A 2/2020 HB04418A 2/2020 HF13518A 6/2020 HF13618A 6/2020 HF13718A 6/2020 HF13818A 6/2020 HK02818A 9/2020 HK02918A 9/2020 HK03018A 9/2020 HK03118A 9/2020 HL08418A 11/2020 HL08518A 11/2020 HL08618A 11/2020 HL08718A 11/2020 HB01419A 1/2021 HB05619A 1/2021 HB05719A 1/2021 HB05819A 1/2021 HB05919A 1/2021 HB06019A 1/2021 HB06119A 1/2021
Affected Packages Involved in this Recall
53746-253-60Product
53746-253-01Product
53746-253-18Product
53746-253-05Product
53746-253-10Product
53746-254-30Product
53746-254-01Product
53746-254-02Product

November 2019 Class II Recall: CGMP Deviations

Recall Number
D-0615-2020
Class II Ongoing
Reason for Recall
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Initiated
Nov 22, 2019
Reported
Dec 18, 2019
Quantity
N/A

Recall Profile & Regulatory Data

Event ID
84353
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Amneal Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed throughout the United States.
Product Description
Ranitidine Tablets, USP 150 mg, 1000-count bottles, NDC 53746-253-10.
Batch or Lot Expiration Information
Lot# HB03718A 3/2020 HB03818A 3/2020 HB03918A 3/2020 HB04018A 3/2020 HC01618A 3/2020 HC14618A 5/2020 HC14718A 5/2020 HC14818A 5/2020 HC14918A 5/2020 HC15018A 5/2020 HK02318A 9/2020 HK02418A 9/2020 HK02518A 9/2020 HK02618A 9/2020 HD03119A 3/2021 HD03219A 3/2021 HE03119A 4/2021 HE03219A 4/2021
Affected Packages Involved in this Recall
53746-253-60Product
53746-253-01Product
53746-253-18Product
53746-253-05Product
53746-253-10Product
53746-254-30Product
53746-254-01Product
53746-254-02Product

About FDA Recall Enforcement Reports

FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.

If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.