The Recall Desk
SevereFDA (Drugs)·D-0615-2020·Announced 2019-12-18

Amneal Recalls Ranitidine Tablets Due to NDMA Impurity

Amneal Pharmaceuticals is recalling Ranitidine Tablets 150 mg because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the presence of a potential carcinogenic impurity (NDMA) in a prescription drug.

Plain-English summary

Amneal Pharmaceuticals, Inc. is recalling Ranitidine Tablets, USP 150 mg, 1000-count bottles (NDC 53746-253-10). The recall is due to Current Good Manufacturing Practice (CGMP) deviations, specifically the detection of the impurity N-nitrosodimethylamine (NDMA) in the active pharmaceutical ingredient (API).

The affected product was distributed throughout the United States. The recall includes specific lot numbers with expiration dates ranging from March 2020 to April 2021, including lots HB03718A, HB03818A, HB03918A, HB04018A, HC01618A, HC14618A, HC14718A, HC14818A, HC14918A, HC15018A, HK02318A, HK02418A, HK02518A, HK02618A, HD03119A, HD03219A, HE03119A, and HE03219A.

Consumers should check their medication for the NDC 53746-253-10 and the listed lot numbers. If the product matches the recalled description, consumers should stop using it and contact their pharmacist or healthcare provider for guidance on alternatives or refunds.

The recalled product

Product
RANITIDINE (RANITIDINE)
Brand
RANITIDINE
Manufacturer
Amneal Pharmaceuticals, Inc.
Category
Drug — Prescription Drug
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

UPCs (2)

  • 0353746253019
  • 0353746254016

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 5 recalled by Amneal Pharmaceuticals, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

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