The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0612-2020·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).

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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 and involves NDMA, a known carcinogenic impurity, which aligns with the rubric criterion for 'Severe' severity involving significant health risks or agency classifications requiring high vigilance.

Plain-English summary

Amneal Pharmaceuticals, Inc. is recalling Ranitidine Tablets, USP 150 mg, in 60-, 100-, 180-, 500-, and 1000-count bottles. The recall is due to Current Good Manufacturing Practice (CGMP) deviations, specifically the presence of the impurity N-nitrosodimethylamine (NDMA) in the active pharmaceutical ingredient (API).

The affected product was distributed throughout the United States. The recall covers multiple lot numbers manufactured between November 2019 and March 2021.

Consumers should stop using the recalled product and contact their healthcare provider for guidance on alternative treatments. The FDA has classified this recall as Class II, indicating a reasonable probability that adverse health consequences may be temporary or medically reversible.

The recalled product

Product
Ranitidine Tablets, USP 150 mg a).60-count bottles (NDC 65162-253-06) , b).100-count bottles (NDC 65162-253-10), c).180-count bottles (NDC 65162-253-18), d).500-count bottles (NDC 65162-253-50) and e)1000-count bottles (NDC 65162-253-11).
Manufacturer
Amneal Pharmaceuticals, Inc.
Category
Drug — Tablets
Hazard

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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