The Recall Desk
SevereFDA (Drugs)·D-0632-2020·Announced 2020-01-08

Ranitidine Tablets Recalled Due to NDMA Impurity

Granules India Limited is recalling Ranitidine tablets 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 known carcinogenic impurity (NDMA) in the active ingredient.

Plain-English summary

Granules India Limited is recalling Ranitidine tablets, USP 150mg, 10,000-count bags. The recall is due to Current Good Manufacturing Practice (CGMP) deviations where the impurity N-nitrosodimethylamine (NDMA) was found in the active pharmaceutical ingredient (API).

The affected product is identified by NDC 62207-773-32 and includes specific lot codes ranging from 7730001A to 7730012A. The total quantity involved is 23,090,000 tablets. The product was distributed in Oregon, New York, and New Jersey.

Consumers should check their medication for the specific NDC and lot codes listed in the recall notice. If the product matches the description, they should stop using it and contact their healthcare provider or pharmacist for guidance.

The recalled product

Product
RANITIDINE (RANITIDINE)
Brand
RANITIDINE
Manufacturer
Granules India Limited
Category
Drug — Oral Solid Dosage
Hazard
Affected units
23,090,000

Is your product affected?

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

Lot numbers (11)

  • 7730001A
  • 7730002A
  • 7730003A
  • 7730004A
  • 7730005A
  • 7730006A
  • 7730007A
  • 7730008A
  • 7730009A
  • 7730010A
  • 7730011A and 7730012A

Distribution

Distributed in 3 states:

Related recalls

Same brand · RANITIDINE

Same hazard · ndma impurity

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