The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1013-2020·Announced 2020-03-25

Perrigo Recalls Ranitidine Tablets Due to Potential N-Nitrosodimethylamine Contamination

Perrigo Company PLC is recalling specific lots of Regular Strength Acid Reducer (Ranitidine 75 mg) tablets due to a CGMP deviation and possible contamination with the impurity N-nitrosodimethylamine.

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 potential contamination with N-nitrosodimethylamine, a known carcinogen, which meets the rubric criteria for a Severe rating (FDA Class II with significant health risk).

Plain-English summary

Perrigo Company PLC is recalling specific lots of Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 60 tablets per bottle. The recall is being conducted due to a Current Good Manufacturing Practice (CGMP) deviation and the possibility of contamination with the impurity N-nitrosodimethylamine.

The affected product is distributed nationwide in the United States. The recall includes specific lot numbers: 8DE1367, 8EE1559, 8FE1451, 8GE1340, 8HE1222, 8KE2831, 8JE1917, 8KE2245, 8ME2724, 9AE2831, 9DE2747, 9CE3339, 9EE2636, 9FE2971, and 9GE2793. The product is available under several NDC codes, including those for Health Mart, Major, Meijer, and Sunmark brands.

Consumers who have purchased these specific lots of Ranitidine tablets should stop using the product and contact their healthcare provider or pharmacist for guidance. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 60 tablets per bottle. [NDC: Brand] NDC Health Mart: 62011-0283-2; NDC Major: 0904-6715-52; NDC Meijer: 41250-252-72; NDC Sunmark: 49348-136-12;
Manufacturer
Perrigo Company PLC
Category
Drug — Prescription/OTC Medication
Hazard

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 (16)

  • Lots: 8DE1367
  • 8EE1559
  • 8FE1451
  • 8GE1340
  • 8HE1222
  • 8KE2831
  • 8JE1917
  • 8KE2245
  • 8ME2724
  • 9AE2831
  • 9DE2747
  • 9CE3339
  • 9EE2636
  • 9FE2971
  • 9GE2793
  • 9GE3220

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 17 recalled by Perrigo Company PLC 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 17 products in this recall →

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