The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1012-2020·Announced 2020-03-25

Perrigo Recalls Ranitidine Tablets Due to Potential N-Nitrosodimethylamine Contamination

Perrigo Company PLC is recalling Regular Strength Acid Reducer (Ranitidine) 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 aligns with the rubric criteria for Severe severity.

Plain-English summary

Perrigo Company PLC is recalling Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 30 tablets per bottle. The recall is being conducted due to a Current Good Manufacturing Practice (CGMP) deviation and the possible contamination of the product with the impurity N-nitrosodimethylamine.

The affected product is distributed nationwide in the United States. The recall includes multiple brand names and NDC codes, including CVS Health, Equaline, Family Wellness, Good Sense, H.E.B., Harris Teeter, Health Mart, Leader, Major, Signature Care, Sunmark, Up & Up, and Walgreens. Specific lot numbers subject to the recall include 8DE1363, 8EE1558, 8FE1450, 8GE1331, 8HE1221, 8KE2825, 8JE1916, 8KE2243, 8ME2685, 9AE2785, 9AE2786, 9DE2721, 9CE3317, 9EE2579, 9FE2957, 9GE2785, 9GE3218, and 9HE3577.

Consumers should check their medication bottles for the NDC codes and lot numbers listed above. If the product matches the recalled items, consumers should stop using it and contact their pharmacist or healthcare provider for guidance on disposal or replacement.

The recalled product

Product
Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 30 tablets per bottle. [NDC: Brand] NDC CVS Health: 69842-293-65; NDC Equaline 41163-931-65; NDC Family Wellness: 55319-876-65; NDC Good Sense 0113-0876-65; NDC H.E.B.: 37808-876-65; NDC Harris Teeter: 69256-876-65…
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 (18)

  • Lots: 8DE1363
  • 8EE1558
  • 8FE1450
  • 8GE1331
  • 8HE1221
  • 8KE2825
  • 8JE1916
  • 8KE2243
  • 8ME2685
  • 9AE2785
  • 9AE2786
  • 9DE2721
  • 9CE3317
  • 9EE2579
  • 9FE2957
  • 9GE2785
  • 9GE3218
  • 9HE3577

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 →

Related recalls

Same manufacturer · Perrigo Company PLC

See all →

Same hazard · nitrosamine contamination

See all →

Similar recalls