The Recall Desk
SevereFDA (Drugs)·D-1021-2020·Announced 2020-03-25

Perrigo Recalls Ranitidine Tablets Due to Potential N-Nitrosodimethylamine Contamination

Perrigo is recalling Maximum Strength Acid Reducer Ranitidine tablets due to a CGMP deviation and possible contamination with the impurity N-nitrosodimethylamine.

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 severity score under the rubric, particularly given the potential for significant injury from N-nitrosodimethylamine contamination.

Plain-English summary

Perrigo Company PLC is recalling Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 50 tablets per bottle. The recall involves multiple NDC codes, including those for DG Health, Good Neighbor Pharmacy, Good Sense, Harris Teeter, Kroger, Major, Meijer, Publix, Rite Aid, Signature Care, and Topcare.

The recall was initiated due to a Current Good Manufacturing Practice (CGMP) deviation and the possibility of contamination with the impurity N-nitrosodimethylamine. The affected lots include 8AE1744, 8BE1369, 8CE1377, 8CE1378, 8DE1103, 8DE1531, 8EE1700, 8FV0829, 8DE1722, 8EE1317, 8FE1635, 8GE1921, 8HE1342, 8KE2503R, 8JE2154, 8KE2503, 8LE2198, 8LE2597, 9AE2499, 9BE2862, 9BE2863, 9CE3723, 9DE2890, 9DE2891, 9EE2812, 9FE3187, 9GE2885, 9HE3435, and 9JE2656.

The product was distributed nationwide in the United States. Consumers should check their medication bottles for the specific lot numbers listed above. If the lot number matches, consumers should stop using the product and contact their healthcare provider or pharmacist for guidance.

The recalled product

Product
Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 50 tablets per bottle. [Brand, NDC] NDC DG Health: 55910-852-71; NDC Good Neighbor Pharmacy: 46122-224-71; NDC Good Sense: 0113-0852-71; NDC Harris Teeter: 69256-041-71; NDC Kroger: 30142-600-71; NDC Major: 0904-6716-
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 (20)

  • Lots: 8AE1744
  • 8BE1369
  • 8CE1377
  • 8CE1378
  • 8DE1103
  • 8DE1531
  • 8EE1700
  • 8FV0829
  • 8DE1722
  • 8EE1317
  • 8FE1635
  • 8GE1921
  • 8HE1342
  • 8KE2503R
  • 8JE2154
  • 8KE2503
  • 8LE2198
  • 8LE2597
  • 9AE2499
  • 9BE2862

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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