The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1028-2020·Announced 2020-03-25

Perrigo Recalls Ranitidine Tablets Due to Potential N-Nitrosodimethylamine Contamination

Perrigo Company PLC is recalling Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 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 source text identifies the recall as FDA Class II and cites possible contamination with N-nitrosodimethylamine, a known carcinogen, which aligns with the rubric criteria for Severe severity involving significant health risks.

Plain-English summary

Perrigo Company PLC is recalling Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 200 tablets per bottle. The recall involves specific lots of the product distributed nationwide in the United States. The affected NDCs include Basic Care (0113-7852-82), CVS Health (59779-540-82), HEB (37808-507-82), Signature Care (21130-116-82), and Walgreens (0363-0852-82).

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 specific lot numbers affected are: 8AE1291, 8AE1785, 8BE1415, 8CE1525, 8DE1201, 8DE1741, 8EE1323, 8FE1806, 8GE1965, 8HE1517, 8JE2161, 8KE2565, 8LE2261, 8ME2548, 9AE2658, 9BE3018, 9CE3861, 9DE3244, 9FE2820, 9FE3373, 9GE3094, 9HE3449, and 9JE2665.

Consumers should check their bottles for the NDC and lot number listed above. If the product matches the recalled items, they should stop using it and contact their pharmacist or the recalling firm for instructions on return or disposal.

The recalled product

Product
Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 200 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7852-82; NDC CVS Health: 59779-540-82; NDC HEB: 37808-507-82; NDC Signature Care: 21130-116-82; NDC Walgreens: 0363-0852-82
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: 8AE1291
  • 8AE1785
  • 8BE1415
  • 8CE1525
  • 8DE1201
  • 8DE1741
  • 8EE1323
  • 8FE1806
  • 8GE1965
  • 8HE1517
  • 8JE2161
  • 8KE2565
  • 8LE2261
  • 8ME2548
  • 9AE2658
  • 9BE3018
  • 9CE3861
  • 9DE3244
  • 9FE2820
  • 9FE3373

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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