The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1019-2020·Announced 2020-03-25

Perrigo Recalls Ranitidine Tablets Due to Possible N-Nitrosodimethylamine Contamination

Perrigo Company PLC is recalling Maximum Strength Acid Reducer, Cool Mint 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. According to the rubric, FDA Class II recalls involving significant injury/property-damage reports or high-risk contaminants like N-nitrosodimethylamine (a probable human carcinogen) are categorized as Severe (Score 4).

Plain-English summary

Perrigo Company PLC is recalling Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 24 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 National Drug Codes (NDCs), including Care One, CVS Health, DG Health, Equaline, Family Wellness, Good Neighbor Pharmacy, HEB, Kroger, Leader, Meijer, Rite Aid, Shopko, Signature Care, Topcare, and Walgreens. Specific lot numbers are listed in the official recall notice.

Consumers should check their medication bottles for the affected NDCs and lot numbers. If the product matches the recall details, consumers should stop using it and contact their pharmacist or healthcare provider for guidance on disposal or replacement.

The recalled product

Product
Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 24 tablets per bottle. [Brand, NDC] NDC Care One: 41520-609-62; NDC CVS Health: 59779-950-62; NDC DG Health: 55910-423-62; NDC Equaline: 41163-950-62; NDC Family Wellness: 55319-523-62; NDC Good Neighbor…
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: 8FV1462
  • 8GV1289
  • 8BE1465
  • 8CE1616
  • 8DE1277
  • 8DE1580
  • 8DE1766
  • 8FE1348
  • 8GE1527
  • 8GE1733
  • 8GE1735
  • 8HE1466
  • 8HE1590
  • 8JE2232
  • 8KE2676
  • 8LE2283
  • 8LE2284
  • 8LE2345
  • 8ME2640
  • 9AE2663

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