The Recall Desk
SevereFDA (Drugs)·D-1015-2020·Announced 2020-03-25

Perrigo Recalls Ranitidine Tablets Due to Possible N-Nitrosodimethylamine Contamination

Perrigo Company PLC is recalling specific lots of Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 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. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or specific high-risk contexts are rated Severe (4). While no specific injuries are reported in the text, the presence of a known carcinogenic impurity (NDMA) in a Class II drug recall typically warrants a Severe rating under the 'significant injury' or high-risk interpretation of the rubric, as Class II is the second-highest FDA classification.

Plain-English summary

Perrigo Company PLC is recalling Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 150 tablets per bottle. The affected products are identified by NDC codes 37808-876-47 (H.E.B.) and 49035-876-47 (Equate). The recall covers specific lot numbers including 8CE1644, 8CE1645, 8DE1401, and others listed in the official notice.

The recall was initiated due to a Current Good Manufacturing Practice (CGMP) deviation and the possibility of contamination with the impurity N-nitrosodimethylamine. The products were distributed nationwide in the United States.

Consumers with these specific products should stop using them and contact their healthcare provider or the recalling firm for further instructions. 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, 150 tablets per bottle. [NDC: Brand] NDC H.E.B.: 37808-876-47; NDC Equate: 49035-876-47
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: 8CE1644
  • 8CE1645
  • 8DE1401
  • 8DE1402
  • 8DE1403
  • 8DE1769
  • 8DE1773
  • 8EE1561
  • 8EE1562
  • 8FE1453
  • 8FE1454
  • 8GE1342
  • 8HE1224
  • 8KE2248
  • 8KE2833
  • 8JE1918
  • 8KE2247
  • 8ME2727
  • 8ME2729
  • 9DE2750

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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