Perrigo Recalls Ranitidine Tablets Due to Possible N-Nitrosodimethylamine Contamination
Perrigo Company PLC 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 rating under the rubric, particularly given the potential for significant health consequences from N-nitrosodimethylamine contamination.
Plain-English summary
Perrigo Company PLC is recalling Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 65 tablets per bottle. 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 affected product is distributed nationwide in the United States. The recall includes specific lots identified by codes such as 8AE1752, 8BE1412, and 9GE2934. The product is sold under various brand names, including Care One, CVS Health, Family Wellness, Good Neighbor Pharmacy, HEB, Health Mart, Meijer, Rite Aid, Shopko, Sound Body, Sunmark, Up & Up, and Walgreens.
Consumers should check their medication bottles for the affected lot numbers and NDC codes. 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
- Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 65 tablets per bottle. [Brand, NDC] NDC Care One: 41520-392-09; NDC CVS Health: 59779-540-09; NDC Family Wellness: 55319-852-09; NDC Good Neighbor Pharmacy: 46122-532-09; NDC HEB: 37808-507-09; NDC Health Mart: 49348-
- Manufacturer
- Perrigo Company PLC
- 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: 8AE1752
- 8BE1412
- 8CE1437
- 8CE1439
- 8DE1141
- 8DE1737
- 8EE1318
- 8FE1690
- 8GE1928
- 8HE1395
- 8JE2155
- 8KE2516
- 8LE2253
- 8LE2624
- 9AE2522
- 9BE2933
- 9BE2934
- 9CE3734
- 9DE3070
- 9EE2830
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.
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