Perrigo Recalls Ranitidine Tablets Due to Potential N-Nitrosodimethylamine Contamination
Perrigo Company PLC is recalling Regular Strength Acid Reducer 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, which corresponds to a Severe severity score under the rubric, particularly given the potential contamination with a known carcinogenic impurity.
Plain-English summary
Perrigo Company PLC is recalling Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 80 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 the codes: 8CE1643, 8DE1370, 8DE1768, 8EE1560, 8FE1452, 8GE1341, 8HE1223, 8KE2832, 8KE2246, 8ME2725, 9AE2835, 9CE3378, 9DE2748, 9EE2637, 9FE2976, 9GE2795, 9GE3228, and 9HE3617. The product is available under various brand names, including Basic Care, CVS Health, Leader, Up & Up, and Walgreens.
Consumers should check their medication bottles for the affected lot numbers and NDC codes. If the product matches the recalled description, consumers should stop using it and contact their healthcare provider or pharmacist for guidance on alternatives or disposal.
The recalled product
- Product
- Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 80 tablets per bottle. [NDC: Brand] NDC Basic Care: 0113-7876-27; NDC CVS Health: 69842-293-27; NDC Leader: 70000-0375-2; NDC Up & Up: 11673-876-27; NDC Walgreens: 0363-1876-27
- Manufacturer
- Perrigo Company PLC
- Category
- Drug — Tablets
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 (18)
- Lots: 8CE1643
- 8DE1370
- 8DE1768
- 8EE1560
- 8FE1452
- 8GE1341
- 8HE1223
- 8KE2832
- 8KE2246
- 8ME2725
- 9AE2835
- 9CE3378
- 9DE2748
- 9EE2637
- 9FE2976
- 9GE2795
- 9GE3228
- 9HE3617
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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