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.
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 risks associated with N-nitrosodimethylamine contamination.
Plain-English summary
Perrigo Company PLC is recalling Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 65 tablets per bottle. The recall involves multiple store brands, including Basic Care, CVS Health, Equate, Good Neighbor Pharmacy, Kroger, Topcare, Up & Up, and Walgreens.
The recall was initiated due to a Current Good Manufacturing Practice (CGMP) deviation and the possibility of contamination with the impurity N-nitrosodimethylamine. The affected products were distributed nationwide in the United States.
Consumers who have purchased these specific lot numbers should stop using the product and return it to the place of purchase for a refund or contact the manufacturer for further instructions.
The recalled product
- Product
- Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 65 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7950-09; NDC CVS Health: 59779-950-09; NDC Equate: 49035-800-09; NDC Good Neighbor Pharmacy: 46122-533-09; NDC Kroger: 30142-891-09; NDC Topcare: 3680
- Manufacturer
- Perrigo Company PLC
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: 8AE1884
- 8BE1466
- 8DE1318
- 8CE1617
- 8DE1319
- 8EE1326
- 8DE1611
- 8DE1767
- 8FE1350
- 8FE1352
- 8GE1736
- 8GE1840
- 8GE1859
- 8HE1592
- 8HE1593
- 8HE1594
- 8JE2234
- 9CE3263
- 8JE2233
- 8LE2360
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 →- ModerateCareOne Severe Congestion Nasal Spray Recalled Due to Contaminated Excipient
FDA (Drugs) · 2022-03-02
- ModerateEquate Children's Pain and Fever Acetaminophen Suspension Recall
FDA (Drugs) · 2022-03-02
- ModerateEqualine Nasal Oxymetazoline HCl Nasal Spray Recalled for Contaminated Excipient
FDA (Drugs) · 2022-03-02
- ModerateUP AND UP Childrens Acetaminophen Recall Due to Contaminated Excipient
FDA (Drugs) · 2022-03-02
- ModerateCVS Infant's Grape Acetaminophen Suspension Recalled for Contaminated Excipient
FDA (Drugs) · 2022-03-02
Same hazard · contamination
See all →- HighMedline Recalls 263 Surgical Convenience Kits Due to Contamination
FDA (Devices) · 2026-09-02
- HighMedline Recalls Surgical Convenience Kits Due to Contaminated Components
FDA (Devices) · 2026-09-02
- HighMedline Recalls 71 Convenience Kits Due to Contaminated Component
FDA (Devices) · 2026-09-02
- HighMedline Recalls Gynecologic Robotic Surgery Kits Due to Contamination
FDA (Devices) · 2026-09-02
- HighMedline C-Section Convenience Kits Recalled for Contaminated Components
FDA (Devices) · 2026-09-02