CLASS II Drug recall · Reported 25 Mar 2020 · FDA Enforcement Report
Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets recalled
Perrigo is recalling Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg per, distributed nationwide in the US. The recall was initiated on 23 Oct 2019 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1020-2020
- FDA event ID
- 84127
- Recalling firm
- Perrigo, Allegan, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Oct 2019
- FDA classified
- 13 Mar 2020
- Reported
- 25 Mar 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Nitrosamine Impurity
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 23 Oct 2019 | Recall initiated by company | |
| 13 Mar 2020 | Classified by FDA | +142 days |
| 25 Mar 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Nitrosamines are impurities that can form during drug manufacturing or storage. Above the FDA acceptable intake limit, long-term exposure may raise cancer risk. The FDA advises patients to keep taking the medicine until they have a replacement.
Product as listed by the FDA
Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 40 tablets per bottle. [Brand, NDC] NDC Up & Up: 11673-950-58
Where it was distributed
Nationwide USA
Questions about this recall
Why was it recalled?
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Which lots are affected?
Lots: 9BE3161, 9CE3880, 9EE2500, 9FE2823, 9GE2656, 9HE3554, 9JE2676
Where was it sold?
Nationwide USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
16 other products · FDA event 84127This product is part of a recall event; the main page for the event is Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg recalled.
More recalls from Perrigo
All 106| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Children's Pain & Fever Acetaminophen recalled by Perrigo Company | Perrigo | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Children's Cherry Flavored Acetaminophen Oral Suspension (160mg recalled | Perrigo | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Nasal Spray Decongestant, No Drip, Oxymetazoline HCl recalledNasal | Perrigo | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Acetaminophen Oral Suspension Grape Flavor, 160 mg recalled | Perrigo | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Maximum Strength Nasal Spray recalled by Perrigo CompanyNasal | Perrigo | Manufacturing (CGMP) Deviations | Nationwide |
Other Maximum Strength Acid Reducer recalls
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets recalled | Perrigo | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg [ recalled | Perrigo | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg recalled | Perrigo | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets recalled | Perrigo | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg recalled | Perrigo | Nitrosamine Impurity | Nationwide |