CLASS II Drug recall · Reported 25 Mar 2020 · FDA Enforcement Report
Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg recalled
Perrigo Company is recalling Regular Strength Acid Reducer, Ranitidine tablets, USP 75 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-1012-2020
- FDA event ID
- 84127
- Recalling firm
- Perrigo Company, 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
Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 30 tablets per bottle. [NDC: Brand] NDC CVS Health: 69842-293-65; NDC Equaline 41163-931-65; NDC Family Wellness: 55319-876-65; NDC Good Sense 0113-0876-65; NDC H.E.B.: 37808-876-65; NDC Harris Teeter: 69256-876-65; NDC Health Mart: 62011-0283-1; NDC Leader: 62011-0283-1; NDC Major: 0904-6715-46; NDC Signature Care: 21130-118-65; NDC Sunmark: 49348-136-44; NDC Up & Up: 11673-876-65; NDC Walgreens: 0363-1876-65
Where it was distributed
Nationwide USA
Questions about this recall
Is Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg per recalled?
Yes. Perrigo Company recalled Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg per on 23 Oct 2019. The recall is Class II and its status is Terminated. Recall number D-1012-2020.
Why was it recalled?
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Which lots are affected?
Lots: 8DE1363, 8EE1558, 8FE1450, 8GE1331, 8HE1221, 8KE2825, 8JE1916, 8KE2243, 8ME2685, 9AE2785, 9AE2786, 9DE2721, 9CE3317, 9EE2579, 9FE2957, 9GE2785, 9GE3218, 9HE3577
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Perrigo Company
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|---|---|---|---|---|---|
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