CLASS II Drug recall · Reported 15 Jan 2020 · FDA Enforcement Report
Ranitidine 150 mg tablets, 24 count bottles recalled
AAA Pharmaceutical is recalling Ranitidine 150 mg tablets, 24 count bottles. The recall was initiated on 26 Dec 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-0645-2020
- FDA event ID
- 84583
- Recalling firm
- AAA Pharmaceutical, Lumberton, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Dec 2019
- FDA classified
- 6 Jan 2020
- Reported
- 15 Jan 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Nitrosamine Impurity
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 26 Dec 2019 | Recall initiated by company | |
| 6 Jan 2020 | Classified by FDA | +11 days |
| 15 Jan 2020 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
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
Ranitidine 150 mg tablets, 24 count bottles, NDC 37808-196-01.
Where it was distributed
Product was distributed to one consignee who may have distributed the product further to their retail stores.
Questions about this recall
Why was it recalled?
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Which lots are affected?
P134458, Sept 2020 P134943, Aug 2020 P135840, Aug, 2020 P136622, April 2021 P136871, April 2021 P137347, April 2021 P137424, April 2021
Where was it sold?
Product was distributed to one consignee who may have distributed the product further to their retail stores.
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
1 other product · FDA event 84583| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Ranitidine 150 mg tablets, 130 count bottles recalled | AAA Pharmaceutical | Nitrosamine Impurity | NJ |
More recalls from AAA Pharmaceutical
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Discount Drug Mart, Allergy Relief recalled by AAA Pharmaceutical | AAA Pharmaceutical | Other | OH |
| Drug | CLASS II | Ranitidine 150 mg tablets, 130 count bottles recalled | AAA Pharmaceutical | Nitrosamine Impurity | NJ |
| Drug | CLASS III | Smart Sense Regular Strength Aspirin Tablets, 325 mg recalled | AAA Pharmaceutical | Other | KS |
Other Ranitidine recalls
All 55| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ranitidine 150 mg, a) 60 Tabs recalled by Direct Rx | Direct Rx | Nitrosamine Impurity | FL, GA |
| Drug | CLASS II | Ranitidine 300 mg, 30 Tabs recalled by Direct Rx | Direct Rx | Nitrosamine Impurity | FL, GA |
| Drug | CLASS II | Ranitidine Tablets, USP, 150 mg x 10 blister card) recalled | American Health Packaging | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Ranitidine Oral Solution, USP, 150 mg/, [ x Dose Cups recalled | Precision Dose | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | ranitidine hydrochloride, USP a) bottles recalled | PD-Rx Pharmaceuticals | Nitrosamine Impurity | 12 states |