CLASS II Drug recall · Reported 15 Jan 2020 · FDA Enforcement Report
Ranitidine Capsules 300 mg recalled by Appco Pharma
Appco Pharma is recalling Ranitidine Capsules 300 mg. The recall was initiated on 7 Jan 2020 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-0648-2020
- FDA event ID
- 84610
- Recalling firm
- Appco Pharma, Piscataway, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Jan 2020
- FDA classified
- 7 Jan 2020
- Reported
- 15 Jan 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Nitrosamine Impurity
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 7 Jan 2020 | Recall initiated by company | |
| 7 Jan 2020 | Classified by FDA | +0 days |
| 15 Jan 2020 | Published in enforcement report | +8 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 Capsules 300 mg, 30 count bottles. Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623, NDC 62559-691-30.
Where it was distributed
Product was distributed to 6 major distributors/wholesalers some with multiple locations who may have further distribute the product.
Questions about this recall
Is Ranitidine Capsules 300 mg recalled?
Yes. Appco Pharma recalled Ranitidine Capsules 300 mg on 7 Jan 2020. The recall is Class II and its status is Terminated. Recall number D-0648-2020.
Why was it recalled?
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Which lots are affected?
Batch # 1905227UE, exp. date Apr-2021 1905228UE, exp. date Apr-2021
Where was it sold?
Product was distributed to 6 major distributors/wholesalers some with multiple locations who may have further distribute the product.
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 Appco Pharma
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Prazosin Hydrochloride Capsules, USP, 5mg recalled by Appco PharmaPrazosin Hydrochloride | Appco Pharma | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Prazosin Hydrochloride Capsules, USP, 2mg recalled by Appco PharmaPrazosin Hydrochloride | Appco Pharma | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Prazosin Hydrochloride Capsules, USP, 1mg recalled by Appco PharmaPrazosin Hydrochloride | Appco Pharma | Nitrosamine Impurity | Nationwide |
| Drug | CLASS III | Venlafaxine Extended-Release Tablets, 150mg recalled by Appco PharmaVenlafaxine | Appco Pharma | Other | Nationwide |
| Drug | CLASS II | Ranitidine Capsules 150 mg, (a) bottles recalled by Appco Pharma | Appco Pharma | Nitrosamine Impurity | NJ |
Other Ranitidine recalls
All 34| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 Tablets, USP 300 mg a) recalled by Denton Pharma | Denton Pharma | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Ranitidine Tablets, USP 150 mg , a) recalled by Denton Pharma | Denton Pharma | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Ranitidine Capsules 150 mg, (a) bottles recalled by Appco Pharma | Appco Pharma | Nitrosamine Impurity | NJ |