CLASS II Drug recall · Reported 6 Nov 2019 · FDA Enforcement Report
Ranitidine Hydrochloride Capsules 150 mg recalled by AVKARE
AVKARE is recalling Avkare Ranitidine Hydrochloride Capsules 150 mg, distributed in Colorado, Missouri. The recall was initiated on 17 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-0164-2020
- FDA event ID
- 84081
- Recalling firm
- AVKARE, Pulaski, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Oct 2019
- FDA classified
- 28 Oct 2019
- Reported
- 6 Nov 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Nitrosamine Impurity
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 17 Oct 2019 | Recall initiated by company | |
| 28 Oct 2019 | Classified by FDA | +11 days |
| 6 Nov 2019 | 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
AVKARE Ranitidine Hydrochloride Capsules 150 mg 500 Capsules Rx Only NDC 42291-735-50 UPC 342291735507 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Where it was distributed
CO, MO
Questions about this recall
Is Ranitidine Hydrochloride Capsules 150 mg recalled?
Yes. AVKARE recalled Ranitidine Hydrochloride Capsules 150 mg on 17 Oct 2019. The recall is Class II and its status is Terminated. Recall number D-0164-2020.
Why was it recalled?
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Which lots are affected?
Lot 17708 Exp.11/30/2019 Lot 18459 Exp.03/31/2020 Lot 19033 Exp.07/31/2020 Lot 19032 Exp.07/31/2020 Lot 19031 Exp.06/30/2020 Lot 20204 Exp.09/30/2020 Lot 20205 Exp.09/30/2020 Lot 20663 Exp.10/31/2020 Lot 20664 Exp.11/30/2020 Lot 20665 Exp.11/30/2020 Lot 20666 Exp.11/30/2020 Lot 21039 Exp.12/31/2020 Lot 21920 Exp.04/30/2021
Where was it sold?
CO, MO
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.
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Other Avkare ranitidine recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ranitidine Tablets, USP 300 mg recalled by AVKARE | AVKARE | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Ranitidine Tablets, USP 150 mg recalled by AVKARE | AVKARE | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Ranitidine Hydrochloride Capsules 300 mg recalled by AVKARE | AVKARE | Nitrosamine Impurity | CO, MO |