CLASS II ONGOING Drug recall · Reported 11 Dec 2019 · FDA Enforcement Report
Zantac 75 mg recalled by Sanofi-Aventis U.S
Sanofi-Aventis U.S is recalling Zantac 75 mg, distributed nationwide in the US. The recall was initiated on 22 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-0545-2020
- FDA event ID
- 84122
- Recalling firm
- Sanofi-Aventis U.S, Bridgewater, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Oct 2019
- FDA classified
- 1 Dec 2019
- Reported
- 11 Dec 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Nitrosamine Impurity
Timeline
| 22 Oct 2019 | Recall initiated by company | |
| 1 Dec 2019 | Classified by FDA | +40 days |
| 11 Dec 2019 | Published in enforcement report | +10 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: Presence of NDMA impurity detected in product.
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
Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 0597-0122-01 0597-0122-08 0597-0122-13 0597-0122-37 0597-0122-40 0597-0122-54 0597-0122-61 0597-0122-81 0597-0122-96
Where it was distributed
Nationwide
Questions about this recall
Is Zantac 75 mg recalled?
Yes. Sanofi-Aventis U.S recalled Zantac 75 mg on 22 Oct 2019. The recall is Class II and its status is Ongoing. Recall number D-0545-2020.
Why was it recalled?
CGMP Deviations: Presence of NDMA impurity detected in product.
Which lots are affected?
all lots
Where was it sold?
Nationwide
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 Sanofi-Aventis U.S
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Admelog, insulin lispro injection/mL (U-100) multi-dose vial recalledAdmelog | Sanofi-Aventis U.S | Sterility | Nationwide |
| Drug | CLASS II | Elitek (rasburicase) for injection, 5 mg vial recalledElitek | Sanofi-Aventis U.S | Potency & Assay | Nationwide |
| Drug | CLASS II | Regular Strength Zantac 150 mg recalled by Sanofi-Aventis U.S | Sanofi-Aventis U.S | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Regular Strength Zantac 150 mg recalled by Sanofi-Aventis U.S | Sanofi-Aventis U.S | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Regular Strength Zantac 75 mg recalled by Sanofi-Aventis U.S | Sanofi-Aventis U.S | Nitrosamine Impurity | Nationwide |