CLASS II Drug recall · Reported 24 Jun 2015 · FDA Enforcement Report
Nexium¿ (esomeprazole magnesium), Delayed-Release capsules, 20 mg recalled
AstraZeneca Pharmaceuticals is recalling Nexium¿ (esomeprazole magnesium), Delayed-Release capsules, 20 mg, distributed nationwide in the US. The recall was initiated on 10 Jun 2015 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-1141-2015
- FDA event ID
- 71483
- Recalling firm
- AstraZeneca Pharmaceuticals, Wilmington, DE
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Jun 2015
- FDA classified
- 18 Jun 2015
- Reported
- 24 Jun 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 10 Jun 2015 | Recall initiated by company | |
| 18 Jun 2015 | Classified by FDA | +8 days |
| 24 Jun 2015 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Tablets/Capsules: Confimed customer compliant by a retail pharmacist that an unopened bottle labeled as NEXIUM¿ capsules contained 60 SEROQUEL¿ XR tablets.
Product as listed by the FDA
NEXIUM¿ (esomeprazole magnesium), Delayed-Release capsules, 20 mg, 30-count bottle, Rx only, Manufactured for AstraZeneca LLC, Wilmington, Distributed by AstraZeneca, AB, Sodertalje, Sweden. NDC 00186-5020-31.
Where it was distributed
Nationwide to wholesalers for further distribution at the retail level.
Questions about this recall
Why was it recalled?
Presence of Foreign Tablets/Capsules: Confimed customer compliant by a retail pharmacist that an unopened bottle labeled as NEXIUM¿ capsules contained 60 SEROQUEL¿ XR tablets.
Which lots are affected?
Lot # FC0064; Exp. 05/17
Where was it sold?
Nationwide to wholesalers for further distribution at the retail level.
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.
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