Food, drugs, devices › AstraZeneca Pharmaceuticals LP
Drug recall: NEXIUM¿ (esomeprazole magnesium), Delayed-Release capsules, 20 mg, 30-count bottle, Rx only, Manufactured for AstraZenec
AstraZeneca Pharmaceuticals LP (Wilmington, DE) initiated this drug recall on 10 Jun 2015; FDA lists 1 product record under event 71483, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 52% of the 292 drug enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 27 Sep 2016. Initiation: voluntary: firm initiated. AstraZeneca Pharmaceuticals LP has 5 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
AstraZeneca Pharmaceuticals LP, Wilmington, DE.
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."
Distribution
"Nationwide to wholesalers for further distribution at the retail level."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1141-2015 | 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. | 34,524 bottles | Class II | Terminated | 24 Jun 2015 |
Context
Other enforcement events for AstraZeneca Pharmaceuticals LP
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 23 Feb 2018 | Lynparza (olaparib) capsules 50 mg, 112 count bottles, Rx only, Manufactured for: Astra Zeneca Pharmaceuticals LP Wilmin | Drug | Class III | 1 |
| 25 May 2017 | BRILINTA (ticagrelor) tablets, 90 mg, 8-count Professional Sample bottles, Rx only, Mfd. for: AstraZeneca Pharmaceutical | Drug | Class I | 1 |
| 5 Feb 2016 | Tudorza Pressair (aclindinium bromide inhalation powder), 400 mcg per actuation, 60 Metered Doses per Inhaler, Rx Only. | Drug | Class II | 1 |
| 21 Jun 2013 | MERREM I.V. (meropenem for injection), 1 g meropenem equivalent, 30 mL vial, Rx only, Mfd for: AstraZeneca Pharmaceutica | Drug | Class II | 1 |
All 5 events for AstraZeneca Pharmaceuticals LP
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide to wholesalers for further distribution at the retail level."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 27 Sep 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.