Food, drugs, devices › SUN PHARMACEUTICAL INDUSTRIES INC
Drug recall: Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm Laborat
SUN PHARMACEUTICAL INDUSTRIES INC (Princeton, NJ) initiated this drug recall on 21 Jun 2022; FDA lists 2 product records under event 90891, classified Class III.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 18% of the 325 drug enforcement events initiated in 2022 carry the same class.
Status: Terminated, terminated 11 Aug 2023. Initiation: voluntary: firm initiated. SUN PHARMACEUTICAL INDUSTRIES INC has 94 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
SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ.
Reason for recall
"Superpotent Drug: Out of specification for assay at the 12-month timepoint."
Distribution
"Nationwide in the USA"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0004-2023 | Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-734-90. | 5712 bottles | Class III | Terminated | 5 Oct 2022 |
| D-0005-2023 | Esomeprazole Magnesium Delayed-Release Capsules, USP, 40mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-735-90. | 8640 bottles | Class III | Terminated | 5 Oct 2022 |
Context
Other enforcement events for SUN PHARMACEUTICAL INDUSTRIES INC
All 94 events for SUN PHARMACEUTICAL INDUSTRIES INC
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Superpotent Drug: Out of specification for assay at the 12-month timepoint."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide in the USA"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 11 Aug 2023. "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.