CLASS III Drug recall · Reported 5 Oct 2022 · FDA Enforcement Report
Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg recalled
SUN Pharmaceutical Industries is recalling Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, distributed nationwide in the US. The recall was initiated on 21 Jun 2022 and the FDA has classified it as Class III.
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-0004-2023
- FDA event ID
- 90891
- Recalling firm
- SUN Pharmaceutical Industries, Princeton, NJ
- Manufacturer
- Sun Pharmaceutical Industries, Inc
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 21 Jun 2022
- FDA classified
- 6 Oct 2022
- Reported
- 5 Oct 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 21 Jun 2022 | Recall initiated by company | |
| 5 Oct 2022 | Published in enforcement report | +106 days |
| 6 Oct 2022 | Classified by FDA | +1 day |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Which lots are affected?
Lot AC14299, Exp 12/2022
Where was it sold?
Nationwide in the USA
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
Other products in this recall event
1 other product · FDA event 90891| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Esomeprazole Magnesium Delayed-Release Capsules, USP, 40mg recalledEsomeprazole Magnesium | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
More recalls from SUN Pharmaceutical Industries
All 138| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Carbamazepine Tablets, USP, 200mg recalled | SUN Pharmaceutical Industries | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine recalled | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Perampanel CIII Tablets, 6mg recalled by Sun Pharmaceutical IndustriesPerampanel | SUN Pharmaceutical Industries | Packaging Defects | Nationwide |
| Drug | CLASS I | DOXOrubin Hydrochloride Liposome injection, 50 mg recalledDoxorubicin Hydrochloride | SUN Pharmaceutical Industries | Particulate Matter | Nationwide |
| Drug | CLASS II | Budesonide Inhalation Suspension, 1mg recalledBudesonide | SUN Pharmaceutical Industries | Particulate Matter | Nationwide |
Other Esomeprazole recalls
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Esomeprazole Magnesium for Delayed-Release Oral Suspension recalledEsomeprazole Magnesium | Zydus Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Esomeprazole Magnesium for Delayed-Release Oral Suspension recalledEsomeprazole Magnesium | Zydus Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Esomeprazole Magnesium for Delayed-Release Oral Suspension recalledEsomeprazole Magnesium | Zydus Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS III | Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg recalledEsomeprazole Magnesium | Glenmark Pharmaceuticals Inc., USA | Potency & Assay | Nationwide |
| Drug | CLASS III | Esomeprazole Magnesium Delayed-Release Capsules, USP, 40mg recalledEsomeprazole Magnesium | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |