FDA Drug recall D-0312-2021
Omeprazole Delayed Release Capsules, USP, 20 mg, 1000-count bottles, Rx only, Packaged by GSMS Incorporated, Camarillo, CA 93012-8601 USA,…
- FDA Drug
- Class II
- terminated
- Published 2021-03-31
On 2021-03-31 the FDA classified a Class II recall of Omeprazole Delayed Release Capsules, USP, 20 mg, 1000-count bottles, Rx only, Packaged by GSMS Incorporated, Camarillo, CA 93012-8601 USA,… by Golden State Medical Supply, citing failed Impurities/Degradation Specifications: Out of Specification results obtained for unknown impurities during stability testing by manufacturer.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0312-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-03-19 |
| Published | 2021-03-31 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Golden State Medical Supply |
| Distribution | PA, TX |
Product
Omeprazole Delayed Release Capsules, USP, 20 mg, 1000-count bottles, Rx only, Packaged by GSMS Incorporated, Camarillo, CA 93012-8601 USA, NDC 51407-129-10
Reason
Failed Impurities/Degradation Specifications: Out of Specification results obtained for unknown impurities during stability testing by manufacturer
Identifiers
| code_info | Lot #: GS029673, Exp. Date 5/2021 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0312-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.