CLASS II Drug recall · Reported 31 Mar 2021 · FDA Enforcement Report
Omeprazole Delayed Release Capsules, USP, 20 mg recalled
Golden State Medical Supply is recalling Omeprazole Delayed Release Capsules, USP, 20 mg, distributed in Pennsylvania, Texas. The recall was initiated on 19 Mar 2021 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-0312-2021
- FDA event ID
- 87566
- Recalling firm
- Golden State Medical Supply, Camarillo, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Mar 2021
- FDA classified
- 24 Mar 2021
- Reported
- 31 Mar 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 19 Mar 2021 | Recall initiated by company | |
| 24 Mar 2021 | Classified by FDA | +5 days |
| 31 Mar 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications: Out of Specification results obtained for unknown impurities during stability testing by manufacturer
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
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
Where it was distributed
Sold to two wholesalers/distributors under government contract located in PA and TX
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: Out of Specification results obtained for unknown impurities during stability testing by manufacturer
Which lots are affected?
Lot #: GS029673, Exp. Date 5/2021
Where was it sold?
Sold to two wholesalers/distributors under government contract located in PA and TX
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.
More recalls from Golden State Medical Supply
All 55| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Prasugrel HCI, Tablets, USP, 10mg recalledPrasugrel | Golden State Medical Supply | Potency & Assay | Nationwide |
| Drug | CLASS II | Carbamazepine Tablets, USP, 200mg recalledCarbamazepine | Golden State Medical Supply | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Gsms Incorporated, Niacin Extended-release Tablets, USP, 1,000 MG recalledNiacin | Golden State Medical Supply | Potency & Assay | CA |
| Drug | CLASS III | Primidone Tablets, USP, 250 mg recalled by Golden State Medical SupplyPrimidone | Golden State Medical Supply | Other | Nationwide |
| Drug | CLASS III | Primidone Tablets, USP, 50 mg recalled by Golden State Medical SupplyPrimidone | Golden State Medical Supply | Other | Nationwide |
Other Omeprazole recalls
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Omeprazole Delayed-release Capsules, USP, 20mg recalledOmeprazole | Dr. Reddy's Laboratories | Other | Nationwide |
| Drug | CLASS II | Omeprazole and Sodium Bicarbonate For Oral Suspension recalled | Bausch Health Companies | Potency & Assay | Nationwide |
| Drug | CLASS II | Omeprazole Delayed-Release Capsules, 20 mg* recalledAcid Reducer | Dr. Reddy's Laboratories | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Prilosec (Omeprazole Magnesium) For Delayed-Release Oral recalledPrilosec | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | Omeprazole Delayed-Release Capsules, USP, 20 mg recalled | Breckenridge Pharmaceutical | Potency & Assay | Nationwide |