The Recall Desk
SevereFDA (Drugs)·D-0312-2021·Announced 2021-03-31

Golden State Medical Supply Recalls Omeprazole Capsules Due to Impurities

Golden State Medical Supply is recalling Omeprazole Delayed Release Capsules because stability testing revealed unknown impurities.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II, which corresponds to a Severe severity score according to the rubric.

Plain-English summary

Golden State Medical Supply Inc. is recalling Omeprazole Delayed Release Capsules, USP, 20 mg, 1000-count bottles. The product is prescription-only and is identified by NDC 51407-129-10. The specific lot affected is GS029673, with an expiration date of 5/2021.

The recall was initiated because the manufacturer obtained out-of-specification results for unknown impurities during stability testing. This indicates that the product failed to meet required impurities and degradation specifications.

The affected product was sold to two wholesalers and distributors located in Pennsylvania and Texas under government contract. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for guidance on replacement or return.

The recalled product

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

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #: GS029673
  • Exp. Date 5/2021

Distribution

Distributed in 2 states: