Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Omeprazole Delayed-Release Capsules Recalled by Breckenridge Pharmaceutical, Inc Due to Failed Impurities/Degradation Specifications: Out-of-Specification results obtained for unknown...

Date: March 11, 2021
Company: Breckenridge Pharmaceutical, Inc
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Breckenridge Pharmaceutical, Inc directly.

Affected Products

Omeprazole Delayed-Release Capsules, USP, 20 mg, 1000 count bottles, Rx Only, distributed by Breckenridge Pharmaceutical, Inc., Berlin, CT, Manufactured by Tow Pharmaceutical Europe, S.L., Martorelles (Barcelona), Spain NDC 51991-643-10

Quantity: 3,146 bottles

Why Was This Recalled?

Failed Impurities/Degradation Specifications: Out-of-Specification results obtained for unknown impurities during stability testing.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Breckenridge Pharmaceutical, Inc

Breckenridge Pharmaceutical, Inc has 20 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report