The Recall Desk
ModerateFDA (Drugs)·D-0026-2022·Announced 2021-10-27

Omeprazole Magnesium Acid Reducer Capsules Recalled for Staple Contamination

Dr. Reddy's Laboratories is recalling Acid Reducer (Omeprazole Magnesium) 20 mg capsules nationwide because staples have been found co-mingled with capsules in bottles.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall involving a manufacturing defect (staple contamination). No reported illnesses or injuries are stated in the source text. The hazard is a foreign object contamination, which is a documented quality control deviation but without evidence of actual harm or hospitalization, placing it in the Moderate category.

Plain-English summary

Dr. Reddy's Laboratories, Inc. is recalling Acid Reducer (Omeprazole Magnesium) Delayed-Release Capsules, 20 mg, 24-hour strength, in 14-count bottles. The recall was initiated due to a customer complaint reporting the presence of a staple co-mingled with capsules within the bottle, indicating a manufacturing defect.

The affected product was distributed nationwide in the USA. The recalled product is identified by the batch code BT001594C, NDC 70000-0232-1, and approximately 8,976 bottles are involved in this recall. The product was distributed by Cardinal Health, Dublin, OH.

Consumers who have purchased this product and have the affected batch code should not use it and should contact Dr. Reddy's Laboratories or a healthcare provider if they have questions or concerns.

The recalled product

Product
ACID REDUCER (OMEPRAZOLE MAGNESIUM)
Brand
ACID REDUCER
Manufacturer
Dr. Reddy's Laboratories, Inc.
Hazard
  • foreign-object-contamination
  • staple-in-capsules
  • manufacturing-defect

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 (1)

  • BT001594C

Distribution

Distributed nationwide across the United States.