Why it was recalled
Discoloration: product contains brown pellets
Product description
Esomeprazole Magnesium Delayed Release Capsules USP, 40 mg*, 1000-count bottles, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 INDIA, NDC 43598-510-10
Lot numbers, UPCs & expiration codes
Lot #: C900642, Exp. 06/2020
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1256-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 24, 2020
- FDA report date
- May 6, 2020
- Quantity
- 1752 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-1256-2020, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 85557
- Address
- 107 College Rd E
- Code information
- Lot #: C900642, Exp. 06/2020
- Postal code
- 08540-6623
- Report date
- May 6, 2020
- Product type
- Drugs
- Recall number
- D-1256-2020
- Classification
- Class III
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- 1752 bottles
- Termination date
- May 13, 2022
- Reason for recall
- Discoloration: product contains brown pellets
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Esomeprazole Magnesium Delayed Release Capsules USP, 40 mg*, 1000-count bottles, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 INDIA, NDC 43598-510-10
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Apr 24, 2020
- Initial firm notification
- Letter
- Center classification date
- Apr 28, 2020