Esomeprazole Magnesium Delayed-Release Capsules, USP 40 mg, packaged in Unit Dose Blister Cards of 6 (10 cards of 6 Capsules each per carton), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC 42292-010-16
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot #: 3110437, 3111409, 3110785, Exp. Date 7/31/2022; 3112173, Exp. Date 11/30/2022
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Reason for Recall:
- Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Esomeprazole Magnesium Delayed-Release Capsules, USP 40 mg, packaged in Unit Dose Blister Cards of 6 (10 cards of 6 Capsules each per carton), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC 42292-010-16
Product Codes/Lot Numbers:
Lot #: 3110437, 3111409, 3110785, Exp. Date 7/31/2022; 3112173, Exp. Date 11/30/2022
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0861-2022
Related Recalls
Esomeprazole Magnesium Delayed-Release Capsules, USP 20 mg, packaged in Unit Dose Blister Cards of 6 (10 cards of 6 Capsules each per carton), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC 42292-009-16
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.
Alprazolam Tablets, USP, 0.25 mg, 10x10 per carton, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 51079-788-20
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Failed Impurities/Degradation Specifications: Elevated levels of a known impurity detected during 6-month RT stability interval.
Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister cards of 10 capsules each per carton, Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV. NDC 51079-947-08
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Failed Impurities/Degradation Specifications; out of specification results for related compound per the manufacturer