Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 90 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-339-09

Class I - Dangerous

💊 Drugs Recalled: July 7, 2020 Lupin Pharmaceuticals Prescription Drugs

What Should You Do?

Check if you have this product:
Batch # G807093 Jul-20 G807147 Jul-20 G807208 Jul-20 G807479 Jul-20 G807480 Jul-20 G807830 Jul-20 G807092 Jul-20 G809471 Jul-20 G808155 Aug-20 G808074 Aug-20 G808115 Aug-20 G900231 Nov-20 G900232 Nov-20 G903277 Mar-21 G903278 Mar-21 G903279 Mar-21 G903280 Mar-21 G903281 Mar-21 G903818 Apr-21 G904048 Apr-21 G904164 Apr-21 G906548 Jul-21 G907239 Aug-21 G907255 Aug-21 G907256 Aug-21 G907263 Aug-21 G001802 Jan-22 G001804 Jan-22 G001803 Jan-22 G001805 Jan-22 G001806 Jan-22 G001807 Jan-22 G001808 Jan-22 G808154 Aug-20 G900227 Nov-20 G900228 Nov-20 G900229 Nov-20 G900230 Nov-20 G906549 Jul-21 G906550 Jul-21 G906547 Jul-21 G907279 Aug-21 G907364 Aug-21 G001809 Jan-22 G001801 Jan-22 G002563 Feb-22 G002564 Feb-22
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:: Lupin Pharmaceuticals Inc.
Reason for Recall:: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 90 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-339-09

Product Codes/Lot Numbers:

Batch # G807093 Jul-20 G807147 Jul-20 G807208 Jul-20 G807479 Jul-20 G807480 Jul-20 G807830 Jul-20 G807092 Jul-20 G809471 Jul-20 G808155 Aug-20 G808074 Aug-20 G808115 Aug-20 G900231 Nov-20 G900232 Nov-20 G903277 Mar-21 G903278 Mar-21 G903279 Mar-21 G903280 Mar-21 G903281 Mar-21 G903818 Apr-21 G904048 Apr-21 G904164 Apr-21 G906548 Jul-21 G907239 Aug-21 G907255 Aug-21 G907256 Aug-21 G907263 Aug-21 G001802 Jan-22 G001804 Jan-22 G001803 Jan-22 G001805 Jan-22 G001806 Jan-22 G001807 Jan-22 G001808 Jan-22 G808154 Aug-20 G900227 Nov-20 G900228 Nov-20 G900229 Nov-20 G900230 Nov-20 G906549 Jul-21 G906550 Jul-21 G906547 Jul-21 G907279 Aug-21 G907364 Aug-21 G001809 Jan-22 G001801 Jan-22 G002563 Feb-22 G002564 Feb-22