FlaggedRx← Medication recall checkHome
Class II · ModerateRecall completed

Metformin Hydrochloride Extended Release

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLots: a) A20B02, I19D03, J19A98, K19E32, L19C86 Exp. 12/31/2020; b) I19D55, I19F50, K19A18, K19D87, L19B34, L19D23, L19E74 Exp. 12/31/2020; c) I19E91, I19F33, J19B88, J19E70, K19D26, L19A65 Exp. 12/31/2020; d) I19C21 Exp. 08/21/2020, I19C57, J19C21, J19C67, K19B53, L19C77, L19E44 Exp. 12/31/2020; e) XP9004 Exp. 12/31/2020
Where it was soldUnited States.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byPD-Rx Pharmaceuticals, Inc.
Brand nameMETFORMIN HYDROCHLORIDE EXTENDED RELEASE
Generic nameMETFORMIN HYDROCHLORIDE
Active ingredient(s)METFORMIN HYDROCHLORIDE
Distributed by / forPD-Rx Pharmaceuticals, Inc.
NDC72789-009-30
Show the full FDA record
Full product labelmetFORMIN HCL ER 500 mg, a) 30 tablets (NDC 72789-009-30); b) 60 tablets (NDC 72789-009-60); c) 90 tablets (NDC 72789-009-90); d) 180 tablets (NDC 72789-009-93); e) 100 tablets (NDC 49483-0623-01) bottles, Rx only PD-Rx Pharmaceuticals Incorporated, Oklahoma City, OK 73127
Recalling firmPD-Rx Pharmaceuticals, Inc.
DistributionUnited States.
Quantity1969 bottles
Recall initiated2020-06-05
Report date2020-07-01
Recall completed2021-11-08
Recall numberD-1333-2020
ClassificationClass II
FDA statusTerminated
Origin on fileOklahoma City OK United States

Related

Metformin recallsRecent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.