FlaggedRx← Medication recall checkHome
Class II · ModerateRecall completed

metFORMIN HCL ER USP 500 mg

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

Does this affect you?
Check your lot numberLots: a) D19C80, F19C39, H19A55, H19D56, I18E0 Exp. 06/30/2020; b) D19A66, E19C15, F19D60 Exp. 06/30/2020; c) E19D32, J18B83, C19D25, C19E78, D19C60, D19D64, F19B27, G19A31, G19C41, I19A56 Exp. 06/30/2020; d) E19C11, F19E33, I18E07 Exp. 06/30/2020; e) D19D56, F19A51, H19A09, H19A81, H19B16, H19B77, H19C28, I18F43 Exp. 06/30/2020; f) HF06618A, HF06718A Exp. 06/30/2020
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

Distributed by / forPD-Rx Pharmaceuticals, Inc.
NDC43063-428-30
Show the full FDA record
Full product labelmetFORMIN HCL ER USP 500 mg, a) 30 tablets (NDC: 43063-428-30); b) 60 tablets (NDC: 43063-428-60); c) 90 tablets (NDC: 43063-428-90); d) 120 tablets (NDC: 43063-428-98); e) 180 tablets (NDC: 43063-428-93); f) 500 tablets (NDC: 53746-0178-05), Rx only, PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127
Recalling firmPD-Rx Pharmaceuticals, Inc.
DistributionUnited States
Quantity3703 bottles
Recall initiated2020-06-05
Report date2020-06-24
Recall completed2021-11-08
Recall numberD-1307-2020
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.