Metformin HCL Extended-Release (PD-Rx) – NDMA Impurity (2020)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
metFORMIN 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
Brand
PD-Rx Pharmaceuticals, Inc.
Lot Codes / Batch Numbers
Lots: 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
Products Sold
Lots: 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
PD-Rx Pharmaceuticals, Inc. is recalling metFORMIN HCL ER 500 mg, a) 30 tablets (NDC 72789-009-30); b) 60 tablets (NDC 72789-009-60); c) 90 t due to CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026