The Recall Desk
SevereFDA (Drugs)·D-0060-2021·Announced 2020-11-11

PD-Rx Recalls Metformin Hydrochloride Extended Release Tablets Due to NDMA

PD-Rx Pharmaceuticals is recalling 125 bottles of Metformin Hydrochloride Extended Release tablets because of NDMA impurity levels above acceptable limits.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving significant impurities like NDMA that may cause adverse health consequences.

Plain-English summary

PD-Rx Pharmaceuticals, Inc. is recalling 125 bottles of Metformin Hydrochloride Extended Release (Metformin HCL ER) 750 mg tablets. The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations involving the detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level, as determined by the manufacturer.

The affected product is distributed in Alaska, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Minnesota, North Carolina, New York, Oklahoma, Oregon, and Wisconsin. The recall includes 30-tablet and 60-tablet packages with specific lot numbers and expiration dates ranging from January 2021 to March 2022.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on alternative treatment options. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
METFORMIN HYDROCHLORIDE EXTENDED RELEASE (METFORMIN HYDROCHLORIDE)
Brand
METFORMIN HYDROCHLORIDE EXTENDED RELEASE
Manufacturer
PD-Rx Pharmaceuticals, Inc.
Category
Drug — Prescription Drug
Hazard
Affected units
125

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (12)

  • Lots: a) A20A97
  • B20D25 Exp. 04/30/21
  • B20D69
  • C20B95
  • C20D60
  • E20A50 Exp. 07/31/21
  • E20D37
  • E20D73 Exp. 03/31/22
  • J19F04 Exp. 01/31/21
  • b) C20C15 Exp. 07/31/21
  • F20A14 Exp. 03/31/22
  • L19C15 Exp. 04/30/21

UPCs (1)

  • 0343063902301

Distribution

Distributed in 16 states:

Part of a larger recall action

This product is one of 2 recalled by PD-Rx Pharmaceuticals, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same brand · METFORMIN HYDROCHLORIDE EXTENDED RELEASE

Same manufacturer · PD-Rx Pharmaceuticals, Inc.

See all →

Same hazard · ndma impurity

See all →