The Recall Desk
SevereFDA (Drugs)·D-0059-2021·Announced 2020-11-11

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

PD-Rx Pharmaceuticals is recalling 1,683 bottles of Metformin Hydrochloride Extended Release 500 mg 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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or specific high-risk impurities like NDMA (which is a probable human carcinogen) are categorized as Severe (Score 4), as they are not Class I but involve serious potential health risks.

Plain-English summary

PD-Rx Pharmaceuticals, Inc. is recalling 1,683 bottles of Metformin Hydrochloride Extended Release 500 mg. The recall involves four package sizes: 30, 60, 90, and 180 tablets. The product is a prescription-only medication distributed in Alaska, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Minnesota, North Carolina, New York, Oklahoma, Oregon, and Wisconsin.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the manufacturer detected the impurity N-Nitrosodimethylamine (NDMA) at levels above the acceptable intake limit. The affected lots include specific expiration dates ranging from July 31, 2021, to April 30, 2022.

Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for guidance on alternative treatments. The FDA has classified this recall as Class II, indicating a situation where 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 Medication
Hazard
Affected units
1,683

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 (20)

  • Lots: a) B20D23
  • B20D67 Exp. 07/31/21
  • C20D55 Exp. 12/31/21
  • b) A20D92
  • A20F59
  • B20C16 Exp. 07/31/21
  • C20D63
  • D20A45
  • D20C80 Exp. 12/31/21
  • G20D46
  • I20C57 Exp. 04/30/22
  • c) A20D90
  • A20E77
  • A20F69
  • B20F43 Exp. 07/31/21
  • C20B14
  • D20A41 Exp. 12/31/21
  • I20D94
  • I20E56
  • J20A28 Exp. 04/30/22

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 →