The Recall Desk
ModerateFDA (Drugs)·D-0366-2022·Announced 2022-01-19

Metformin 750 mg Extended Release Recalled for NDMA Contamination

RemedyRepack Inc. is recalling Metformin 750 mg Extended Release (NDC # 70518-2920-00) due to detection of N-Nitrosodimethylamine (NDMA) levels exceeding the acceptable daily intake limit. The product was distributed to one direct account in Pennsylvania.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall involving a contaminant (NDMA) detected above acceptable levels. The source text does not report any illnesses, hospitalizations, or injuries. The recall addresses a manufacturing/quality deviation rather than a known safety incident, which aligns with Moderate severity for a precautionary Class II recall.

Plain-English summary

RemedyRepack Inc. is recalling Metformin 750 mg Extended Release tablets (NDC # 70518-2920-00) in 56 blister cards. The recall was issued due to CGMP deviations and the detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.

The affected product includes the following lot numbers and expiration dates: Lot # J0511265-021121 (exp. 02/28/2022), Lot # J0499451-122220 (exp. 01/31/2022), Lot # J0496563-120820 (exp. 12/31/2021), and Lot # J0495111-120120 (exp. 12/31/2021). The product was distributed to one direct account in Pennsylvania.

Consumers who have this medication should stop taking it and contact their healthcare provider or pharmacist for guidance. Healthcare providers should advise patients to return the recalled product.

The recalled product

Product
Metformin 750 mg Extended Release NDC # 70518-2920-00
Manufacturer
RemedyRepack Inc.
Category
Drug — Antidiabetic
Hazard
Affected units
56

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 (5)

  • Lot # J0511265-021121
  • exp. date 02/28/2022 J0499451-122220
  • exp. date 01/31/2022 J0496563-120820
  • exp. date 12/31/2021 J0495111-120120
  • exp. date 12/31/2021

Distribution

Distributed in 1 state:

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