The Recall Desk
SevereFDA (Drugs)·D-0058-2021·Announced 2020-11-11

Direct Rx Recalls Metformin Hydrochloride Extended Release Due to NDMA Impurity

Direct Rx is recalling 88 bottles of Metformin Hydrochloride Extended Release 500 mg in Florida due to NDMA impurity levels above acceptable intake.

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, which corresponds to a Severe severity score under the rubric for significant potential health risks.

Plain-English summary

Direct Rx is recalling 88 bottles of Metformin Hydrochloride Extended Release 500 mg, 90 tablets, distributed in Florida. The recall is due to the detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level, as determined by the manufacturer.

The affected product is identified by Lot 04DE1902 and 11DE1908, with an expiration date of 06/30/2021. The product is packaged and distributed by Direct Rx in Dawsonville, GA.

Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on alternative treatment options.

The recalled product

Product
METFORMIN HYDROCHLORIDE EXTENDED RELEASE (METFORMIN HYDROCHLORIDE)
Brand
METFORMIN HYDROCHLORIDE EXTENDED RELEASE
Manufacturer
Direct Rx
Category
Drug — Prescription Drug
Hazard
Affected units
88

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 (2)

  • Lot: 04DE1902
  • 11DE1908 Exp. 06/30/2021

Distribution

Distributed in 1 state:

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