The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0077-2021·Announced 2020-11-25

Preferred Pharmaceuticals Recalls Metformin HCl Extended Release Tablets Due to NDMA

Preferred Pharmaceuticals is recalling 99 bottles of Metformin HCl Extended Release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) levels exceeding the Acceptable Daily Intake Limit.

The agency’s classification

FDA (Drugs): Class II

Class II is 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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II, and the rubric specifies that FDA Class II recalls involving significant injury/property-damage reports or structural defects are Severe. While no specific injuries are reported, the presence of NDMA above the ADI limit in a Class II drug recall aligns with the Severe criteria for significant potential harm.

Plain-English summary

Preferred Pharmaceuticals, Inc. is recalling 99 bottles (9,990 tablets) of Metformin HCl Extended Release Tablets USP 500 mg. The product is a generic for Glucophage XR, manufactured by Time-Cap Labs, Inc. in Farmingdale, NY, under NDC #68788-6932-1.

The recall was initiated because FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit. This constitutes a Current Good Manufacturing Practice (CGMP) deviation. The affected lots include E0620F with an expiration date of 12/31/2021, and G2020M with an expiration date of 04/30/2022.

The affected product was distributed to two physician's offices located in Florida. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Metformin HCl Extended Release Tablets USP 500 mg, Generic for : Glucophage XR, Pkg Size 100, Mfg: Time-Cap Labs, Inc.; Farmingdale, NY, NDC #: 68788-6932-1, Preferred Pharmaceuticals, Inc.
Manufacturer
Preferred Pharmaceuticals, Inc.
Category
Drug — Prescription Medication
Hazard

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 (4)

  • E0620F
  • Exp.12/31/2021
  • G2020M Exp.
  • 04/30/2022

Distribution

Distributed in 1 state:

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