Stop using now Drug recall · FDA · Published June 17, 2020

Preferred Pharmaceuticals recalls Metformin XR tablets with NDMA levels above safety limit

Preferred Pharmaceuticals recalls 100-count Metformin HCl Extended Release Tablets due to detected N-Nitrosodimethylamine (NDMA) levels exceeding FDA safety limits. Consumers should stop using affected products immediately.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-1364-2020Drug Preferred Pharmaceuticals ›

Stop using this now

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.

Take action

Contact the company

Recalling firmPreferred Pharmaceuticals, Inc.1250 N Lakeview Ave Ste O · Anaheim, CA 92807-1801

✎ GovInfoNow plain-language explainer

Preferred Pharmaceuticals is recalling 100-count Metformin HCl Extended Release Tablets (Glucophage XR) because FDA testing found N-Nitrosodimethylamine (NDMA) levels above the acceptable daily intake limit. This could pose a health risk with long-term use, though the recall does not indicate immediate harm to current users. Read more at govinfonow.com/recall/37043-preferred-pharmaceuticals-recalls-metformin-xr-tablets-with-ndma-levels-above.

Source Summary by GovInfoNow · govinfonow.com/recall/37043-preferred-pharmaceuticals-recalls-metformin-xr-tablets-with-ndma-levels-above · Updated October 5, 2026 · FDA enforcement record: FDA #D-1364-2020

Cite this page

“Preferred Pharmaceuticals recalls Metformin XR tablets with NDMA levels above safety limit.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37043-preferred-pharmaceuticals-recalls-metformin-xr-tablets-with-ndma-levels-above. Based on FDA recall #D-1364-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1364-2020%22&limit=1).

The FDA announced on June 17, 2020, that Preferred Pharmaceuticals is recalling Metformin HCl Extended Release Tablets due to CGMP deviations detected by the agency. FDA analysis found N-Nitrosodimethylamine (NDMA) levels exceeding the Acceptable Daily Intake Limit in the product.

How to tell if you have it

Brand: Preferred Pharmaceuticals
Product: Metformin HCl Extended Release Tablets, USP, 500 mg, Generic for Glucophage XR
Pkg Size: 100
Mfg: Time-Cap, Labs Inc.
NDC: 68788-6932-01
Lot Codes: J0119M, K1419L, K2719J, A0220H
Exp. Date: 12/2020
Distribution: Two medical clinics in FL
Units: 144 bottles

The hazard

FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit. The recall is classified as a Class II voluntary recall initiated by the firm.

Context

GovInfoNow's records show Preferred Pharmaceuticals, Inc. has 32 other recalls on record since August 15, 2018. Other recent recalls of similar products include Preferred Pharma Recalls Lidocaine Ointment Due to Content Issues (September 28, 2026), Geri-Care Eye Drops Recalled for Sterility Risk (March 25, 2026), and Preferred Pharma Recalls Ondansetron ODT Due to Defective Seals (November 17, 2025). Other recent recalls of similar products include Cipla Cinacalcet Tablets Recall: N-nitroso-cinacalcet Over Daily Intake Limit (June 29, 2026), Cipla Cinacalcet Tablets Recall: N-Nitroso Contamination Risk (March 16, 2026), and Zydus Erythromycin Tablets Recall: N-Nitroso-Desmethyl-Erythromycin Risk (April 29, 2026).

How to tell if you have this one

Check for the product name 'Metformin HCl Extended Release Tablets, USP, 500 mg, Generic for Glucophage XR' on the packaging. The package size is 100 tablets, manufactured by Time-Cap Labs Inc. in Farmingdale, NY, with NDC code 68788-6932-01.

Brand
Preferred Pharmaceuticals
Category
Drug

Based on the official FDA remedy

What to do — step by step

Stop using it now
Immediately stop taking the recalled Metformin HCl Extended Release Tablets (Glucophage XR) and contact your healthcare provider for alternative treatment options.

Where it went and when

Where it was distributed

Distributed in Florida.

FDA distribution: “Product was distributed to two medical clinics located in FL.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Florida.

Recall timeline

FDA terminated this recall 3.8 years after the firm started it.

Jun 17, 2020Firm started the recall
Jun 26, 2020FDA classified it Class II
Jul 8, 2020Published in FDA’s Enforcement Report
Mar 21, 2024FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Other Preferred Pharmaceuticals recalls

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Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/37043-preferred-pharmaceuticals-recalls-metformin-xr-tablets-with-ndma-levels-above">Preferred Pharmaceuticals recalls Metformin XR tablets with NDMA levels above safety limit (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-1364-2020 (June 17, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1364-2020 to see it in context.
Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.