CLASS II Drug recall · Reported 19 Jan 2022 · FDA Enforcement Report

Metformin 750 mg Extended Release recalled by RemedyRepack

RemedyRepack is recalling Metformin 750 mg Extended Release, distributed in Pennsylvania. The recall was initiated on 30 Dec 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # 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

Quantity recalled56 Blister Cards

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0366-2022
FDA event ID: 89331
Recalling firm: RemedyRepack, Indiana, PA
Classification: Class II
Status: Terminated
Recall initiated: 30 Dec 2021
FDA classified: 11 Jan 2022
Reported: 19 Jan 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Nitrosamine Impurity
Drug class: Diabetes Medication

Timeline

30 Dec 2021	Recall initiated by company
11 Jan 2022	Classified by FDA	+12 days
19 Jan 2022	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Nitrosamines are impurities that can form during drug manufacturing or storage. Above the FDA acceptable intake limit, long-term exposure may raise cancer risk. The FDA advises patients to keep taking the medicine until they have a replacement.

Product as listed by the FDA

Metformin 750 mg Extended Release NDC # 70518-2920-00

Where it was distributed

Product was distributed to one direct account in PA.

Pennsylvania

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

Product was distributed to one direct account in PA.

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from RemedyRepack

All 61

Reported	Class	Recall	Company	Reason	Where
14 May 2025Drug	CLASS II	Clindamycin HCl Capsule, 300 mg, QTY recalled by RemedyRePack	RemedyRePack	Manufacturing (CGMP) Deviations	FL, PA, VA
30 Apr 2025Drug	CLASS II	Clindamycin HCl, QTY recalled by RemedyRepack	RemedyRepack	Manufacturing (CGMP) Deviations	PA
12 Feb 2025Drug	CLASS II	Carvedilol, QTY: per Blister Pack ( blister cards) recalled	RemedyRepack	Nitrosamine Impurity	FL
1 Jan 2025Drug	CLASS II	Duloxetine Delayed-Release Capsules, 60 mg, a) blister cards recalled	RemedyRepack	Nitrosamine Impurity	Nationwide
24 Jul 2024Drug	CLASS II	Potassium Chloride Micro 10mEq recalled by RemedyRepack	RemedyRepack	Potency & Assay	Nationwide

Other Metformin recalls

All 58

Reported	Class	Recall	Company	Reason	Where
16 Apr 2025Drug	CLASS II	Metformin Hydrochloride Extended-Release Tablets 1000mg recalled	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
2 Apr 2025Drug	CLASS II	Metformin Hydrochloride Extended- Release 500mg recalledMetformin Hydrochloride	A-S Medication Solutions	Packaging Defects	Nationwide
15 Jan 2025Drug	CLASS II	Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg recalledMetformin Er 500 Mg	Granules Pharmaceuticals	Other	OH
15 Mar 2023Drug	CLASS II	Metformin hydrochloride Extended-Release Tablets, 1000 mg recalled	Teva Pharmaceuticals USA	Nitrosamine Impurity	CA
2 Feb 2022Drug	CLASS II	Metformin Hydrochloride Extended-Release Tablets, USP 750 mg HDPE recalledMetformin Hydrochloride	Viona Pharmaceuticals	Nitrosamine Impurity	NJ