CLASS II Drug recall · Reported 25 Nov 2020 · FDA Enforcement Report
Metformin HCl Extended Release Tablets USP 500 mg recalled
Preferred Pharmaceuticals is recalling Metformin HCl Extended Release Tablets USP 500 mg, Generic for : Glucophage XR, Pkg Size, distributed in Florida. The recall was initiated on 1 Nov 2020 and the FDA has classified it as Class II.
Check your package
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-0077-2021
- FDA event ID
- 86696
- Recalling firm
- Preferred Pharmaceuticals, Anaheim, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Nov 2020
- FDA classified
- 14 Nov 2020
- Reported
- 25 Nov 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Nitrosamine Impurity
- Drug class
- Diabetes Medication
Timeline
| 1 Nov 2020 | Recall initiated by company | |
| 14 Nov 2020 | Classified by FDA | +13 days |
| 25 Nov 2020 | Published in enforcement report | +11 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: FDA analysis detected 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 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.
Where it was distributed
Distributed to two physician's offices located in FL.
Questions about this recall
Why was it recalled?
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Which lots are affected?
E0620F, Exp.12/31/2021; G2020M Exp., 04/30/2022
Where was it sold?
Distributed to two physician's offices located in FL.
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 Preferred Pharmaceuticals
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|---|---|---|---|---|---|
| Drug | CLASS II | Lidocaine Ointment USP, 5% (Generic for Xylocaine) recalled | Preferred Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | Artificial Tears Lubricant Eye Drops (glycerin recalled | Preferred Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Ondansetron ODT Tablets, USP 4mg, unit dose tablets, Mfg recalled | Preferred Pharmaceuticals | Packaging Defects | CA |
| Drug | CLASS II | Clindamycin Hydrochloride Capsules, USP, 300mg recalled | Preferred Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size recalled | Preferred Pharmaceuticals | Potency & Assay | CA, NV |
Other Metformin recalls
All 58| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Metformin Hydrochloride Extended-Release Tablets 1000mg recalled | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Metformin Hydrochloride Extended- Release 500mg recalledMetformin Hydrochloride | A-S Medication Solutions | Packaging Defects | Nationwide |
| Drug | CLASS II | Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg recalledMetformin Er 500 Mg | Granules Pharmaceuticals | Other | OH |
| Drug | CLASS II | Metformin hydrochloride Extended-Release Tablets, 1000 mg recalled | Teva Pharmaceuticals USA | Nitrosamine Impurity | CA |
| Drug | CLASS II | Metformin Hydrochloride Extended-Release Tablets, USP 750 mg HDPE recalledMetformin Hydrochloride | Viona Pharmaceuticals | Nitrosamine Impurity | NJ |