CLASS II Drug recall · Reported 24 Jun 2020 · FDA Enforcement Report
metFORMIN HCL ER USP 500 mg, a) recalled by PD-Rx Pharmaceuticals
PD-Rx Pharmaceuticals is recalling metFORMIN HCL ER USP 500 mg, a) (. The recall was initiated on 5 Jun 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-1307-2020
- FDA event ID
- 85827
- Recalling firm
- PD-Rx Pharmaceuticals, Oklahoma City, OK
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Jun 2020
- FDA classified
- 12 Jun 2020
- Reported
- 24 Jun 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Nitrosamine Impurity
- Drug class
- Diabetes Medication
Timeline
| 5 Jun 2020 | Recall initiated by company | |
| 12 Jun 2020 | Classified by FDA | +7 days |
| 24 Jun 2020 | Published in enforcement report | +12 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) impurity above the acceptable intake level
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 ER USP 500 mg, a) 30 tablets (NDC: 43063-428-30); b) 60 tablets (NDC: 43063-428-60); c) 90 tablets (NDC: 43063-428-90); d) 120 tablets (NDC: 43063-428-98); e) 180 tablets (NDC: 43063-428-93); f) 500 tablets (NDC: 53746-0178-05), Rx only, PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127
Where it was distributed
United States
Questions about this recall
Why was it recalled?
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Which lots are affected?
Lots: a) D19C80, F19C39, H19A55, H19D56, I18E0 Exp. 06/30/2020; b) D19A66, E19C15, F19D60 Exp. 06/30/2020; c) E19D32, J18B83, C19D25, C19E78, D19C60, D19D64, F19B27, G19A31, G19C41, I19A56 Exp. 06/30/2020; d) E19C11, F19E33, I18E07 Exp. 06/30/2020; e) D19D56, F19A51, H19A09, H19A81, H19B16, H19B77, H19C28, I18F43 Exp. 06/30/2020; f) HF06618A, HF06718A Exp. 06/30/2020
Where was it sold?
United States
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 PD-Rx Pharmaceuticals
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|---|---|---|---|---|---|
| Drug | CLASS II | DULoxetine DR USP, 30 mg recalled by PD-Rx Pharmaceuticals | PD-Rx Pharmaceuticals | Nitrosamine Impurity | FL, MS, WI |
| Drug | CLASS II | Simvastatin USP 40 mg recalled by PD-Rx Pharmaceuticals | PD-Rx Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Simvastatin USP 20 mg recalled by PD-Rx Pharmaceuticals | PD-Rx Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Simvastatin USP, 10 mg recalled by PD-Rx Pharmaceuticals | PD-Rx Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Montelukast Sodium USP, 10 mg-bottles recalled by PD-Rx Pharmaceuticals | PD-Rx Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
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 |