CLASS II Drug recall · Reported 24 Jun 2020 · FDA Enforcement Report
Metformin Hydrochloride Extended-Release Tablets, USP 500 mg recalled
Apotex is recalling Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, distributed nationwide in the US. The recall was initiated on 27 May 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-1303-2020
- FDA event ID
- 85772
- Recalling firm
- Apotex, North York
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 27 May 2020
- FDA classified
- 12 Jun 2020
- Reported
- 24 Jun 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Nitrosamine Impurity
- Drug class
- Diabetes Medication
Timeline
| 27 May 2020 | Recall initiated by company | |
| 12 Jun 2020 | Classified by FDA | +16 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 acceptable intake levels
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 Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only Manufactured by: Apotex, Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326 NDC 60505-0260-1
Where it was distributed
Nationwide.
Questions about this recall
Is Metformin Hydrochloride Extended-Release Tablets, USP 500 mg recalled?
Yes. Apotex recalled Metformin Hydrochloride Extended-Release Tablets, USP 500 mg on 27 May 2020. The recall is Class II and its status is Completed. Recall number D-1303-2020.
Why was it recalled?
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels
Which lots are affected?
All lots remaining within expiry
Where was it sold?
Nationwide.
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 21 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 Apotex
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|---|---|---|---|---|---|
| Drug | CLASS II | Paxil CR, Paroxetine, Extended-Release Tablets, 5mg recalled by ApotexPaxil | Apotex | Potency & Assay | Nationwide |
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Other Metformin recalls
All 57| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Metformin Hydrochloride Extended-Release Tablets 1000mg recalledMetformin Hydrochloride | Glenmark Pharmaceuticals Inc., U | 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, 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 |
| Drug | CLASS II | Metformin Hydrochloride Extended-Release Tablets, USP 750 mg recalledMetformin Hydrochloride | Viona Pharmaceuticals | Nitrosamine Impurity | Nationwide |