CLASS II Drug recall · Reported 31 Oct 2018 · FDA Enforcement Report
Metformin Hydrochloride Extended Release Tablets, 500 mg recalled
Teva Pharmaceuticals U is recalling Metformin Hydrochloride Extended Release Tablets, 500 mg, distributed nationwide in the US. The recall was initiated on 6 Aug 2018 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-0099-2019
- FDA event ID
- 80790
- Recalling firm
- Teva Pharmaceuticals U, North Wales, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Aug 2018
- FDA classified
- 25 Oct 2018
- Reported
- 31 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Diabetes Medication
Timeline
| 6 Aug 2018 | Recall initiated by company | |
| 25 Oct 2018 | Classified by FDA | +80 days |
| 31 Oct 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Product as listed by the FDA
Metformin Hydrochloride Extended Release Tablets, 500 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories, FL Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 00591-2411-01
Where it was distributed
Product was distributed throughout the United States. Bulk product was distributed to Takeda, Deerfield, IL and may have been further distributed.
Questions about this recall
Is Metformin Hydrochloride Extended Release Tablets, 500 mg recalled?
Yes. Teva Pharmaceuticals U recalled Metformin Hydrochloride Extended Release Tablets, 500 mg on 6 Aug 2018. The recall is Class II and its status is Terminated. Recall number D-0099-2019.
Why was it recalled?
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Which lots are affected?
Lot #: 1210888A, Exp 03/2019
Where was it sold?
Product was distributed throughout the United States. Bulk product was distributed to Takeda, Deerfield, IL and may have been further distributed.
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.
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| Drug | CLASS II | Tretinoin Capsules, 10 mg recalled by Teva Pharmaceuticals U | Teva Pharmaceuticals U | Potency & Assay | Nationwide |
| Drug | CLASS II | Doxylamine Succinate and Pyridoxine Hydrochloride recalledDoxylamine Succinate And Pyridoxine Hydrochloride | Teva Pharmaceuticals U | Potency & Assay | Nationwide |
| Drug | CLASS III | Mimvey (estradiol and norethindrone acetate tablets USP) recalledMimvey | Teva Pharmaceuticals U | Labeling Errors | 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 |