CLASS II Drug recall · Reported 31 Oct 2018 · FDA Enforcement Report
Metformin Hydrochloride Extended Release Tablets 1000 mg recalled
Teva Pharmaceuticals USA is recalling Metformin Hydrochloride Extended Release Tablets 1000 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-0100-2019
- FDA event ID
- 80790
- Recalling firm
- Teva Pharmaceuticals USA, 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 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL, 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 , NDC 00591-2720-60
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
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 #: 1139500A, Exp 04/2019; 1240343A, 1248901M, 1256614M, Exp 05/2020
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 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.
Other products in this recall event
6 other products · FDA event 80790This product is part of a recall event; the main page for the event is Paliperidone Extended Release Tablets 9 mg recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Paliperidone Extended Release Tablets 9 mg recalled | Teva Pharmaceuticals USA | Packaging Defects | Nationwide | |
| CLASS II | Metformin Hydrochloride Extended Release Tablets, 500 mg recalled | Teva Pharmaceuticals USA | Other | Nationwide | |
| CLASS II | Paliperidone Extended Release Tablets 3 mg recalled | Teva Pharmaceuticals USA | Packaging Defects | Nationwide | |
| CLASS II | Fortamet (metformin HCl) extended release tablets, 1000 mg recalled | Teva Pharmaceuticals USA | Other | Nationwide | |
| CLASS II | Actoplus Met XR (Pioglitazone recalled by Teva Pharmaceuticals U | Teva Pharmaceuticals USA | Packaging Defects | Nationwide | |
| CLASS II | Metformin Hydrochloride Extended Release Tablets 1000 mg recalled | Teva Pharmaceuticals USA | Other | Nationwide |
More recalls from Teva Pharmaceuticals USA
All 281| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Metoclopramide Tablets, USP, 5 mg, [100 or 500] Tablets recalledMetoclopramide | Teva Pharmaceuticals USA | Other | Nationwide |
| Drug | CLASS II | traZODone Hydrochloride Tablets, USP, 50 mg recalledTrazodone Hydrochloride | Teva Pharmaceuticals USA | Other | Nationwide |
| Drug | CLASS II | Octreotide Acetate for Injectable Suspension recalledOctreotide Acetate | Teva Pharmaceuticals USA | Sterility | Nationwide |
| Drug | CLASS II | Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) recalledClaravis | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Isotretinoin Capsules, USP, 30 mg recalled by Teva Pharmaceuticals USAIsotretinoin | Teva Pharmaceuticals USA | Potency & Assay | 4 states |
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 |