CLASS II Drug recall · Reported 21 Oct 2015 · FDA Enforcement Report
Metformin Hydrochloride Extended-Release Tablets, 1000 mg recalled
Actavis Laboratories FL is recalling Metformin Hydrochloride Extended-Release Tablets, 1000 mg, distributed nationwide in the US. The recall was initiated on 25 Sep 2015 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-0014-2016
- FDA event ID
- 72308
- Recalling firm
- Actavis Laboratories FL, Davie, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Sep 2015
- FDA classified
- 13 Oct 2015
- Reported
- 21 Oct 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Diabetes Medication
Timeline
| 25 Sep 2015 | Recall initiated by company | |
| 13 Oct 2015 | Classified by FDA | +18 days |
| 21 Oct 2015 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specifications: Low Out-of-Specification results for the 8 hour timepoint.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
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 USA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA; NDC 0591-2720-60; UPC 3 05912 72060 3.
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications: Low Out-of-Specification results for the 8 hour timepoint.
Which lots are affected?
Lot: 1037736A, Exp 03/18
Where was it sold?
Nationwide and Puerto Rico
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.
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|---|---|---|---|---|---|
| Drug | CLASS III | Ramipril Capsules, USP, 1.25 mg recalled by Actavis Laboratories, FL | Actavis Laboratories FL | Other | Nationwide |
| Drug | CLASS III | Desmopressin Acetate Tablets, 0.1mg recalled by Actavis Laboratories, FL | Actavis Laboratories FL | Other | Nationwide |
| Drug | CLASS III | Cartia XT (diltiazem HCl extended-release capsules, USP) recalled | Actavis Laboratories FL | Other | Nationwide |
| Drug | CLASS II | Diclofenac Sodium and Misoprostol Delayed-Release Tablets recalled | Actavis Laboratories FL | Other | Nationwide |
| Drug | CLASS II | Diclofenac Sodium and Misoprostol Delayed-Release Tablets recalled | Actavis Laboratories FL | Other | 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 |