CLASS III Drug recall · Reported 7 Oct 2020 · FDA Enforcement Report
Metformin Hydrochloride Tablets USP, 1000 mg recalled
Legacy Pharmaceutical Packaging is recalling Metformin Hydrochloride Tablets USP, 1000 mg, distributed in Arkansas, Georgia. The recall was initiated on 24 Sep 2020 and the FDA has classified it as Class III.
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-1626-2020
- FDA event ID
- 86471
- Recalling firm
- Legacy Pharmaceutical Packaging, Earth City, MO
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 24 Sep 2020
- FDA classified
- 30 Sep 2020
- Reported
- 7 Oct 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Drug class
- Diabetes Medication
Timeline
| 24 Sep 2020 | Recall initiated by company | |
| 30 Sep 2020 | Classified by FDA | +6 days |
| 7 Oct 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Tablets/Capsules: Metformin 1000mg with different imprint was found in bottles.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Metformin Hydrochloride Tablets USP, 1000 mg, 60-count bottles, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045, Distributed by: Wal-Mart, Bentonville, AR 72716. NDC 68645-545-59
Where it was distributed
Walmart distribution centers in GA and AR
Stores named: Walmart
Questions about this recall
Why was it recalled?
Presence of Foreign Tablets/Capsules: Metformin 1000mg with different imprint was found in bottles.
Which lots are affected?
Lot #: 201626, Exp. Date 08/2022
Where was it sold?
Walmart distribution centers in GA and AR
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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 Legacy Pharmaceutical Packaging
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|---|---|---|---|---|---|
| Drug | CLASS II | Sertraline Tablets, USP 100 mg recalled by Legacy PharmaceuticalSertraline Hydrochloride | Legacy Pharmaceutical Packaging | Manufacturing (CGMP) Deviations | AR, CA |
| Drug | CLASS II | Losartan Potassium Tablets, USP, 50 mg recalled by Legacy Pharmaceutical | Legacy Pharmaceutical Packaging | Nitrosamine Impurity | AZ, TN |
| Drug | CLASS II | Losartan Potassium Tablets, USP, 50 mg recalled by Legacy Pharmaceutical | Legacy Pharmaceutical Packaging | Nitrosamine Impurity | AZ, IN, TN |
| Drug | CLASS II | Losartan Potassium Tablets, USP, 50 mg recalled by Legacy Pharmaceutical | Legacy Pharmaceutical Packaging | Nitrosamine Impurity | 5 states |
| Drug | CLASS II | Losartan Potassium Tablets, USP, 25 mg recalled by Legacy Pharmaceutical | Legacy Pharmaceutical Packaging | Nitrosamine Impurity | 5 states |
Other Metformin recalls
All 61| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Metformin Hydrochloride Extended-Release Tablets 1000mg recalledMetformin Hydrochloride | 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 |