CLASS II ONGOING Drug recall · Reported 2 Apr 2025 · FDA Enforcement Report
Metformin Hydrochloride Extended- Release 500mg recalled
A-S Medication Solutions is recalling Metformin Hydrochloride Extended- Release 500mg, distributed nationwide in the US. The recall was initiated on 25 Feb 2025 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-0292-2025
- FDA event ID
- 96313
- Recalling firm
- A-S Medication Solutions, Libertyville, IL
- Manufacturer
- A-S Medication Solutions
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Feb 2025
- FDA classified
- 21 Mar 2025
- Reported
- 2 Apr 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Diabetes Medication
Timeline
| 25 Feb 2025 | Recall initiated by company | |
| 21 Mar 2025 | Classified by FDA | +24 days |
| 2 Apr 2025 | 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
Presence of Foreign Tablets/Capsules.
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 EXTENDED- RELEASE 500MG, 180 TABLETS, Packaged BY: A-S Medication Solutions, Libertyville, IL 60048 NDC 50090-1494-3.
Where it was distributed
Nationwide in U.S.
Questions about this recall
Why was it recalled?
Presence of Foreign Tablets/Capsules.
Which lots are affected?
Lot# 4260340; Exp.12/31/2025.
Where was it sold?
Nationwide in U.S.
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.
More recalls from A-S Medication Solutions
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Acetaminophen Extra Strength Tablets, 500 mg each recalledAcetaminophen | A-S Medication Solutions | Labeling Errors | Nationwide |
| Drug | CLASS III | Cetirizine hydrochloride recalled by A-S Medication SolutionsCetirizine | A-S Medication Solutions | Other | 4 states |
| Drug | CLASS I | Acetaminophen, Extra Strength, Aspirin Free, Mfr recalledAcetaminophen | A-S Medication Solutions | Packaging Defects | Nationwide |
| Drug | CLASS II | Valsartan Tablets, 160 MG bottle recalled by A-S Medication Solutions | A-S Medication Solutions | Potency & Assay | Nationwide |
| Drug | CLASS II | Valsartan and Hydrochlorothiazide Tablets recalled | A-S Medication Solutions | Potency & Assay | Nationwide |
Other Metformin recalls
All 61| 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 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 |
| Drug | CLASS II | Metformin 750 mg Extended Release recalled by RemedyRepack | RemedyRepack | Nitrosamine Impurity | PA |