CLASS II Drug recall · Reported 12 Apr 2023 · FDA Enforcement Report
Glimepiride 2 mg tablets, packaged in a) 30-count bottles recalled
RemedyRepack is recalling Glimepiride 2 mg tablets, packaged in a) 30-count bottles (, distributed nationwide in the US. The recall was initiated on 20 Mar 2023 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-0493-2023
- FDA event ID
- 91980
- Recalling firm
- RemedyRepack, Indiana, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Mar 2023
- FDA classified
- 31 Mar 2023
- Reported
- 12 Apr 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Diabetes Medication
Timeline
| 20 Mar 2023 | Recall initiated by company | |
| 31 Mar 2023 | Classified by FDA | +11 days |
| 12 Apr 2023 | 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
cGMP Deviations
Product as listed by the FDA
Glimepiride 2 mg tablets, packaged in a) 30-count bottles (NDC 70518-0405-03), b) 90-count bottles (NDC 70518-0405-00) and c)180-count bottles (NDC 70518-0405-02), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701
Where it was distributed
RemedyRepack distributed product to consignees nationwide within the United States
Questions about this recall
Is Glimepiride 2 mg tablets, packaged in a) 30-count bottles ( recalled?
Yes. RemedyRepack recalled Glimepiride 2 mg tablets, packaged in a) 30-count bottles ( on 20 Mar 2023. The recall is Class II and its status is Terminated. Recall number D-0493-2023.
Why was it recalled?
cGMP Deviations
Which lots are affected?
Lot #: a) J0674153-010923, Exp. Date 01/31/2024; J0649447-092822, Exp. Date 10/31/2023; J0644887-090722, Exp. Date 09/30/2023; J0627309-062222, Exp. Date 06/30/2023; J0622569-060222, Exp. Date 06/30/2023. b) B1646259-041222, Exp. Date 04/30/2023; B2032846-122722, Exp. Date 01/31/2025 B2018675-121722, Exp. Date 05/31/2025; B1708230-060122, B1709748-060122, Exp. Date 06/30/2023; B1692572-051822, Exp. Date 05/31/2023; B1803110-081122, Exp. Date 12/31/2024. c) B1820672-082422, B1814883-082022, Exp. Date 09/30/2024.
Where was it sold?
RemedyRepack distributed product to consignees nationwide within the United States
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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