CLASS III ONGOING Drug recall · Reported 14 Feb 2024 · FDA Enforcement Report
Glimepiride Tablets, USP 1mg recalled by Dr. Reddy's Laboratories
Dr. Reddy's Laboratories is recalling Glimepiride Tablets, USP 1mg, distributed nationwide in the US. The recall was initiated on 18 Jan 2024 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-0312-2024
- FDA event ID
- 93833
- Recalling firm
- Dr. Reddy's Laboratories, Princeton, NJ
- Brand
- Glimepiride
- Manufacturer
- Dr. Reddy's Laboratories Limited
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 18 Jan 2024
- FDA classified
- 6 Feb 2024
- Reported
- 14 Feb 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Diabetes Medication
Timeline
| 18 Jan 2024 | Recall initiated by company | |
| 6 Feb 2024 | Classified by FDA | +19 days |
| 14 Feb 2024 | 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
Misprint on tablet
Product as listed by the FDA
Glimepiride Tablets, USP 1mg, 100-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409 INDIA, NDC: 55111-320-01
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Misprint on tablet
Which lots are affected?
Lot: T2303622; Exp. 06/2026 Lot: T2303626; Exp. 06/2026 Lot: T2303627; Exp. 06/2026 Lot: T2303628; Exp. 06/2026 Lot: T2303629; Exp. 06/2026
Where was it sold?
Nationwide
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.
Other products in this recall event
1 other product · FDA event 93833This product is part of a recall event; the main page for the event is Glimepiride Tablets, USP 1mg recalled by Dr. Reddy's Laboratories.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Glimepiride Tablets, USP 1mg recalled by Dr. Reddy's LaboratoriesGlimepiride | Dr. Reddy's Laboratories | Other | Nationwide |
More recalls from Dr. Reddy's Laboratories
All 165| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Varenicline Tablets, 1mg recalled by Dr. Reddy's LaboratoriesVarenicline Tartrate | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Succinylcholine Chloride Injection, USP, 200 mg/ (20 mg/mL) recalledSuccinylcholine | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Omeprazole Delayed-release Capsules, USP, 20mg recalledOmeprazole | Dr. Reddy's Laboratories | Other | Nationwide |
| Drug | CLASS I | Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg recalledLevetiracetam | Dr. Reddy's Laboratories | Labeling Errors | Nationwide |
| Drug | CLASS III | Javygtor (sapropterin dihydrochloride) Tablets 100mg recalledJavygtor | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
Other Glimepiride recalls
All 19| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Glimepiride Tablets, USP 1mg recalled by Dr. Reddy's LaboratoriesGlimepiride | Dr. Reddy's Laboratories | Other | Nationwide |
| Drug | CLASS II | Glimepiride Tablets, USP, 1 mg, RX, Packaged as a) recalled | Amerisource Health Services | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Glimepiride Tablets, USP, 2 mg, RX, Packaged as a ) recalled | Amerisource Health Services | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Glimepiride Tablets, USP, 4 mg, RX, Packaged as a) recalled | Amerisource Health Services | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Glimepiride USP, 4 mg-bottles recalled by PD-Rx Pharmaceuticals | PD-Rx Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |