Glimepiride Tablets Recalled Due to Manufacturing Process Deviations
Preferred Pharmaceuticals recalls Glimepiride Tablets, 2 mg, 90-count bottles due to manufacturing process deviations discovered during FDA inspection. No illnesses have been reported.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II classification indicates potential for adverse health consequences, but no illnesses, injuries, or hospitalizations are reported in the source. The hazard is manufacturing process compliance violations (cGMP deviations) without specific product defects described.
Plain-English summary
Preferred Pharmaceuticals, Inc. is recalling Glimepiride Tablets, USP, 2 mg, in 90-count bottles manufactured by Accord Healthcare, Inc., Durham, NC. The affected lots are: D0122K (expiration date 6/30/2024), I1422N (expiration date 9/30/2024), and I2721B (expiration date 1/31/2024), with NDC 68788-8095-9. A total of 17 bottles were distributed nationwide.
The recall was issued because current Good Manufacturing Practice (cGMP) deviations were identified at the manufacturing facility during an FDA inspection. These deviations relate to controls used in the manufacturing process.
Patients currently taking Glimepiride should contact their healthcare provider or pharmacist regarding this recall. Do not stop taking the medication without speaking to a healthcare professional first. Return any recalled bottles to the pharmacy where they were dispensed or contact Preferred Pharmaceuticals for further guidance.
Adverse events or product quality concerns should be reported to the FDA's MedWatch program.
The recalled product
- Product
- Glimepiride Tablets, USP, 2 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8095-9
- Manufacturer
- Preferred Pharmaceuticals, Inc.
- Category
- Drug — Antidiabetic medication
- Hazard
- manufacturing-deviation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot: D0122K
- Exp. Date: 6/30/2024
- Lot: I1422N
- Exp. Date: 9/30/2024
- Lot: I2721B
- Exp. Date: 1/31/2024.
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- LowPrimidone Tablets Recalled Due to Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27