Preferred Pharmaceuticals Glimepiride Tablets Recall (Class II)

Why it was recalled

cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Product description

Glimepiride Tablets USP, 4 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8066-9

Lot numbers, UPCs & expiration codes

Lot: H1221Z, I0121J, J0622X, Exp 10/31/2023.

Where it was sold

USA Nationwide

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0527-2023
Classification: Class II
Status: Ongoing
Recall initiated: Mar 23, 2023
FDA report date: Apr 12, 2023
Quantity: 15 Bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Preferred Pharmaceuticals, Inc.

Original FDA data

Every field from FDA enforcement report D-0527-2023, exactly as published.

Show all FDA fields

City: Anaheim
State: CA
Status: Ongoing
Country: United States
Event ID: 91952
Address: 1250 N Lakeview Ave Ste O
Code information: Lot: H1221Z, I0121J, J0622X, Exp 10/31/2023.
Postal code: 92807-1801
Report date: Apr 12, 2023
Product type: Drugs
Recall number: D-0527-2023
Classification: Class II
Recalling firm: Preferred Pharmaceuticals, Inc.
Product quantity: 15 Bottles
Reason for recall: cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Voluntary / mandated: Voluntary: Firm initiated
Product description: Glimepiride Tablets USP, 4 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8066-9
Distribution pattern: USA Nationwide
Recall initiation date: Mar 23, 2023
Initial firm notification: Letter
Center classification date: Apr 6, 2023

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0527-2023, published Apr 12, 2023. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

Preferred Pharmaceuticals Glimepiride Tablets Recall

Summary