Recall archive / FDA drug enforcement

Simvastatin Tablets, USP, 20 mg, Packaged as: a) 90-count bottle (NDC 68788-9869-9); b) 60-count bottle (NDC 68788-98... — FDA record D-0524-2023

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Mar 23, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Simvastatin Tablets, USP, 20 mg, Packaged as: a) 90-count bottle (NDC 68788-9869-9); b) 60-count bottle (NDC 68788-9869-6); c) 30-count bottle (NDC 68788-9869-3), Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703.
Reason: cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Classification: Class II
Recalling firm: Preferred Pharmaceuticals, Inc.
Quantity: a) 305 Bottles, b) 72 Bottles, c) 617 Bottles
Agency-reported status: Ongoing
Source record identifier: D-0524-2023

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	a) Lot: A0923R, Exp. Date: 2/28/2025, A1222K, B1822C, Exp. Date: 5/31/2024, C3022D, F2322V, Exp. Date: 6/30/2024, H1522H, Exp. Date: 8/31/2024, I1621O, Exp. Date: 1/31/2024, I2222G, J1822R, Exp. Date: 9/30/2024, L1621N, Exp. Date: 5/31/2024; b) Lot: F0822Q, Exp. Date: 6/30/2024, I0122J, Exp. Date: 8/31/2024, L0821C, Exp. Date: 5/31/2024; c) Lot: I1521P, Exp. Date: 1/31/2024, J1322R, Exp. Date: 9/30/2024, J1821H, Exp. Date: 2/29/2024.

Label field

Details supplied by the agency

Lot, code or applicability

a) Lot: A0923R, Exp. Date: 2/28/2025, A1222K, B1822C, Exp. Date: 5/31/2024, C3022D, F2322V, Exp. Date: 6/30/2024, H1522H, Exp. Date: 8/31/2024, I1621O, Exp. Date: 1/31/2024, I2222G, J1822R, Exp. Date: 9/30/2024, L1621N, Exp. Date: 5/31/2024; b) Lot: F0822Q, Exp. Date: 6/30/2024, I0122J, Exp. Date: 8/31/2024, L0821C, Exp. Date: 5/31/2024; c) Lot: I1521P, Exp. Date: 1/31/2024, J1322R, Exp. Date: 9/30/2024, J1821H, Exp. Date: 2/29/2024.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

USA Nationwide

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Apr 12, 2023
Recall initiation date: Mar 23, 2023
Center classification date: Apr 6, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.