Medications & Supplements/Prescription Drugs

Preferred Pharmaceuticals Drugs Recalled for Manufacturing Deviations

Agency Publication Date: April 6, 2023

Summary

Preferred Pharmaceuticals, Inc. is recalling 1,956 bottles of various prescription medications, including Lipitor (atorvastatin), Plavix (clopidogrel), and Zocor (simvastatin). This recall was initiated due to manufacturing failures (cGMP deviations) identified during an FDA inspection of Accord Healthcare, the original manufacturing firm. Affected products include various strengths of medications for cholesterol, blood pressure, prostate health, asthma, and diabetes.

Risk

The medications may have been manufactured under conditions that do not meet federal quality standards, which can compromise the safety, identity, strength, or purity of the drugs. While no specific injuries have been reported, drugs made with manufacturing deviations pose a potential risk to patients' health.

What You Should Do

This recall affects various strengths of Atorvastatin, Clopidogrel, Doxazosin, Finasteride, Glimepiride, Montelukast, Rosuvastatin, Pravastatin, Simvastatin, and Tadalafil tablets sold under the Preferred Pharmaceuticals label.
Identify if your medication is affected by checking the drug name, bottle size, and NDC number on your prescription label. See the Affected Products section below for the full list of affected codes.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Preferred Pharmaceuticals, Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions or to report a problem.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Atorvastatin Calcium Tablets (90-count bottle)

Variants: 10 mg, Rx only

Lot Numbers:

A0523D (Exp 5/31/2024)

F14220 (Exp 7/31/2023)

J0622Q (Exp 1/31/2024)

NDC:

68788-7630-9

Recall #: D-0511-2023

Product: Atorvastatin Calcium Tablets (90-count and 30-count bottles)

Variants: 20 mg, Rx only

Lot Numbers:

B1522B (Exp 4/30/2023)

C0222H (Exp 5/31/2023)

C0322B (Exp 5/31/2023)

E1022H (Exp 6/30/2023)

F13220 (Exp 6/30/2023)

H2222P (Exp 6/30/2023)

I1422V (Exp 12/31/2023)

K01220 (Exp 12/31/2023)

L2722H (Exp 3/31/2024)

H1122G (Exp 6/30/2023)

12322Q (Exp 6/30/2023)

J1222U (Exp 12/31/2023)

NDC:

68788-7631-9

68788-7631-3

Recall #: D-0512-2023

Product: Clopidogrel Tablets (90-count bottle)

Variants: 75 mg, Rx only

Lot Numbers:

E0922W (Exp 10/31/2023)

G1222E (Exp 10/31/2023)

I0922W (Exp 10/31/2023)

K3022W (Exp 10/31/2023)

NDC:

68788-8190-9

Recall #: D-0513-2023

Product: Doxazosin Tablets (100-count bottle)

Variants: 2 mg, Rx only

Lot Numbers:

H3122K (Exp 5/31/2024)

NDC:

68788-7328-1

Recall #: D-0514-2023

Product: Doxazosin Tablets (100-count bottle)

Variants: 4 mg, Rx only

Lot Numbers:

L1522V (Exp 4/30/2025)

NDC:

68788-7149-1

Recall #: D-0515-2023

Product: Finasteride Tablets (30-count and 90-count bottles)

Variants: 5 mg, Rx only

Lot Numbers:

A1321V (Exp 8/31/2023)

D0221J (Exp 8/31/2023)

A1322J (Exp 5/31/2024)

F0221Q (Exp 10/31/2023)

I0121E (Exp 10/31/2023)

I1021R (Exp 10/31/2023)

J1122D (Exp 10/31/2023)

B0422J (Exp 5/31/2024)

C1721K (Exp 8/31/2023)

K1022Q (Exp 11/30/2024)

NDC:

68788-6976-3

68788-6976-9

Recall #: D-0516-2023

Product: Glimepiride Tablets (90-count bottle)

Variants: 2 mg, Rx only

Lot Numbers:

D0122K (Exp 6/30/2024)

I1422N (Exp 9/30/2024)

I2721B (Exp 1/31/2024)

NDC:

68788-8095-9

Recall #: D-0517-2023

Product: Montelukast Sodium Tablets (30, 60, and 90-count bottles)

Variants: 10 mg, Rx only

Lot Numbers:

F3021D (Exp 12/31/2023)

L0722T (Exp 5/31/2025)

F1021I (Exp 12/31/2023)

H1721R (Exp 12/31/2023)

L0722E (Exp 5/31/2025)

NDC:

68788-9438-3

68788-9438-6

68788-9438-9

Recall #: D-0518-2023

Product: Rosuvastatin Tablets (30-count and 90-count bottles)

Variants: 10 mg, Rx only

Lot Numbers:

F2022N (Exp 2/29/2024)

F0322I (Exp 8/31/2023)

J1322H (Exp 2/29/2024)

K0222N (Exp 6/30/2024)

L2322D (Exp 7/31/2025)

L2822J (Exp 7/31/2025)

NDC:

68788-7086-3

68788-7086-9

Recall #: D-0519-2023

Product: Rosuvastatin Tablets (30-count bottle)

Variants: 5 mg, Rx only

Lot Numbers:

A1723C (Exp 8/31/2025)

A1922B (Exp 6/30/2024)

D0622M (Exp 7/31/2024)

F2922I (Exp 7/31/2024)

G3021L (Exp 1/31/2024)

H2622P (Exp 10/31/2024)

J0722C (Exp 10/31/2024)

NDC:

68788-7971-3

Recall #: D-0520-2023

Product: Pravastatin Sodium Tablets (90-count bottle)

Variants: 20 mg, Rx only

Lot Numbers:

F1021I (Exp 4/30/2024)

H3122J (Exp 4/30/2024)

NDC:

68788-8215-9

Recall #: D-0521-2023

Product: Simvastatin Tablets (90-count bottle)

Variants: 10 mg, Rx only

Lot Numbers:

C2222P (Exp 9/30/2023)

D1522L (Exp 9/30/2023)

E3122D (Exp 9/30/2023)

G2522J (Exp 9/30/2023)

J1222R (Exp 10/31/2023)

NDC:

68788-9747-9

Recall #: D-0522-2023

Product: Simvastatin Tablets (90-count bottle)

Variants: 80 mg, Rx only

Lot Numbers:

B0222S (Exp 2/29/2024)

F1121B (Exp 11/30/2023)

G2721L (Exp 11/30/2023)

NDC:

68788-9429-9

Recall #: D-0523-2023

Product: Simvastatin Tablets (90, 60, and 30-count bottles)

Variants: 20 mg, Rx only

Lot Numbers:

A0923R (Exp 2/28/2025)

A1222K (Exp 5/31/2024)

B1822C (Exp 5/31/2024)

C3022D (Exp 6/30/2024)

F2322V (Exp 6/30/2024)

H1522H (Exp 8/31/2024)

I1621O (Exp 1/31/2024)

I2222G (Exp 9/30/2024)

J1822R (Exp 9/30/2024)

L1621N (Exp 5/31/2024)

F0822Q (Exp 6/30/2024)

I0122J (Exp 8/31/2024)

L0821C (Exp 5/31/2024)

I1521P (Exp 1/31/2024)

J1322R (Exp 9/30/2024)

J1821H (Exp 2/29/2024)

NDC:

68788-9869-9

68788-9869-6

68788-9869-3

Recall #: D-0524-2023

Product: Simvastatin Tablets (90, 60, and 30-count bottles)

Variants: 40 mg, Rx only

Lot Numbers:

B0922G (Exp 5/31/2023)

F0322G (Exp 7/25/2024)

H2622M (Exp 8/31/2024)

J1422B (Exp 10/31/2024)

K0722G (Exp 10/31/2024)

L1922A (Exp 2/28/2025)

F2922S (Exp 8/31/2023)

H0322G (Exp 7/31/2023)

A1322I (Exp 3/31/2023)

H1122C (Exp 8/31/2024)

NDC:

68788-9868-9

68788-9868-6

68788-9868-3

Recall #: D-0525-2023

Product: Tadalafil Tablets (7-count bottle)

Variants: 20 mg, Rx only

Lot Numbers:

C0822E (Exp 1/31/2024)

F1121B (Exp 1/31/2024)

G2721L (Exp 1/31/2024)

NDC:

68788-8153-7

Recall #: D-0526-2023

Product: Glimepiride Tablets (90-count bottle)

Variants: 4 mg, Rx only

Lot Numbers:

H1221Z (Exp 10/31/2023)

I0121J (Exp 10/31/2023)

J0622X (Exp 10/31/2023)

NDC:

68788-8066-9

Recall #: D-0527-2023

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91952

Status: Active

Manufacturer: Preferred Pharmaceuticals, Inc.

Sold By: Pharmacies; Healthcare Providers

Manufactured In: United States

Units Affected: 17 products (158 Bottles; a) 375 Bottles b) 323 Bottles; 72 Bottles; 3 Bottles; 4 Bottles; a) 135 Bottles, b) 24 Bottles; 17 Bottles; a) 266 Bottles, b) not reported, c) 216 Bottles; a) 59 Bottles, b) 77 Bottles; 264 Bottles; 24 Bottles; 82 Bottles of 90 Tablets; 57 Bottles; a) 305 Bottles, b) 72 Bottles, c) 617 Bottles; a) 88 Bottles, b) 3 Bottles, c) 175 Bottles; 32 Bottles; 15 Bottles)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

This recall affects various strengths of Atorvastatin, Clopidogrel, Doxazosin, Finasteride, Glimepiride, Montelukast, Rosuvastatin, Pravastatin, Simvastatin, and Tadalafil tablets sold under the Preferred Pharmaceuticals label.

Identify if your medication is affected by checking the drug name, bottle size, and NDC number on your prescription label. See the Affected Products section below for the full list of affected codes.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Preferred Pharmaceuticals, Inc. for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions or to report a problem.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Atorvastatin Calcium Tablets (90-count bottle)

Variants: 10 mg, Rx only

Lot Numbers:

A0523D (Exp 5/31/2024)

F14220 (Exp 7/31/2023)

J0622Q (Exp 1/31/2024)

NDC:

68788-7630-9

Recall #: D-0511-2023

Product: Atorvastatin Calcium Tablets (90-count and 30-count bottles)

Variants: 20 mg, Rx only

Lot Numbers:

B1522B (Exp 4/30/2023)

C0222H (Exp 5/31/2023)

C0322B (Exp 5/31/2023)

E1022H (Exp 6/30/2023)

F13220 (Exp 6/30/2023)

H2222P (Exp 6/30/2023)

I1422V (Exp 12/31/2023)

K01220 (Exp 12/31/2023)

L2722H (Exp 3/31/2024)

H1122G (Exp 6/30/2023)

12322Q (Exp 6/30/2023)

J1222U (Exp 12/31/2023)

NDC:

68788-7631-9

68788-7631-3

Recall #: D-0512-2023

Product: Clopidogrel Tablets (90-count bottle)

Variants: 75 mg, Rx only

Lot Numbers:

E0922W (Exp 10/31/2023)

G1222E (Exp 10/31/2023)

I0922W (Exp 10/31/2023)

K3022W (Exp 10/31/2023)

NDC:

68788-8190-9

Recall #: D-0513-2023

Product: Doxazosin Tablets (100-count bottle)

Variants: 2 mg, Rx only

Lot Numbers:

H3122K (Exp 5/31/2024)

NDC:

68788-7328-1

Recall #: D-0514-2023

Product: Doxazosin Tablets (100-count bottle)

Variants: 4 mg, Rx only

Lot Numbers:

L1522V (Exp 4/30/2025)

NDC:

68788-7149-1

Recall #: D-0515-2023

Product: Finasteride Tablets (30-count and 90-count bottles)

Variants: 5 mg, Rx only

Lot Numbers:

A1321V (Exp 8/31/2023)

D0221J (Exp 8/31/2023)

A1322J (Exp 5/31/2024)

F0221Q (Exp 10/31/2023)

I0121E (Exp 10/31/2023)

I1021R (Exp 10/31/2023)

J1122D (Exp 10/31/2023)

B0422J (Exp 5/31/2024)

C1721K (Exp 8/31/2023)

K1022Q (Exp 11/30/2024)

NDC:

68788-6976-3

68788-6976-9

Recall #: D-0516-2023

Product: Glimepiride Tablets (90-count bottle)

Variants: 2 mg, Rx only

Lot Numbers:

D0122K (Exp 6/30/2024)

I1422N (Exp 9/30/2024)

I2721B (Exp 1/31/2024)

NDC:

68788-8095-9

Recall #: D-0517-2023

Product: Montelukast Sodium Tablets (30, 60, and 90-count bottles)

Variants: 10 mg, Rx only

Lot Numbers:

F3021D (Exp 12/31/2023)

L0722T (Exp 5/31/2025)

F1021I (Exp 12/31/2023)

H1721R (Exp 12/31/2023)

L0722E (Exp 5/31/2025)

NDC:

68788-9438-3

68788-9438-6

68788-9438-9

Recall #: D-0518-2023

Product: Rosuvastatin Tablets (30-count and 90-count bottles)

Variants: 10 mg, Rx only

Lot Numbers:

F2022N (Exp 2/29/2024)

F0322I (Exp 8/31/2023)

J1322H (Exp 2/29/2024)

K0222N (Exp 6/30/2024)

L2322D (Exp 7/31/2025)

L2822J (Exp 7/31/2025)

NDC:

68788-7086-3

68788-7086-9

Recall #: D-0519-2023

Product: Rosuvastatin Tablets (30-count bottle)

Variants: 5 mg, Rx only

Lot Numbers:

A1723C (Exp 8/31/2025)

A1922B (Exp 6/30/2024)

D0622M (Exp 7/31/2024)

F2922I (Exp 7/31/2024)

G3021L (Exp 1/31/2024)

H2622P (Exp 10/31/2024)

J0722C (Exp 10/31/2024)

NDC:

68788-7971-3

Recall #: D-0520-2023

Product: Pravastatin Sodium Tablets (90-count bottle)

Variants: 20 mg, Rx only

Lot Numbers:

F1021I (Exp 4/30/2024)

H3122J (Exp 4/30/2024)

NDC:

68788-8215-9

Recall #: D-0521-2023

Product: Simvastatin Tablets (90-count bottle)

Variants: 10 mg, Rx only

Lot Numbers:

C2222P (Exp 9/30/2023)

D1522L (Exp 9/30/2023)

E3122D (Exp 9/30/2023)

G2522J (Exp 9/30/2023)

J1222R (Exp 10/31/2023)

NDC:

68788-9747-9

Recall #: D-0522-2023

Product: Simvastatin Tablets (90-count bottle)

Variants: 80 mg, Rx only

Lot Numbers:

B0222S (Exp 2/29/2024)

F1121B (Exp 11/30/2023)

G2721L (Exp 11/30/2023)

NDC:

68788-9429-9

Recall #: D-0523-2023

Product: Simvastatin Tablets (90, 60, and 30-count bottles)

Variants: 20 mg, Rx only

Lot Numbers:

A0923R (Exp 2/28/2025)

A1222K (Exp 5/31/2024)

B1822C (Exp 5/31/2024)

C3022D (Exp 6/30/2024)

F2322V (Exp 6/30/2024)

H1522H (Exp 8/31/2024)

I1621O (Exp 1/31/2024)

I2222G (Exp 9/30/2024)

J1822R (Exp 9/30/2024)

L1621N (Exp 5/31/2024)

F0822Q (Exp 6/30/2024)

I0122J (Exp 8/31/2024)

L0821C (Exp 5/31/2024)

I1521P (Exp 1/31/2024)

J1322R (Exp 9/30/2024)

J1821H (Exp 2/29/2024)

NDC:

68788-9869-9

68788-9869-6

68788-9869-3

Recall #: D-0524-2023

Product: Simvastatin Tablets (90, 60, and 30-count bottles)

Variants: 40 mg, Rx only

Lot Numbers:

B0922G (Exp 5/31/2023)

F0322G (Exp 7/25/2024)

H2622M (Exp 8/31/2024)

J1422B (Exp 10/31/2024)

K0722G (Exp 10/31/2024)

L1922A (Exp 2/28/2025)

F2922S (Exp 8/31/2023)

H0322G (Exp 7/31/2023)

A1322I (Exp 3/31/2023)

H1122C (Exp 8/31/2024)

NDC:

68788-9868-9

68788-9868-6

68788-9868-3

Recall #: D-0525-2023

Product: Tadalafil Tablets (7-count bottle)

Variants: 20 mg, Rx only

Lot Numbers:

C0822E (Exp 1/31/2024)

F1121B (Exp 1/31/2024)

G2721L (Exp 1/31/2024)

NDC:

68788-8153-7

Recall #: D-0526-2023

Product: Glimepiride Tablets (90-count bottle)

Variants: 4 mg, Rx only

Lot Numbers:

H1221Z (Exp 10/31/2023)

I0121J (Exp 10/31/2023)

J0622X (Exp 10/31/2023)

NDC:

68788-8066-9

Recall #: D-0527-2023

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91952

Status: Active

Manufacturer: Preferred Pharmaceuticals, Inc.

Sold By: Pharmacies; Healthcare Providers

Manufactured In: United States

Distributed To: Nationwide