Medications & Supplements/Over-the-Counter

PD-Rx Pharmaceuticals, Inc.: Ibuprofen 200 mg Tablets Recalled for Manufacturing Quality Deviations

Agency Publication Date: February 1, 2018

Summary

PD-Rx Pharmaceuticals, Inc. is recalling 7,174 bottles of Ibuprofen 200 mg tablets because of deviations from Current Good Manufacturing Practice (CGMP) requirements. The recall affects several package sizes, including 24, 30, 50, and 60-count bottles distributed nationwide. These manufacturing issues mean the safety, identity, and quality of the medication cannot be guaranteed. Consumers who have these products should stop using them and contact their healthcare provider or pharmacist for guidance on alternative treatments and a refund.

Risk

Manufacturing deviations can lead to products that do not meet quality standards, potentially resulting in incorrect dosage, contamination, or reduced effectiveness of the medication. No specific injuries or incidents have been reported in this notice.

What You Should Do

Check your Ibuprofen 200 mg tablet bottles for the following NDC numbers: 55289-673-24 (24 tablets), 55289-673-30 (30 tablets), 55289-673-50 (50 tablets), or 55289-673-60 (60 tablets).
Verify if your bottle matches one of the following lot numbers and expiration dates: K16E92 (Exp. 5/31/18), B17A87 (Exp. 5/31/18), E17A51 (Exp. 5/31/18), L16B59 (Exp. 1/31/18), K16E01 (Exp. 5/31/18), A17F21 (Exp. 5/31/18), B17D71 (Exp. 5/31/18), D17E92 (Exp. 5/31/18), J16D13 (Exp. 1/31/18), A17D63 (Exp. 5/31/18), E17A18 (Exp. 5/31/18), F17B87 (Exp. 5/31/18), or C17C58 (Exp. 5/31/18).
Contact your healthcare provider or pharmacist immediately to discuss using an alternative ibuprofen product and to report any adverse health effects.
Return any unused portions of the recalled medication to the place of purchase for a refund or contact PD-Rx Pharmaceuticals, Inc. at their Oklahoma City office for further instructions.
For additional questions or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

Full Refund

Healthcare provider consultation and pharmacy refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Ibuprofen 200 mg tablets (24 tablets)

Model:

NDC 55289-673-24

Recall #: D-0341-2018

Lot Numbers:

K16E92 (Exp. 5/31/18)

B17A87 (Exp. 5/31/18)

E17A51 (Exp. 5/31/18)

L16B59 (Exp. 1/31/18)

K16E01 (Exp. 5/31/18)

A17F21 (Exp. 5/31/18)

B17D71 (Exp. 5/31/18)

D17E92 (Exp. 5/31/18)

J16D13 (Exp. 1/31/18)

A17D63 (Exp. 5/31/18)

E17A18 (Exp. 5/31/18)

F17B87 (Exp. 5/31/18)

C17C58 (Exp. 5/31/18)

Date Ranges: 5/31/18, 1/31/18

Product: Ibuprofen 200 mg tablets (30 tablets)

Model:

NDC 55289-673-30

Recall #: D-0341-2018

Lot Numbers:

K16E92 (Exp. 5/31/18)

B17A87 (Exp. 5/31/18)

E17A51 (Exp. 5/31/18)

L16B59 (Exp. 1/31/18)

K16E01 (Exp. 5/31/18)

A17F21 (Exp. 5/31/18)

B17D71 (Exp. 5/31/18)

D17E92 (Exp. 5/31/18)

J16D13 (Exp. 1/31/18)

A17D63 (Exp. 5/31/18)

E17A18 (Exp. 5/31/18)

F17B87 (Exp. 5/31/18)

C17C58 (Exp. 5/31/18)

Date Ranges: 5/31/18, 1/31/18

Product: Ibuprofen 200 mg tablets (50 tablets)

Model:

NDC 55289-673-50

Recall #: D-0341-2018

Lot Numbers:

K16E92 (Exp. 5/31/18)

B17A87 (Exp. 5/31/18)

E17A51 (Exp. 5/31/18)

L16B59 (Exp. 1/31/18)

K16E01 (Exp. 5/31/18)

A17F21 (Exp. 5/31/18)

B17D71 (Exp. 5/31/18)

D17E92 (Exp. 5/31/18)

J16D13 (Exp. 1/31/18)

A17D63 (Exp. 5/31/18)

E17A18 (Exp. 5/31/18)

F17B87 (Exp. 5/31/18)

C17C58 (Exp. 5/31/18)

Date Ranges: 5/31/18, 1/31/18

Product: Ibuprofen 200 mg tablets (60 tablets)

Model:

NDC 55289-673-60

Recall #: D-0341-2018

Lot Numbers:

K16E92 (Exp. 5/31/18)

B17A87 (Exp. 5/31/18)

E17A51 (Exp. 5/31/18)

L16B59 (Exp. 1/31/18)

K16E01 (Exp. 5/31/18)

A17F21 (Exp. 5/31/18)

B17D71 (Exp. 5/31/18)

D17E92 (Exp. 5/31/18)

J16D13 (Exp. 1/31/18)

A17D63 (Exp. 5/31/18)

E17A18 (Exp. 5/31/18)

F17B87 (Exp. 5/31/18)

C17C58 (Exp. 5/31/18)

Date Ranges: 5/31/18, 1/31/18

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 79023

Status: Resolved

Manufacturer: PD-Rx Pharmaceuticals, Inc.

Manufactured In: United States

Units Affected: 7174 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

What You Should Do

Check your Ibuprofen 200 mg tablet bottles for the following NDC numbers: 55289-673-24 (24 tablets), 55289-673-30 (30 tablets), 55289-673-50 (50 tablets), or 55289-673-60 (60 tablets).

Verify if your bottle matches one of the following lot numbers and expiration dates: K16E92 (Exp. 5/31/18), B17A87 (Exp. 5/31/18), E17A51 (Exp. 5/31/18), L16B59 (Exp. 1/31/18), K16E01 (Exp. 5/31/18), A17F21 (Exp. 5/31/18), B17D71 (Exp. 5/31/18), D17E92 (Exp. 5/31/18), J16D13 (Exp. 1/31/18), A17D63 (Exp. 5/31/18), E17A18 (Exp. 5/31/18), F17B87 (Exp. 5/31/18), or C17C58 (Exp. 5/31/18).

Contact your healthcare provider or pharmacist immediately to discuss using an alternative ibuprofen product and to report any adverse health effects.

Return any unused portions of the recalled medication to the place of purchase for a refund or contact PD-Rx Pharmaceuticals, Inc. at their Oklahoma City office for further instructions.

For additional questions or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Affected Products

Product: Ibuprofen 200 mg tablets (24 tablets)

Model:

NDC 55289-673-24

Recall #: D-0341-2018

Lot Numbers:

K16E92 (Exp. 5/31/18)

B17A87 (Exp. 5/31/18)

E17A51 (Exp. 5/31/18)

L16B59 (Exp. 1/31/18)

K16E01 (Exp. 5/31/18)

A17F21 (Exp. 5/31/18)

B17D71 (Exp. 5/31/18)

D17E92 (Exp. 5/31/18)

J16D13 (Exp. 1/31/18)

A17D63 (Exp. 5/31/18)

E17A18 (Exp. 5/31/18)

F17B87 (Exp. 5/31/18)

C17C58 (Exp. 5/31/18)

Date Ranges: 5/31/18, 1/31/18

Product: Ibuprofen 200 mg tablets (30 tablets)

Model:

NDC 55289-673-30

Recall #: D-0341-2018

Lot Numbers:

K16E92 (Exp. 5/31/18)

B17A87 (Exp. 5/31/18)

E17A51 (Exp. 5/31/18)

L16B59 (Exp. 1/31/18)

K16E01 (Exp. 5/31/18)

A17F21 (Exp. 5/31/18)

B17D71 (Exp. 5/31/18)

D17E92 (Exp. 5/31/18)

J16D13 (Exp. 1/31/18)

A17D63 (Exp. 5/31/18)

E17A18 (Exp. 5/31/18)

F17B87 (Exp. 5/31/18)

C17C58 (Exp. 5/31/18)

Date Ranges: 5/31/18, 1/31/18

Product: Ibuprofen 200 mg tablets (50 tablets)

Model:

NDC 55289-673-50

Recall #: D-0341-2018

Lot Numbers:

K16E92 (Exp. 5/31/18)

B17A87 (Exp. 5/31/18)

E17A51 (Exp. 5/31/18)

L16B59 (Exp. 1/31/18)

K16E01 (Exp. 5/31/18)

A17F21 (Exp. 5/31/18)

B17D71 (Exp. 5/31/18)

D17E92 (Exp. 5/31/18)

J16D13 (Exp. 1/31/18)

A17D63 (Exp. 5/31/18)

E17A18 (Exp. 5/31/18)

F17B87 (Exp. 5/31/18)

C17C58 (Exp. 5/31/18)

Date Ranges: 5/31/18, 1/31/18

Product: Ibuprofen 200 mg tablets (60 tablets)

Model:

NDC 55289-673-60

Recall #: D-0341-2018

Lot Numbers:

K16E92 (Exp. 5/31/18)

B17A87 (Exp. 5/31/18)

E17A51 (Exp. 5/31/18)

L16B59 (Exp. 1/31/18)

K16E01 (Exp. 5/31/18)

A17F21 (Exp. 5/31/18)

B17D71 (Exp. 5/31/18)

D17E92 (Exp. 5/31/18)

J16D13 (Exp. 1/31/18)

A17D63 (Exp. 5/31/18)

E17A18 (Exp. 5/31/18)

F17B87 (Exp. 5/31/18)

C17C58 (Exp. 5/31/18)

Date Ranges: 5/31/18, 1/31/18