Medications & Supplements/Prescription Drugs

PD-Rx Pharmaceuticals, Inc.: Doxycycline Hyclate 100 mg Tablets Recalled for Failed Dissolution Results

Agency Publication Date: August 24, 2018

Summary

PD-Rx Pharmaceuticals, Inc. is recalling approximately 6,641 bottles of Doxycycline Hyclate USP Tablets (100 mg), an antibiotic medication. The recall was initiated because the tablets failed dissolution testing, which means the medication may not dissolve properly in the body as intended. These products were repackaged from West-Ward Pharmaceutical Corp. lots and distributed nationwide in various bottle sizes ranging from 2-count to 400-count containers.

Risk

When a medication fails dissolution specifications, it may not be absorbed correctly by the body, potentially leading to a lower-than-intended dose. This can reduce the effectiveness of the antibiotic in treating bacterial infections.

What You Should Do

Identify if you have the affected Doxycycline Hyclate USP Tablets (100 mg) by checking the NDC numbers and lot codes on your prescription bottle. Affected NDC numbers include: 55289-866-02, 55289-866-06, 55289-866-07, 55289-866-10, 55289-866-14, 55289-866-20, 55289-866-28, 55289-866-30, 55289-866-98, 55289-866-87, and 55289-866-74.
Check your bottle for the following lot numbers and expiration dates: D17D29, L17C73, F18E73, H17D70, K17F66, G18F26, C18G26, F18E36, F18A85, K17B44, K17E29, L17D93 (all Exp. 1/31/19); E17B88 (Exp. 5/31/19); H17A52, H17D67 (Exp. 7/31/19); E17B01, E17E83 (Exp. 5/31/19); F17C99 (Exp. 6/30/19); G17C08, G17E18, H17B01, H17B66, H17F67, I17A56, E17E27 (Exp. 1/31/19); I17A33, G17D62, E17B35, E17D90 (Exp. 5/31/19); F17C13 (Exp. 6/30/19); G17B25, H17C58, G17D59, I17A69, G17D58, and G17D56 (all Exp. 7/31/19).
If you find you have an affected lot, contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement prescription.
Return any unused tablets to the pharmacy where you purchased them for a refund and contact PD-Rx Pharmaceuticals at 1-800-299-7379 for further return instructions.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Contact healthcare provider or pharmacist and return for refund.

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

Affected Products

Product: Doxycycline Hyclate USP Tablets, 100 mg (2-count bottle)

Model:

NDC 55289-866-02

Lot Numbers:

D17D29 (Exp. 1/31/19)

L17C73 (Exp. 1/31/19)

F18E73 (Exp. 1/31/19)

Date Ranges: Expiration 1/31/19

Product: Doxycycline Hyclate USP Tablets, 100 mg (6-count bottle)

Model:

NDC 55289-866-06

Lot Numbers:

H17D70 (Exp. 1/31/19)

K17F66 (Exp. 1/31/19)

G18F26 (Exp. 1/31/19)

Date Ranges: Expiration 1/31/19

Product: Doxycycline Hyclate USP Tablets, 100 mg (7-count bottle)

Model:

NDC 55289-866-07

Lot Numbers:

C18G26 (Exp. 1/31/19)

F18E36 (Exp. 1/31/19)

Date Ranges: Expiration 1/31/19

Product: Doxycycline Hyclate USP Tablets, 100 mg (10-count bottle)

Model:

NDC 55289-866-10

Lot Numbers:

F18A85 (Exp. 1/31/19)

Date Ranges: Expiration 1/31/19

Product: Doxycycline Hyclate USP Tablets, 100 mg (14-count bottle)

Model:

NDC 55289-866-14

Lot Numbers:

K17B44 (Exp. 1/31/19)

K17E29 (Exp. 1/31/19)

L17D93 (Exp. 1/31/19)

E17B88 (Exp. 5/31/19)

H17A52 (Exp. 7/31/19)

H17D67 (Exp. 7/31/19)

Date Ranges: Expiration 1/31/19, Expiration 5/31/19, Expiration 7/31/19

Product: Doxycycline Hyclate USP Tablets, 100 mg (20-count bottle)

Model:

NDC 55289-866-20

Lot Numbers:

E17B01 (Exp. 5/31/19)

E17E83 (Exp. 5/31/19)

F17C99 (Exp. 6/30/19)

G17C08 (Exp. 7/31/19)

G17E18 (Exp. 7/31/19)

H17B01 (Exp. 7/31/19)

H17B66 (Exp. 7/31/19)

H17F67 (Exp. 7/31/19)

I17A56 (Exp. 7/31/19)

Date Ranges: Expiration 5/31/19, Expiration 6/30/19, Expiration 7/31/19

Product: Doxycycline Hyclate USP Tablets, 100 mg (28-count bottle)

Model:

NDC 55289-866-28

Lot Numbers:

E17E27 (Exp. 1/31/19)

I17A33 (Exp. 7/31/19)

G17D62 (Exp. 7/31/19)

Date Ranges: Expiration 1/31/19, Expiration 7/31/19

Product: Doxycycline Hyclate USP Tablets, 100 mg (30-count bottle)

Model:

NDC 55289-866-30

Lot Numbers:

E17B35 (Exp. 5/31/19)

E17D90 (Exp. 5/31/19)

F17C13 (Exp. 6/30/19)

G17B25 (Exp. 7/31/19)

H17C58 (Exp. 7/31/19)

Date Ranges: Expiration 5/31/19, Expiration 6/30/19, Expiration 7/31/19

Product: Doxycycline Hyclate USP Tablets, 100 mg (120-count bottle)

Model:

NDC 55289-866-98

Lot Numbers:

G17D59 (Exp. 7/31/19)

Date Ranges: Expiration 7/31/19

Product: Doxycycline Hyclate USP Tablets, 100 mg (300-count bottle)

Model:

NDC 55289-866-87

Lot Numbers:

I17A69 (Exp. 7/31/19)

G17D58 (Exp. 7/31/19)

Date Ranges: Expiration 7/31/19

Product: Doxycycline Hyclate USP Tablets, 100 mg (400-count bottle)

Model:

NDC 55289-866-74

Lot Numbers:

G17D56 (Exp. 7/31/19)

Date Ranges: Expiration 7/31/19

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80791

Status: Resolved

Manufacturer: PD-Rx Pharmaceuticals, Inc.

Sold By: Pharmacies; Healthcare providers

Manufactured In: United States

Units Affected: 6,641 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

Identify if you have the affected Doxycycline Hyclate USP Tablets (100 mg) by checking the NDC numbers and lot codes on your prescription bottle. Affected NDC numbers include: 55289-866-02, 55289-866-06, 55289-866-07, 55289-866-10, 55289-866-14, 55289-866-20, 55289-866-28, 55289-866-30, 55289-866-98, 55289-866-87, and 55289-866-74.

Check your bottle for the following lot numbers and expiration dates: D17D29, L17C73, F18E73, H17D70, K17F66, G18F26, C18G26, F18E36, F18A85, K17B44, K17E29, L17D93 (all Exp. 1/31/19); E17B88 (Exp. 5/31/19); H17A52, H17D67 (Exp. 7/31/19); E17B01, E17E83 (Exp. 5/31/19); F17C99 (Exp. 6/30/19); G17C08, G17E18, H17B01, H17B66, H17F67, I17A56, E17E27 (Exp. 1/31/19); I17A33, G17D62, E17B35, E17D90 (Exp. 5/31/19); F17C13 (Exp. 6/30/19); G17B25, H17C58, G17D59, I17A69, G17D58, and G17D56 (all Exp. 7/31/19).

If you find you have an affected lot, contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement prescription.

Return any unused tablets to the pharmacy where you purchased them for a refund and contact PD-Rx Pharmaceuticals at 1-800-299-7379 for further return instructions.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: Doxycycline Hyclate USP Tablets, 100 mg (2-count bottle)

Model:

NDC 55289-866-02

Lot Numbers:

D17D29 (Exp. 1/31/19)

L17C73 (Exp. 1/31/19)

F18E73 (Exp. 1/31/19)

Date Ranges: Expiration 1/31/19

Product: Doxycycline Hyclate USP Tablets, 100 mg (6-count bottle)

Model:

NDC 55289-866-06

Lot Numbers:

H17D70 (Exp. 1/31/19)

K17F66 (Exp. 1/31/19)

G18F26 (Exp. 1/31/19)

Date Ranges: Expiration 1/31/19

Product: Doxycycline Hyclate USP Tablets, 100 mg (7-count bottle)

Model:

NDC 55289-866-07

Lot Numbers:

C18G26 (Exp. 1/31/19)

F18E36 (Exp. 1/31/19)

Date Ranges: Expiration 1/31/19

Product: Doxycycline Hyclate USP Tablets, 100 mg (10-count bottle)

Model:

NDC 55289-866-10

Lot Numbers:

F18A85 (Exp. 1/31/19)

Date Ranges: Expiration 1/31/19

Product: Doxycycline Hyclate USP Tablets, 100 mg (14-count bottle)

Model:

NDC 55289-866-14

Lot Numbers:

K17B44 (Exp. 1/31/19)

K17E29 (Exp. 1/31/19)

L17D93 (Exp. 1/31/19)

E17B88 (Exp. 5/31/19)

H17A52 (Exp. 7/31/19)

H17D67 (Exp. 7/31/19)

Date Ranges: Expiration 1/31/19, Expiration 5/31/19, Expiration 7/31/19

Product: Doxycycline Hyclate USP Tablets, 100 mg (20-count bottle)

Model:

NDC 55289-866-20

Lot Numbers:

E17B01 (Exp. 5/31/19)

E17E83 (Exp. 5/31/19)

F17C99 (Exp. 6/30/19)

G17C08 (Exp. 7/31/19)

G17E18 (Exp. 7/31/19)

H17B01 (Exp. 7/31/19)

H17B66 (Exp. 7/31/19)

H17F67 (Exp. 7/31/19)

I17A56 (Exp. 7/31/19)

Date Ranges: Expiration 5/31/19, Expiration 6/30/19, Expiration 7/31/19

Product: Doxycycline Hyclate USP Tablets, 100 mg (28-count bottle)

Model:

NDC 55289-866-28

Lot Numbers:

E17E27 (Exp. 1/31/19)

I17A33 (Exp. 7/31/19)

G17D62 (Exp. 7/31/19)

Date Ranges: Expiration 1/31/19, Expiration 7/31/19

Product: Doxycycline Hyclate USP Tablets, 100 mg (30-count bottle)

Model:

NDC 55289-866-30

Lot Numbers:

E17B35 (Exp. 5/31/19)

E17D90 (Exp. 5/31/19)

F17C13 (Exp. 6/30/19)

G17B25 (Exp. 7/31/19)

H17C58 (Exp. 7/31/19)

Date Ranges: Expiration 5/31/19, Expiration 6/30/19, Expiration 7/31/19

Product: Doxycycline Hyclate USP Tablets, 100 mg (120-count bottle)

Model:

NDC 55289-866-98

Lot Numbers:

G17D59 (Exp. 7/31/19)

Date Ranges: Expiration 7/31/19

Product: Doxycycline Hyclate USP Tablets, 100 mg (300-count bottle)

Model:

NDC 55289-866-87

Lot Numbers:

I17A69 (Exp. 7/31/19)

G17D58 (Exp. 7/31/19)

Date Ranges: Expiration 7/31/19

Product: Doxycycline Hyclate USP Tablets, 100 mg (400-count bottle)

Model:

NDC 55289-866-74

Lot Numbers:

G17D56 (Exp. 7/31/19)

Date Ranges: Expiration 7/31/19