Medications & Supplements/Prescription Drugs

PD-Rx Pharmaceuticals, Inc.: Doxycycline Hyclate Tablets Recalled Due to Failed Dissolution Testing

Agency Publication Date: May 26, 2020

Summary

PD-Rx Pharmaceuticals, Inc. is recalling 14,030 bottles of Doxycycline Hyclate tablets USP (100 mg), a prescription antibiotic used to treat various bacterial infections. The recall was initiated because the tablets failed dissolution specifications, meaning they may not dissolve properly in the body to release the active medication. This issue affects multiple bottle sizes ranging from 6-count to 400-count containers distributed nationwide across the United States. Consumers should contact their healthcare provider or pharmacist regarding the effectiveness of their medication.

Risk

If the medication does not dissolve according to specifications, the drug may not be fully absorbed by the body. This could lead to lower-than-intended blood levels of the antibiotic, potentially resulting in a failure to treat the underlying bacterial infection effectively.

What You Should Do

Check your prescription bottle of Doxycycline Hyclate USP, 100 mg for the following NDC numbers: 55289-866-06, 55289-866-10, 55289-866-14, 55289-866-20, 55289-866-28, 55289-866-30, 55289-866-60, 55289-866-98, 55289-866-71, 55289-866-87, or 55289-866-74.
Verify the lot number and expiration date on your packaging against the affected list, which includes: L18B72 (Exp 12/31/2020), I18B83 (Exp 06/30/2020), H18B11 (Exp 06/30/2020), I18A53 (Exp 06/30/2020), J18F97 (Exp 10/31/2020), K18A33 (Exp 11/30/2020), K18D17 (Exp 11/30/2020), L18A11 (Exp 12/31/2020), L18A29 (Exp 12/31/2020), L18D81 (Exp 12/31/2020), H18F60 (Exp 06/30/2020), I18C26 (Exp 06/30/2020), I18D61 (Exp. 06/30/2020), J18B80 (Exp 10/31/2020), K18C97 (Exp 11/30/2020), L18B30 (Exp. 12/31/2020), L18D25 (Exp 12/31/2020), L18E50 (Exp 12/31/2020), I18D07 (Exp. 06/30/2020), J1E02 (Exp 10/31/2020), J18E62 (Exp 10/31/2020), K18E98 (Exp. 11/30/2020), L18C54 (Exp 12/31/2020), H18E18 (Exp. 06/30/2020), I18F94 (Exp. 09/30/2020), J18E42 (Exp. 10/31/2020), L18B56 (Exp. 12/31/2020), J18C84 (Exp. 10/31/2020), A19B70 (Exp. 01/31/2021), K18E92 (Exp. 11/30/2020), I18E80 (Exp. 06/30/2020), K18A19 (Exp. 11/30/2020), F18E11 (Exp. 06/30/2020), G18E66 (Exp. 06/30/2020), H18E72 (Exp. 06/30/2020), I18E75 (Exp. 09/30/2020), I18E95 (Exp. 09/30/2020), I18F64 (Exp. 09/30/2020), A19D44 (Exp. 08/31/2020), H18E76 (Exp. 06/30/2020), I18F21 (Exp. 09/30/2020), and L18B91 (Exp. 12/31/2020).
Contact your healthcare provider or pharmacist immediately to discuss whether your treatment has been affected and if you need a replacement prescription.
Return any unused tablets in the original packaging to the place of purchase for a refund.
For further questions or to facilitate a return, contact PD-Rx Pharmaceuticals, Inc. at 727 N Ann Arbor Ave, Oklahoma City, OK 73127.
If you have additional consumer safety concerns, 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

Full refund and healthcare consultation.

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 tablets USP, 100 mg (6-count)

Model:

NDC 55289-866-06

Lot Numbers:

L18B72 (Exp 12/31/2020)

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

Model:

NDC 55289-866-10

Lot Numbers:

I18B83 (Exp 06/30/2020)

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

Model:

NDC 55289-866-14

Lot Numbers:

H18B11 (Exp 06/30/2020)

I18A53 (Exp 06/30/2020)

J18F97 (Exp 10/31/2020)

K18A33 (Exp 11/30/2020)

K18D17 (Exp 11/30/2020)

L18A11 (Exp 12/31/2020)

L18A29 (Exp 12/31/2020)

L18D81 (Exp 12/31/2020)

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

Model:

NDC 55289-866-20

Lot Numbers:

H18F60 (Exp 06/30/2020)

I18C26 (Exp 06/30/2020)

I18D61 (Exp. 06/30/2020)

J18B80 (Exp 10/31/2020)

K18C97 (Exp 11/30/2020)

L18B30 (Exp. 12/31/2020)

L18D25 (Exp 12/31/2020)

L18E50 (Exp 12/31/2020)

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

Model:

NDC 55289-866-28

Lot Numbers:

I18D07 (Exp. 06/30/2020)

J1E02 (Exp 10/31/2020)

J18E62 (Exp 10/31/2020)

K18E98 (Exp. 11/30/2020)

L18C54 (Exp 12/31/2020)

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

Model:

NDC 55289-866-30

Lot Numbers:

H18E18 (Exp. 06/30/2020)

I18F94 (Exp. 09/30/2020)

J18E42 (Exp. 10/31/2020)

L18B56 (Exp. 12/31/2020)

Product: Doxycycline Hyclate tablets USP, 100 mg (60-count)

Model:

NDC 55289-866-60

Lot Numbers:

J18C84 (Exp. 10/31/2020)

A19B70 (Exp. 01/31/2021)

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

Model:

NDC 55289-866-98

Lot Numbers:

K18E92 (Exp. 11/30/2020)

Product: Doxycycline Hyclate tablets USP, 100 mg (210-count)

Model:

NDC 55289-866-71

Lot Numbers:

I18E80 (Exp. 06/30/2020)

K18A19 (Exp. 11/30/2020)

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

Model:

NDC 55289-866-87

Lot Numbers:

F18E11 (Exp. 06/30/2020)

G18E66 (Exp. 06/30/2020)

H18E72 (Exp. 06/30/2020)

I18E75 (Exp. 09/30/2020)

I18E95 (Exp. 09/30/2020)

I18F64 (Exp. 09/30/2020)

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

Model:

NDC 55289-866-74

Lot Numbers:

A19D44 (Exp. 08/31/2020)

H18E76 (Exp. 06/30/2020)

I18F21 (Exp. 09/30/2020)

L18B91 (Exp. 12/31/2020)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85724

Status: Resolved

Manufacturer: PD-Rx Pharmaceuticals, Inc.

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 14,030 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 prescription bottle of Doxycycline Hyclate USP, 100 mg for the following NDC numbers: 55289-866-06, 55289-866-10, 55289-866-14, 55289-866-20, 55289-866-28, 55289-866-30, 55289-866-60, 55289-866-98, 55289-866-71, 55289-866-87, or 55289-866-74.

Verify the lot number and expiration date on your packaging against the affected list, which includes: L18B72 (Exp 12/31/2020), I18B83 (Exp 06/30/2020), H18B11 (Exp 06/30/2020), I18A53 (Exp 06/30/2020), J18F97 (Exp 10/31/2020), K18A33 (Exp 11/30/2020), K18D17 (Exp 11/30/2020), L18A11 (Exp 12/31/2020), L18A29 (Exp 12/31/2020), L18D81 (Exp 12/31/2020), H18F60 (Exp 06/30/2020), I18C26 (Exp 06/30/2020), I18D61 (Exp. 06/30/2020), J18B80 (Exp 10/31/2020), K18C97 (Exp 11/30/2020), L18B30 (Exp. 12/31/2020), L18D25 (Exp 12/31/2020), L18E50 (Exp 12/31/2020), I18D07 (Exp. 06/30/2020), J1E02 (Exp 10/31/2020), J18E62 (Exp 10/31/2020), K18E98 (Exp. 11/30/2020), L18C54 (Exp 12/31/2020), H18E18 (Exp. 06/30/2020), I18F94 (Exp. 09/30/2020), J18E42 (Exp. 10/31/2020), L18B56 (Exp. 12/31/2020), J18C84 (Exp. 10/31/2020), A19B70 (Exp. 01/31/2021), K18E92 (Exp. 11/30/2020), I18E80 (Exp. 06/30/2020), K18A19 (Exp. 11/30/2020), F18E11 (Exp. 06/30/2020), G18E66 (Exp. 06/30/2020), H18E72 (Exp. 06/30/2020), I18E75 (Exp. 09/30/2020), I18E95 (Exp. 09/30/2020), I18F64 (Exp. 09/30/2020), A19D44 (Exp. 08/31/2020), H18E76 (Exp. 06/30/2020), I18F21 (Exp. 09/30/2020), and L18B91 (Exp. 12/31/2020).

Contact your healthcare provider or pharmacist immediately to discuss whether your treatment has been affected and if you need a replacement prescription.

Return any unused tablets in the original packaging to the place of purchase for a refund.

For further questions or to facilitate a return, contact PD-Rx Pharmaceuticals, Inc. at 727 N Ann Arbor Ave, Oklahoma City, OK 73127.

If you have additional consumer safety concerns, 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 tablets USP, 100 mg (6-count)

Model:

NDC 55289-866-06

Lot Numbers:

L18B72 (Exp 12/31/2020)

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

Model:

NDC 55289-866-10

Lot Numbers:

I18B83 (Exp 06/30/2020)

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

Model:

NDC 55289-866-14

Lot Numbers:

H18B11 (Exp 06/30/2020)

I18A53 (Exp 06/30/2020)

J18F97 (Exp 10/31/2020)

K18A33 (Exp 11/30/2020)

K18D17 (Exp 11/30/2020)

L18A11 (Exp 12/31/2020)

L18A29 (Exp 12/31/2020)

L18D81 (Exp 12/31/2020)

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

Model:

NDC 55289-866-20

Lot Numbers:

H18F60 (Exp 06/30/2020)

I18C26 (Exp 06/30/2020)

I18D61 (Exp. 06/30/2020)

J18B80 (Exp 10/31/2020)

K18C97 (Exp 11/30/2020)

L18B30 (Exp. 12/31/2020)

L18D25 (Exp 12/31/2020)

L18E50 (Exp 12/31/2020)

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

Model:

NDC 55289-866-28

Lot Numbers:

I18D07 (Exp. 06/30/2020)

J1E02 (Exp 10/31/2020)

J18E62 (Exp 10/31/2020)

K18E98 (Exp. 11/30/2020)

L18C54 (Exp 12/31/2020)

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

Model:

NDC 55289-866-30

Lot Numbers:

H18E18 (Exp. 06/30/2020)

I18F94 (Exp. 09/30/2020)

J18E42 (Exp. 10/31/2020)

L18B56 (Exp. 12/31/2020)

Product: Doxycycline Hyclate tablets USP, 100 mg (60-count)

Model:

NDC 55289-866-60

Lot Numbers:

J18C84 (Exp. 10/31/2020)

A19B70 (Exp. 01/31/2021)

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

Model:

NDC 55289-866-98

Lot Numbers:

K18E92 (Exp. 11/30/2020)

Product: Doxycycline Hyclate tablets USP, 100 mg (210-count)

Model:

NDC 55289-866-71

Lot Numbers:

I18E80 (Exp. 06/30/2020)

K18A19 (Exp. 11/30/2020)

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

Model:

NDC 55289-866-87

Lot Numbers:

F18E11 (Exp. 06/30/2020)

G18E66 (Exp. 06/30/2020)

H18E72 (Exp. 06/30/2020)

I18E75 (Exp. 09/30/2020)

I18E95 (Exp. 09/30/2020)

I18F64 (Exp. 09/30/2020)

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

Model:

NDC 55289-866-74

Lot Numbers:

A19D44 (Exp. 08/31/2020)

H18E76 (Exp. 06/30/2020)

I18F21 (Exp. 09/30/2020)

L18B91 (Exp. 12/31/2020)