PD-Rx Pharmaceuticals Clonidine Hydrochloride Tablets Recall

Why it was recalled

cGMP Deviations

Product description

Clonidine Hydrochloride Tablets, USP, 0.1 mg, 100-count bottles, Rx only, Packaged by PD-RX Pharmaceuticals, Inc., Oklahoma City, OK 73127, MFG: Mutual Pharm. Co. Inc., Philadelphia, PA 19124, NDC 43063-509-01

Lot numbers, UPCs & expiration codes

Lot# B14D26, Exp 02/16

Where it was sold

Alabama

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0559-2016
Classification: Class II
Status: Terminated
Recall initiated: Jul 10, 2015
FDA report date: Jan 6, 2016
Quantity: 9 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: PD-Rx Pharmaceuticals, Inc.

Original FDA data

Every field from FDA enforcement report D-0559-2016, exactly as published.

Show all FDA fields

City: Oklahoma City
State: OK
Status: Terminated
Country: United States
Event ID: 72942
Address: 727 N Ann Arbor Ave
Code information: Lot# B14D26, Exp 02/16
Postal code: 73127-5822
Report date: Jan 6, 2016
Product type: Drugs
Recall number: D-0559-2016
Classification: Class II
Recalling firm: PD-Rx Pharmaceuticals, Inc.
Product quantity: 9 bottles
Termination date: Mar 8, 2017
Reason for recall: cGMP Deviations
Voluntary / mandated: Voluntary: Firm initiated
Product description: Clonidine Hydrochloride Tablets, USP, 0.1 mg, 100-count bottles, Rx only, Packaged by PD-RX Pharmaceuticals, Inc., Oklahoma City, OK 73127, MFG: Mutual Pharm. Co. Inc., Philadelphia, PA 19124, NDC 43063-509-01
Distribution pattern: Alabama
Recall initiation date: Jul 10, 2015
Initial firm notification: E-Mail
Center classification date: Dec 31, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0559-2016, published Jan 6, 2016. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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