Skip to content
Use caution Drug recall · FDA · Published July 10, 2015

PD-Rx Recalls Clonidine Tablets Due to cGMP Deviations

PD-Rx Pharmaceuticals recalls 9 bottles of 0.1 mg Clonidine Hydrochloride Tablets due to current Good Manufacturing Practice deviations.

🇺🇸 FDA recall #D-0559-2016DrugPD-Rx Pharmaceuticals ›
Take action

Contact the company

Recalling firmPD-Rx Pharmaceuticals, Inc.727 N Ann Arbor Ave · Oklahoma City, OK 73127-5822
✎ GovInfoNow plain-language explainer

PD-Rx Pharmaceuticals, Inc. is recalling 9 bottles of Clonidine Hydrochloride Tablets, USP, 0.1 mg, packaged in 100-count bottles. The recall was initiated because the product was manufactured with current Good Manufacturing Practice (cGMP) deviations. These deviations may affect the quality and safety of the medication. Read more at govinfonow.com/recall/44099-pd-rx-pharmaceuticals-inc-recalls-clonidine-hydrochloride-tablets-usp-0.

Source Summary by GovInfoNow · govinfonow.com/recall/44099-pd-rx-pharmaceuticals-inc-recalls-clonidine-hydrochloride-tablets-usp-0 · Updated October 12, 2026 · FDA enforcement record: FDA #D-0559-2016

Cite this page

“PD-Rx Recalls Clonidine Tablets Due to cGMP Deviations.” GovInfoNow, updated October 12, 2026. https://govinfonow.com/recall/44099-pd-rx-pharmaceuticals-inc-recalls-clonidine-hydrochloride-tablets-usp-0. Based on FDA recall #D-0559-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0559-2016%22&limit=1).

PD-Rx Pharmaceuticals, Inc. recalled Clonidine Hydrochloride Tablets, USP, 0.1 mg, 100-count bottles on July 10, 2015, due to current Good Manufacturing Practice deviations, the Food and Drug Administration said. The recall affects nine bottles distributed in Alabama.

How to tell if you have it

  • Brand: PD-Rx Pharmaceuticals
  • Product: Clonidine Hydrochloride Tablets, USP, 0.1 mg, 100-count bottles
  • NDC: 43063-509-01
  • Lot#: B14D26
  • Expiration: 02/16
  • Manufacturer: Mutual Pharm. Co. Inc., Philadelphia, PA 19124
  • Packager: PD-RX Pharmaceuticals, Inc., Oklahoma City, OK 73127
  • Distribution: Alabama
  • Quantity: 9 bottles

The hazard

The recall is due to current Good Manufacturing Practice deviations. The FDA classified the recall as Class II.

Context

GovInfoNow's records show PD-Rx Pharmaceuticals, Inc. has had 16 other recalls on record since April 29, 2015. Other recent recalls of similar products include a Duloxetine 30mg recall (Dec. 4, 2024), a Simvastatin 40mg recall (April 6, 2023), and a Losartan Tablets recall (June 6, 2022). Other recent recalls of similar products include a Fentanyl Citrate Injectable Solution recall by Wells Pharma (April 1, 2026), a Globe Clotrimazole Cream recall by Blossom Pharmaceuticals (Oct. 31, 2025), and a Clindamycin Injection recall by Baxter (Aug. 6, 2026).

How to tell if you have this one

Check your medication bottle for the following details: Brand/Packager PD-Rx Pharmaceuticals, Inc.; NDC 43063-509-01; Lot# B14D26; Expiration date 02/16. The product is Clonidine Hydrochloride Tablets, USP, 0.1 mg in 100-count bottles.

  • Brand
    PD-Rx Pharmaceuticals
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Your Medication

    Verify if your bottle matches NDC 43063-509-01, Lot# B14D26, and expires on 02/16.

  2. Contact Your Pharmacist

    Speak with your pharmacist or healthcare provider to determine if you have the recalled lot and what steps to take next.

Where it went and when

Where it was distributed

Distributed in Alabama.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: yesALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFL

FDA distribution: “Alabama” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama.

Recall timeline

FDA terminated this recall 20 months after the firm started it.

1. Firm started the recall: Jul 10, 201512. FDA classified it Class II: Dec 31, 201523. Published in FDA’s Enforcement Report: Jan 6, 201634. FDA terminated the recall: Mar 8, 2017420152017
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest drug recalls

Keep exploring

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0559-2016 (July 10, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0559-2016 to see it in context.
  • Plain-language summary written by qwen3.6:35b-a3b on October 12, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA