Use caution Drug recall · FDA · Published April 29, 2015

PD-Rx Azithromycin Recall: cGMP Deviations in 250mg Tablets

PD-Rx recalls Azithromycin 250mg tablets due to cGMP deviations. Check lot numbers and expiration dates for affected bottles distributed nationwide.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0560-2016Drug PD-Rx Pharmaceuticals ›

Use caution until it’s fixed

cGMP Deviations: This recall is a result of the original manufacturer's recall, in which the firm did not adequately investigate customer complaints.

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 is recalling Azithromycin Tablets, USP, 250 mg because the original manufacturer did not adequately investigate customer complaints, leading to current Good Manufacturing Practice (cGMP) deviations. The recall affects specific lots of 2-count and 4-count bottles distributed nationwide. While the record does not specify a direct physical hazard or injury risk, the deviation raises concerns about product quality and consistency. Read more at govinfonow.com/recall/44719-pd-rx-pharmaceuticals-inc-recalls-azithromycin-tablets-usp-250-mg.

Source Summary by GovInfoNow · govinfonow.com/recall/44719-pd-rx-pharmaceuticals-inc-recalls-azithromycin-tablets-usp-250-mg · Updated October 12, 2026 · FDA enforcement record: FDA #D-0560-2016

Cite this page

“PD-Rx Azithromycin Recall: cGMP Deviations in 250mg Tablets.” GovInfoNow, updated October 12, 2026. https://govinfonow.com/recall/44719-pd-rx-pharmaceuticals-inc-recalls-azithromycin-tablets-usp-250-mg. Based on FDA recall #D-0560-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0560-2016%22&limit=1).

The FDA announced on April 29, 2015, that PD-Rx Pharmaceuticals is recalling Azithromycin Tablets, USP, 250 mg due to current good manufacturing practice deviations. The agency stated the firm did not adequately investigate customer complaints. Owners should contact the company for further instructions.

How to tell if you have it

Brand: PD-Rx Pharmaceuticals
Product: Azithromycin Tablets, USP, 250 mg
Packaging: 2 count and 4 count bottles
NDCs: 55289-964-02 (2 count), 55289-964-04 (4 count)
Lots: J12A48, L12A23, A13G04, A13H14, B13E97, C13B55, J13F75, L13C93, A14F78, A14H17, B14A6, I13D47, I13G28, J13D73, J13D93, K13E18, 11/15, A14H06, C14A49, C14D01, A14B95
Distribution: Nationwide

The hazard

The recall stems from cGMP deviations where the firm failed to adequately investigate customer complaints. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show PD-Rx Pharmaceuticals has issued 16 other recalls since July 10, 2015. Recent brand recalls include a December 4, 2024, Duloxetine recall for nitrosamine impurity risk and an April 6, 2023, Simvastatin recall for cGMP deviations. Other recent recalls of similar products include an Ajanta Pharma Fenofibrate Capsules Recall (May 28, 2026) and Wells Pharma Fentanyl Citrate Recalls (April 1, 2026).

How to tell if you have this one

Look for Azithromycin Tablets, USP, 250 mg, Rx Only, packaged in 2-count or 4-count bottles. The product is packaged by PD-Rx Pharmaceuticals, Inc., Oklahoma City, OK. Check the NDC numbers (55289-964-02 or 55289-964-04) and specific lot numbers such as J12A48, L12A23, A13G04, A13H14, B13E97, C13B55, J13F75, L13C93, A14F78, A14H17, B14A6, I13D47, I13G28, J13D73, J13D93, K13E18, A14H06, C14A49, C14D01, and A14B95.

Brand
PD-Rx Pharmaceuticals
Category
Drug

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
Nationwide

Recall number	Product, codes & lots	Quantity
D-0560-2016	Azithromycin Tablets, USP, 250 mg, Rx Only, packaged in a) 2 count and b) 4 count bottles, Packaged by: PD-RX Pharmaceuticals, Inc., Oklahoma City, OK, 73127, Mfg: Wockhardt Ltd., Mumbai, India, NDC: a) 55289-964-02, b) 55289-964-04.; Lot #s: a) J12A48, Exp 10/14, L12A23, Exp 12/14, A13G04, A13H14, Exp 01/15, B13E97, Exp 02/15, C13B55, Exp 03/15, J13F75, L13C93, A14F78, A14H17, B14A6, Exp 08/15, I13D47, I13G28, Exp 09/15, J13D73, J13D93 Exp 10/15, K13E18, 11/15, A14H06, C14A49, C14D01, Exp 12/15, A14B95 01/16.	45,022 bottles
D-0561-2016	Azithromycin 500 mg tablets, Rx Only, packaged in a) 1 count, b) 2 count, c) 3 count, and d) 7 count bottles, Packaged by: PD-RX Pharmaceuticals, Inc., Oklahoma City, OK 73127, Mfr: Wokhardt Ltd., Mumbai, India, NDC: a) 55289-274-79, b) 55289-274-02, c) 55289-274-03, d) 55289-274-07.; Lot #s: J12C03, J12D19, Exp 10/14, L12B52, L12E79, L12G92, Exp 12/14, A13G14, A13H49, Exp 01/15, B13G53, Exp 02/15, D13A66, Exp 04/15, E13E35, Exp 05/15, F13A58, F13D85, F13F17, F13F27, Exp 06/15, G13D37, G13E57, Exp 07/15, H13A65, H13A74, H13C13, H13G01, Exp 08/15, I13C02, I13G98, Exp 09/15, J13C53, J13G90, Exp 10/15, K13A65, K13B73, K13C98, K13E61, Exp 11/15, L13C59, L13F49, A14C27, A14D09, A14F11, Exp 12/15.	17,533 bottles

Based on the official FDA remedy

What to do — step by step

Check Your Medication
Verify if your Azithromycin tablets match the recalled NDC numbers (55289-964-02 or 55289-964-04) and lot numbers listed in the record.
Contact Your Pharmacist
Speak with your pharmacist or healthcare provider to determine if you have an affected product and what alternative treatment options are available.

Where it went and when

Where it was distributed

Distributed nationwide.

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

Distributed nationwide.

Recall timeline

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

Apr 29, 2015Firm started the recall
Jan 5, 2016FDA classified it Class II
Jan 13, 2016Published in FDA’s Enforcement Report
Dec 23, 2016FDA terminated the recall

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

Similar recalls

Latest drug recalls

Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/44719-pd-rx-pharmaceuticals-inc-recalls-azithromycin-tablets-usp-250-mg">PD-Rx Azithromycin Recall: cGMP Deviations in 250mg Tablets (GovInfoNow)</a>

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-0560-2016 (April 29, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0560-2016 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.