Nationwide Laboratories Recall: Phenazopyridine Tablets May Have Manufacturing Issues
Nationwide Laboratories recalls 200mg phenazopyridine hydrochloride tablets (Rx only) due to potential assay or content uniformity failures in manufacturing. This may affect safety but does not cause immediate harm.
Lower-risk recall
CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
Contact the company
What happened, in plain English
Nationwide Laboratories is recalling 100-count bottles of 200mg phenazopyridine hydrochloride tablets (Rx only) because manufacturing practices may result in inconsistent drug content. This could affect the medication's effectiveness but does not pose an immediate safety risk. Read more at govinfonow.com/recall/42269-nationwide-laboratories-recall-phenazopyridine-tablets-may-have-manufacturing-issues.
Source Summary by GovInfoNow · govinfonow.com/recall/42269-nationwide-laboratories-recall-phenazopyridine-tablets-may-have-manufacturing-issues · Updated October 9, 2026 · FDA enforcement record: FDA #D-0168-2017
Cite this page
“Nationwide Laboratories Recall: Phenazopyridine Tablets May Have Manufacturing Issues.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42269-nationwide-laboratories-recall-phenazopyridine-tablets-may-have-manufacturing-issues. Based on FDA recall #D-0168-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0168-2017%22&limit=1).
Why it’s dangerous
The manufacturing process may produce tablets with inconsistent drug content, potentially affecting the medication's effectiveness. However, this does not cause immediate harm or injury in normal use.
Who’s affected
Prescription patients who have received these specific 200mg phenazopyridine hydrochloride tablets from Nationwide Laboratories. Those with chronic urinary tract conditions may be most affected due to medication requirements.
How to tell if you have this one
Check for 100-count bottles labeled 'Phenazopyridine Hydrochloride Tablets, USP, 200 mg' with NDC 42937-702-10. Lot numbers 28181501-28181601 and expiration dates up to March 2017.
- Brand
Nationwide Laboratories- Category
Drug
All 4 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 in USA and Puerto Rico
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0165-2017 | Salsalate Tablets, USP, 500 mg, packaged in a) 500 count bottles (NDC 42937-703-18); b) 100 count bottles (NDC 42937-703-10); and c) 1000 count bottles (NDC 42937-703-20); Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830.; Lot #: a) 28121501, 28121502, 28121503, 28121504, Exp 03/17; 28121505, Exp 06/17; 28121506, 28121507, Exp 09/17; b) 28121503, 28121504, Exp 03/17; 28121505, Exp 06/17; 28121506, 28121507, Exp 09/17; c) 28121505, Exp 06/17; 28121506, 28121507, Exp 09/17 | 2,882,661 tablets |
| D-0166-2017 | Salsalate Tablets, USP, 750 mg, packaged in a) 100 count bottles (NDC 42937-704-10); b) 500 count bottles (NDC 42937-704-18); and c) 1000 count bottles (NDC 42937-704-20); Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830.; Lot #: a) 28141502, 28141503, 28141504, 28141505, 28141506, Exp 03/17; 28141507, Exp 09/17; 28141508, 28141510, 28141511, Exp 10/17; b) 28141502, 28141504, 28141506, Exp 03/17; 28141507, Exp 09/17; 28141508, 28141510, 28141511, Exp 10/17; c) 28141501, 28141502, 28141504, 28141506, Exp 03/17; 28141507, Exp 09/17; 28141508, 28141510, 28141511, Exp 10/17 | 2,514,500 tablets |
| D-0167-2017 | Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830, NDC 42937-701-10.; Lot #: 28161501, Exp 03/17; 28161502, 28161503, Exp 08/17; 28161601, 28161602, Exp 01/18 | 6,333,669 tablets |
| D-0168-2017 | Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830, NDC 42937-702-10.; Lot #: 28181501, 28181502, Exp 03/17; 28181503, 28181504, Exp 08/17; 28181505, 28181506, Exp 09/17; 28181601, Exp 01/18 | 5,786,653 tablets |
What to do — step by step
Check Medication Details
Verify the product label, NDC number, and lot numbers to confirm if your tablets are affected.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in USA and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 19 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using these tablets?
No, but you should check if your tablets are affected and contact your doctor if you have concerns.
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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-0168-2017 (October 28, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0168-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 9, 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.