CLASS I Drug recall · Reported 19 Sep 2018 · FDA Enforcement Report
Hydrochlorothiazide Tablets USP, 12.5 mg recalled by Accord Healthcare
Accord Healthcare is recalling Hydrochlorothiazide Tablets USP, 12.5 mg, distributed nationwide in the US. The recall was initiated on 21 Aug 2018 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1206-2018
- FDA event ID
- 80850
- Recalling firm
- Accord Healthcare, Durham, NC
- Brand
- Hydrochlorothiazide
- Manufacturer
- Accord Healthcare Inc.
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 21 Aug 2018
- FDA classified
- 21 Sep 2018
- Reported
- 19 Sep 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Blood Pressure Medication
Timeline
| 21 Aug 2018 | Recall initiated by company | |
| 19 Sep 2018 | Published in enforcement report | +29 days |
| 21 Sep 2018 | Classified by FDA | +2 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product Mix-Up: customer complaint that a sealed bottle labeled as Hydrochlorothiazide Tablets USP 12.5 mg contained only Spironolactone Tablets USP 25 mg.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Hydrochlorothiazide Tablets USP, 12.5 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703; Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, India; NDC 16729-182-01.
Where it was distributed
Nationwide in the USA and Puerto Rico.
Questions about this recall
Why was it recalled?
Product Mix-Up: customer complaint that a sealed bottle labeled as Hydrochlorothiazide Tablets USP 12.5 mg contained only Spironolactone Tablets USP 25 mg.
Which lots are affected?
Lot: PW05264, Exp. 11/2019
Where was it sold?
Nationwide in the USA and Puerto Rico.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Accord Healthcare
All 106| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg) recalledLevothyroxine Sodium | Accord Healthcare | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg) recalledLevothyroxine Sodium | Accord Healthcare | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg) recalledLevothyroxine Sodium | Accord Healthcare | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg) recalledLevothyroxine Sodium | Accord Healthcare | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg) recalledLevothyroxine Sodium | Accord Healthcare | Potency & Assay | Nationwide |
Other Hydrochlorothiazide recalls
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Hydrochlorothiazide 50mg tablets recalled by Calvin Scott & Company | Calvin Scott | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Hydrochlorothiazide 25mg tablets recalled by Calvin Scott & Company | Calvin Scott | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Hydrochlorothiazide Capsules, USP, 12.5 mg, 10 cap/blister recalled | Amerisource Health Services | Particulate Matter | Nationwide |
| Drug | CLASS II | Hydrochlorothiazide Capsules, USP, 12.5 mg recalled | Vintage Pharmaceuticals LLC | Particulate Matter | Nationwide |
| Drug | CLASS II | Hydrochlorothiazide Tablet USP 25 mg recalledHydrochlorothiazide | Unichem Pharmaceuticals Usa | Other | Nationwide |