Severity
Critical
CriticalClass ITerminated
FDA Drug recall · Reported September 19, 2018
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.
Product Mix-Up: customer complaint that a sealed bottle labeled as Hydrochlorothiazide Tablets USP 12.5 mg contained only Spironolactone Tablets USP 25 mg.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Accord Healthcare, Inc. recalled Hydrochlorothiazide Tablets USP, 12.5 mg, 100-count bottle, Rx Only, Manufactured for: Ac… - a critical-severity action.
Hydrochlorothiazide Tablets USP, 12.5 mg, 100-count bottle, Rx Only, Manufactured for: Ac… was recalled by Accord Healthcare, Inc. in September 19, 2018. Reason: Product Mix-Up: customer complaint that a sealed bottle labeled as Hydrochlorothiazide Tablets USP 12.5 mg co…. Check the official notice for the remedy. Verify recall #D-1206-2018 with the FDA Drug before acting.
The recall
Accord Healthcare, Inc. issued this critical-severity FDA Drug recall-Product Mix-Up: customer complaint that a sealed bottle labeled as Hydrochlorothiazide Tablets USP 12.5 mg co….
- Critical
- severity level
- Class I
- classification
- September 19, 2018
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-1206-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-1206-2018) was formally reported on September 19, 2018, with the manufacturer initiating the action on August 21, 2018. It is classified under Critical severity (Class I), with a current status of Terminated. Accord Healthcare, Inc. is listed as the recalling firm, operating out of Durham, NC. Federal records list the affected scope as 46,632 bottles.
The documented reason for this recall is: Product Mix-Up: customer complaint that a sealed bottle labeled as Hydrochlorothiazide Tablets USP 12.5 mg contained only Spironolactone Tablets USP 25 mg. Distribution data in the federal record shows the product reached: Nationwide in the USA and Puerto Rico.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Children & Baby Products recalls over time
Where this recall sits in its category - 3,731 children & baby products recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
46,632 bottles
Related Recalls
6
0 from same agency
Product description
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | D-1206-2018 |
| Date reported | September 19, 2018 |
| Date initiated | August 21, 2018 |
| Recalling firm | Accord Healthcare, Inc. |
| Firm location | Durham, NC |
| Affected scope | 46,632 bottles |
| Distribution | Nationwide in the USA and Puerto Rico. |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-1206-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Accord Healthcare, Inc.. Units affected: 46,632 bottles.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Drug on September 19, 2018. Severity: Critical. Recall number: D-1206-2018.
Where was the recalled product distributed? ▼
Distribution: Nationwide in the USA and Puerto Rico..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-1206-2018) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
CPSC Moderate
AMASKY Nursing Pillows Recalled Due to Risk of Serious Injury or Death from Suffocation; Violate Mandatory Standards fo…
Xishentang Dongguan Trading Co, Ltd., dba Pretty-Life, of China · 2026-07-02
CPSC Moderate
Diamond Wipes International Recalls CVS Health Medicated Hemorrhoidal Wipes Due to Risk of Serious Injury or Death from…
Diamond Wipes International, Inc. of Chino, California · 2026-07-02
CPSC Moderate
Junpower CR2032 Lithium Coin Batteries Recalled Due to Risk of Serious Injury or Death from Battery Ingestion Hazard; V…
· 2026-07-02
CPSC Moderate
Target Recalls Gigglescape™ Under the Sea Popping Toy Due to Choking Hazard
· 2026-07-02
CPSC Moderate
Vevor Recalls Baby Loungers Due to Risk of Serious Injury or Death from Entrapment and Fall Hazards; Violate Mandatory …
Sanven Technology Ltd., dba Vevor, of Rancho Cucamonga, California · 2026-07-02
Compare this recall with AMASKY Nursing Pillows Recalled Due to Risk of Serious Inju… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported September 19, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.