ModerateClass IITerminated

FDA Drug recall · Reported May 20, 2015

SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP 800 mg/ 160 mg per 5mL, GRAPE FLAVOR, 20 mL unit dose cup (NDC 50383-0824-20), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701

Q: Which agency issued this recall?

This recall was issued by the FDA Drug on May 20, 2015. Severity: Moderate. Recall number: D-0997-2015.

Q: Where was the recalled product distributed?

Distribution: Nationwide and Puerto Rico.

Q: 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.

Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.

Recall #: D-0997-2015
Affected scope: 8,400 unit dose cups (20 mL each)
Initiated: March 17, 2015

Compiled from official public sources by the publisher. · Updated September 2026

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Akorn, Inc. recalled SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP 800 mg/ 160 mg per 5mL, GRAPE FLAV… - a moderate-severity action.

SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP 800 mg/ 160 mg per 5mL, GRAPE FLAV… was recalled by Akorn, Inc. in May 20, 2015. Reason: Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.. Check the official notice for the remedy. Verify recall #D-0997-2015 with the FDA Drug before acting.

The recall

Akorn, Inc. issued this moderate-severity FDA Drug recall-Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole..

Moderate
severity level: 8K units
affected scope: Class II
classification: May 20, 2015
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-0997-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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, 6 from FDA Drug - 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.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP 800 mg/ 160 mg per 5mL, GRAPE FLAVOR, 20 mL unit dose cup (NDC 50383-0824-20), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701

Reason for recall

Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.

Recall Profile

Structured summary of the FDA Drug recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	D-0997-2015
Date reported	May 20, 2015
Date initiated	March 17, 2015
Recalling firm	Akorn, Inc.
Firm location	Lake Forest, IL
Affected scope	8,400 unit dose cups (20 mL each)
Distribution	Nationwide and Puerto Rico

Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

8,400 unit dose cups (20 mL each) units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (D-0997-2015) 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.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. 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? ▼

SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP 800 mg/ 160 mg per 5mL, GRAPE FLAVOR, 20 mL unit dose cup (NDC 50383-0824-20), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701. Recalled by Akorn, Inc.. Units affected: 8,400 unit dose cups (20 mL each).

Why was this product recalled? ▼

Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on May 20, 2015. Severity: Moderate. Recall number: D-0997-2015.

Where was the recalled product distributed? ▼

Distribution: Nationwide and Puerto Rico.

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.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Moderate), closest by report date among other firms and states.

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Same product category, closest by report date among other firms and states (deduped against the severity set).

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This recall: FDA Drug, reported May 20, 2015. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026