Orphenadrine Citrate Extended Release Tablets, 100 mg a)100-count bottle, (NDC 0185-0022-01) b) 1000-count bottle, (NDC 0185-0022-10), Rx only, Manufactured by Sandoz Inc., Princeton, NJ 08540.

Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.

Recall #: D-1445-2014
Affected scope: 781,000 extended release tablets
Initiated: July 11, 2014

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

Sandoz Inc recalled Orphenadrine Citrate Extended Release Tablets, 100 mg a)100-count bottle, (NDC 0185-002… - a low-severity action.

Orphenadrine Citrate Extended Release Tablets, 100 mg a)100-count bottle, (NDC 0185-002… was recalled by Sandoz Inc in July 30, 2014. Reason: Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.. Check the official notice for the remedy. Verify recall #D-1445-2014 with the FDA Drug before acting.

The recall

Sandoz Inc issued this low-severity FDA Drug recall-Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing..

Low
severity level: Class III
classification: July 30, 2014
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-1445-2014 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, 1 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 low severity.

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

Product description

Orphenadrine Citrate Extended Release Tablets, 100 mg a)100-count bottle, (NDC 0185-0022-01) b) 1000-count bottle, (NDC 0185-0022-10), Rx only, Manufactured by Sandoz Inc., Princeton, NJ 08540.

Reason for recall

Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.

Recall Profile

Structured summary of the FDA Drug recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Low (Class III)
Status	Terminated
Recall number	D-1445-2014
Date reported	July 30, 2014
Date initiated	July 11, 2014
Recalling firm	Sandoz Inc
Firm location	Princeton, NJ
Affected scope	781,000 extended release tablets
Distribution	Nationwide

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-1445-2014) 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? ▼

Orphenadrine Citrate Extended Release Tablets, 100 mg a)100-count bottle, (NDC 0185-0022-01) b) 1000-count bottle, (NDC 0185-0022-10), Rx only, Manufactured by Sandoz Inc., Princeton, NJ 08540.. Recalled by Sandoz Inc. Units affected: 781,000 extended release tablets.

Why was this product recalled? ▼

Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on July 30, 2014. Severity: Low. Recall number: D-1445-2014.

Where was the recalled product distributed? ▼

Distribution: Nationwide.

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 (Low), closest by report date among other firms and states.

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Similar Children & Baby Products · nearest report date

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 July 30, 2014. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026