CLASS III Drug recall · Reported 30 Jul 2014 · FDA Enforcement Report
Orphenadrine Citrate Extended Release Tablets, 100 mg a) recalled
Sandoz is recalling Orphenadrine Citrate Extended Release Tablets, 100 mg a), (, distributed nationwide in the US. The recall was initiated on 11 Jul 2014 and the FDA has classified it as Class III.
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-1445-2014
- FDA event ID
- 68860
- Recalling firm
- Sandoz, Princeton, NJ
- Brand
- Orphenadrine Citrate
- Manufacturer
- Sandoz Inc
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 11 Jul 2014
- FDA classified
- 23 Jul 2014
- Reported
- 30 Jul 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 11 Jul 2014 | Recall initiated by company | |
| 23 Jul 2014 | Classified by FDA | +12 days |
| 30 Jul 2014 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
Which lots are affected?
Lot # DM1316; Exp. 05/16 Lot # DM1318; Exp. 05/16
Where was it sold?
Nationwide
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
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Other Orphenadrine recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Orphenadrine Citrate Extended-Release Tablets, USP 100 mg recalledOrphenadrine Citrate | Sandoz | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Orphenadrine Citrate ER Tablet, 100 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |