CLASS II Drug recall · Reported 13 Apr 2022 · FDA Enforcement Report
Orphenadrine Citrate Extended-Release Tablets, USP 100 mg recalled
Sandoz is recalling Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, distributed nationwide in the US. The recall was initiated on 21 Mar 2022 and the FDA has classified it as Class II.
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-0753-2022
- FDA event ID
- 88937
- Recalling firm
- Sandoz, Princeton, NJ
- Brand
- Orphenadrine Citrate
- Manufacturer
- Sandoz Inc
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Mar 2022
- FDA classified
- 6 Apr 2022
- Reported
- 13 Apr 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Nitrosamine Impurity
Timeline
| 21 Mar 2022 | Recall initiated by company | |
| 6 Apr 2022 | Classified by FDA | +16 days |
| 13 Apr 2022 | 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
CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.
Nitrosamines are impurities that can form during drug manufacturing or storage. Above the FDA acceptable intake limit, long-term exposure may raise cancer risk. The FDA advises patients to keep taking the medicine until they have a replacement.
Product as listed by the FDA
Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets, Manufactured by Sandoz Inc., Princeton, NJ 08540 NDC 0185-0022-01.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.
Which lots are affected?
Lot #: JX6411, JX6413, Exp. 05/2022 Lot #: KC0723,KC3303, Exp. 08/2022 Lot #: KE4348, KE7169,KE4349, Exp. 11/2022 Lot #: KL3199, KM0072,KS3939, Exp. 03/2023 Lot #: LA7704, LA7703,LA9243, Exp. 11/2023
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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 III | Orphenadrine Citrate Extended Release Tablets, 100 mg a) recalledOrphenadrine Citrate | Sandoz | Potency & Assay | Nationwide |
| Drug | CLASS II | Orphenadrine Citrate ER Tablet, 100 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |