FDA Recalls Orphenadrine Citrate Tablets Due to Nitrosamine Impurity
Sandoz is recalling Orphenadrine Citrate Extended-Release Tablets due to nitrosamine impurity levels exceeding acceptable daily limits. Affected patients should consult their healthcare provider.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for nitrosamine impurity above acceptable daily limits in a prescription drug. Nitrosamine is a known carcinogenic substance; the recall addresses manufacturing deviations with no reported illnesses to date, fitting the criterion of risk-of-harm products where injury has not yet been reported.
Plain-English summary
Sandoz, Inc. is recalling Orphenadrine Citrate Extended-Release Tablets, USP 100 mg due to nitrosamine impurity (NMOA) detected above acceptable daily limits. This represents a Current Good Manufacturing Practice (CGMP) deviation.
The recalled product consists of 7,908 bottles (790,800 tablets) distributed nationwide. The affected lots include JX6411, JX6413, KC0723, KC3303, KE4348, KE7169, KE4349, KL3199, KM0072, KS3939, LA7704, LA7703, and LA9243, with expiration dates ranging from May 2022 through November 2023.
Orphenadrine Citrate is a muscle relaxant medication prescribed for musculoskeletal pain. Patients taking affected lots should contact their healthcare provider for guidance on continued use. Consumers should not discontinue use without consulting their doctor, as abrupt discontinuation may be harmful.
Patients or healthcare providers who have experienced adverse effects related to this product should report the event to the FDA MedWatch program.
The recalled product
- Product
- ORPHENADRINE CITRATE (ORPHENADRINE CITRATE)
- Brand
- ORPHENADRINE CITRATE
- Manufacturer
- Sandoz, Inc
- Hazard
- nitrosamine-impurity
- carcinogenic-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (14)
- 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
Distribution
Distributed nationwide across the United States.
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