Class II · Moderate risk
Orphenadrine Citrate Extended-Release Tablets
CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.
Is Orphenadrine recalled?
Not under an active recall.
Orphenadrine was recalled 5 times in the past — all now closed. Most recent: Mar 21, 2022.
Most common reason: Cross-contamination (1 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Orphenadrine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Orphenadrine recalls on record
none so far in 2026; 5 on record, newest first
Class II · Moderate risk
Orphenadrine Citrate Sterile Injectable Solution *Contains Sulfites*
Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Class II · Moderate risk
Orphenadrine Citrate active pharmaceutical ingredient packaged in…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class III · Low risk
Orphenadrine Citrate Extended Release Tablets
Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
Class II · Moderate risk
ORPHENADRINE CITRATE ER Tablet
Labeling: Label Mixup; ORPHENADRINE CITRATE ER Tablet, 100 mg may be potentially mislabeled as OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 40985022921, Pedigree: W002965, EXP: 6/10/2014.
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