Class II · Moderate risk
Amantadine HCl
Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
Is Amantadine recalled?
Yes — there is an active recall. 2 ongoing FDA recalls mention Amantadine (9 total). Check the affected lots below.
Most common reason: Labeling / mix-up (3 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Amantadine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Amantadine recalls in 2026
1 initiated in 2026, 9 in total — newest first
Class II · Moderate risk
Amantadine Hydrochloride Oral Solution USP
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Amantadine Hydrochloride Tablets 100 mg 100-count bottle
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Amantadine Hydrochloride Tablets
Presence of Foreign Substance: Presence of a foreign object in a single tablet.
Class II · Moderate risk
Amantadine HCl Capsules
Failed Dissolution Specifications
Class II · Moderate risk
Amantadine HCl Capsules
Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg
Class II · Moderate risk
Amantadine HCl 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 II · Moderate risk
Amantadine HCL
Labeling: Label Mixup: AMANTADINE HCL, Tablet, 100 mg may have potentially been mislabeled as one of the following drugs: MAGNESIUM CHLORIDE, Tablet, 64 mg, NDC 68585000575, Pedigree: AD52993_4, EXP: 5/17/2014; QUEtiapine FUMARATE, Tablet, 25 mg, NDC 65862048901, Pedigree: AD49582_22, EXP: 4/30/2014.
Class II · Moderate risk
Amantadine HCL
Labeling: Label Mixup: AMANTADINE HCL, Capsule, 100 mg may have potentially been mislabeled as one of the following drugs: ACARBOSE, Tablet, 25 mg, NDC 00054014025, Pedigree: W002725, EXP: 6/6/2014; clomiPRAMINE HCl, Capsule, 50 mg, NDC 51672401205, Pedigree: W002998, EXP: 6/11/2014; ASPIRIN EC DR, Tablet, 81 mg, NDC 49348098015, Pedigree: W003672, EXP: 2/28/2014; NIACIN TR, Capsule, 500 mg, N
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