Class II · Moderate risk
Minocycline Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
Is Minocycline recalled?
Yes — there is an active recall. 1 ongoing FDA recall mention Minocycline (10 total). Check the affected lots below.
Most common reason: cGMP deviation (3 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Minocycline. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Minocycline recalls in 2026
1 initiated in 2026, 10 in total — newest first
Class II · Moderate risk
minolira (minocycline hydrochloride)
CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Class II · Moderate risk
minolira (minocycline hydrochloride)
CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Class III · Low risk
Minocycline Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications: low out of specification results for dissolution testing.
Class III · Low risk
minolira (minocycline hydrochloride)
Failed Dissolution Specifications:
Class II · Moderate risk
All minocycline Products
Lack of Processing Controls
Class III · Low risk
Minocycline Hydrochloride Capsules USP
Labeling: Incorrect or Missing Lot and/or Exp Date: the individual blisters are mislabeled with an incorrect lot number of 13560 rather than the correct lot number of 13650.
Class II · Moderate risk
Minocycline 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
Minocycline HCL
Labeling: Label Mixup: MINOCYCLINE HCL, Capsule, 100 mg may have potentially been mislabeled as the following drug: PROGESTERONE, Capsule, 100 mg, NDC 00591396401, Pedigree: AD73611_4, EXP: 5/30/2014.
Class II · Moderate risk
Minocycline HCL
Labeling: Label Mixup: MINOCYCLINE HCL, Capsule, 50 mg may have potentially been mislabeled as the following drug: MINOXIDIL, Tablet, 2.5 mg, NDC 00591564201, Pedigree: AD52778_49, EXP: 5/20/2014.
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