Yes — there is an active recall. 2 ongoing FDA recalls mention Theophylline (5 total). Check the affected lots below.
Most common reason: Dissolution failure (2 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Theophylline. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for commercial annual stability at the long-term shelf life stability interval, wherein the dissolution results do not comply with L3 stage dissolution criteria.
OOS results reported for the Dissolution (by UV) test.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
CGMP Deviations: poor manufacturing practices resulted in Labeling: Incorrect or Missing Lot and/or Exp Date, product incorrectly labeled with incorrect lot and expiration date.
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.
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