CLASS IIDrug recall · Reported 24 Oct 2018 · FDA Enforcement Report
CVS Health, Original Strength recalled by Product Quest Manufacturing
Product Quest Manufacturing is recalling CVS Health, Original Strength, Triple Antibiotic Ointment Spray (bacitracin zinc, distributed nationwide in the US. The recall was initiated on 3 Aug 2018 and the FDA has classified it as Class II.
Check your package
Lot, batch or date codesLot: 170591E, Exp. 11/17/18
Quantity recalled11,016 cans
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug: low out of specification assay results for the bacitracin zinc ingredient.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
CVS Health, Original Strength, Triple Antibiotic Ointment Spray (bacitracin zinc 400 units, neomycin sulfate 3.5 mg, polymyxin B sulfate 5,000 units per gram), 2 OZ (57 g) can, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Product#957603, UPC 0 50428 29525 0.
Subpotent Drug: low out of specification assay results for the bacitracin zinc ingredient.
Which lots are affected?
Lot: 170591E, Exp. 11/17/18
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.