Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Is Erythromycin recalled?

Yes — there is an active recall. 6 ongoing FDA recalls mention Erythromycin (14 total). Check the affected lots below.

Most common reason: Impurity / degradation (3 of these recalls)

Recalls are matched by product description. A recall usually affects specific lots, not every package of Erythromycin. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.

Erythromycin recalls in 2026

2 initiated in 2026, 14 in total — newest first
Class II · Moderate risk

Erythromycin Tablets

CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit

Ongoing Nitrosamine impurity Zydus Pharmaceuticals (USA) Inc NDC 70710-1048-3 D-0545-2026
Class II · Moderate risk

Erythromycin Tablets

CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit

Ongoing Nitrosamine impurity Zydus Pharmaceuticals (USA) Inc NDC 70710-1047-3 D-0544-2026
Class II · Moderate risk

Erythromycin Topical Gel USP

CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.

Ongoing Stability / shelf life McKesson Corporation dba McKesson Drug Company NDC 63739-053-68 D-0851-2022
Class II · Moderate risk

Erythromycin Topical Gel USP

Failed Impurities/Degradation Specifications: Lot not meeting specification for Unknown Max Related Compounds.

Terminated Impurity / degradation Teligent Pharma, Inc. NDC 63739-053-66 D-0716-2022
Class II · Moderate risk

Erythromycin Tablets

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Terminated Temperature excursion Cardinal Health Inc. D-0424-2021
Class II · Moderate risk

Erythromycin Pledgets USP

Microbial Contamination of Non-Sterile Products: Active Pharmaceutical Ingredient (API) failed USP microbial tests.

Terminated Microbial contamination Akorn, Inc. NDC 61748-202-60 D-0385-2015
Class II · Moderate risk

ERYTHROMYCIN DR EC Tablet

Labeling: Label Mixup; ERYTHROMYCIN DR EC Tablet, 250 mg may be potentially mislabeled as methylPREDNISolone, Tablet, 4 mg, NDC 00781502201, Pedigree: AD46426_10, EXP: 5/15/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-536-2014
Class III · Low risk

Erythromycin Topical Solution USP

Chemical Contamination: This product is being recalled because trace amounts of a plasticizer (Di-Octyl Phthalate) may be present in the product.

Terminated Chemical / undeclared Fougera Pharmaceuticals, Inc. NDC 0168-0215-60 D-1426-2012