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

Yes — there is an active recall. 17 ongoing FDA recalls mention Phenylephrine (292 total). Check the affected lots below.

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

Phenylephrine recalls on record

none so far in 2026; 292 on record, newest first
Class II · Moderate risk

Lidocaine/Phenylephrine PF 1%/1.5% Injectible vials

Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS/failed results were reported to customers as passing. Hence the sterility of these products cannot be assured.

Terminated Sterility / contamination Leiter's Pharmacy D-1041-2013
Class II · Moderate risk

DayQuil Sinex DayTime Sinus Relief

Unit Dose Mispackaging: Product packaging defect which could result in code date smearing, incomplete blister card cuts, and missing or incorrectly placed liquicaps within the blisters.

Terminated Labeling / mix-up Procter & Gamble Co D-827-2013
Class II · Moderate risk

Theraflu Cold and Flu

Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

Terminated Particulate / foreign matter Novartis Consumer Health D-763-2014
Class II · Moderate risk

Theraflu Exte

Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

Terminated Particulate / foreign matter Novartis Consumer Health D-762-2014
Class II · Moderate risk

Theraflu

Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

Terminated Particulate / foreign matter Novartis Consumer Health NDC 0067-6319-06 D-751-2014
Class II · Moderate risk

Lidocaine 4%/Phenylephrine 1% 5

The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.

Terminated Other Main Street Family Pharmacy, LLC D-164-2014
Class III · Low risk

Excedrin

Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing

Terminated Impurity / degradation Novartis Consumer Health NDC 0067-2062-02 D-744-2014
Class III · Low risk

Theraflu Warming Relief

Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing

Terminated Impurity / degradation Novartis Consumer Health NDC 0067-6438-08 D-742-2014
Class III · Low risk

Maximum Strength Comtrex

Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.

Terminated Impurity / degradation Novartis Consumer Health NDC 0067-2081-24 D-741-2014
Class III · Low risk

Maximum Strength Comtrex

Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.

Terminated Impurity / degradation Novartis Consumer Health NDC 0067-2084-24 D-740-2014
Class II · Moderate risk

Pentrexcilina

Labeling: Not Elsewhere Classified: Pentrexcilina Tablets and Pentrexcilina Liquid are being recalled because the product labels are misleading because they may be confused with Pentrexyl, a prescription antibiotic used to treat respiratory illnesses in Mexico.

Terminated Labeling / mix-up Opmx, LLC D-299-2013
Class II · Moderate risk

Phenylephrine Injection

Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Terminated Sterility / contamination FVS Holdings, Inc. dba. Green Valley Drugs D-398-2013