Equaline Nasal Oxymetazoline HCl Nasal Spray Recalled for Contaminated Excipient
Perrigo Company PLC is recalling 1,560 bottles of Equaline Nasal No Drip Nasal Spray nationwide due to contaminated excipient used during manufacturing. The contaminated ingredient was sourced from a recalled excipient supplier.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall for a drug manufactured with a CGMP deviation involving a contaminated excipient from a recalled supplier. The source text does not report any illness, injury, or hospitalization, and the specific nature and risk posed by the contaminated excipient are not disclosed. This aligns with a Moderate severity classification for a precautionary CGMP-based recall without reported adverse events.
Plain-English summary
Perrigo Company PLC is recalling Equaline Nasal No Drip Nasal Spray (Oxymetazoline HCl 0.05%, 1 FL Oz / 30 mL bottles) distributed nationwide in the USA. The recall affects 1,560 bottles with batch number 1BK0964 and expiration date 01/31/2023. NDC: 41163-703-10.
The product was manufactured with a contaminated excipient that was itself recalled by the excipient supplier. This represents a deviation from Current Good Manufacturing Practices (CGMP).
Consumers who have purchased this product should stop using it. Consult a healthcare provider if you have questions about your health or exposure to the recalled product.
The recalled product
- Product
- EQUALINE NASAL (OXYMETAZOLINE HCL)
- Brand
- EQUALINE NASAL
- Manufacturer
- Perrigo Company PLC
- Category
- Drug — Nasal Decongestant / OTC
- Hazard
- contaminated-excipient
- cgmp-deviation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Batch: 1BK0964
- Exp 01/31/2023
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · EQUALINE NASAL
- ModerateEqualine Nasal Spray Recalled for Contaminated Excipient
FDA (Drugs) · 2022-03-02
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-06-17
- SevereCIMZIA injection recalled due to lack of sterility assurance
FDA (Drugs) · 2026-05-27
- SevereAtomoxetine Capsules Recalled Due to Labeling Mix-Up Error
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled Due to Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27