Mylicon Infant Gas Drops Recalled Due to Temperature Storage Deviation
Family Dollar Stores is recalling Mylicon Infant Gas Drops 0.5 oz distributed nationwide from April 30 through June 10, 2022 due to improper storage temperature conditions.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for improper storage of an infant medication. Storage-temperature deviations can affect medication stability and safety, particularly for vulnerable infant consumers, warranting High severity classification.
Plain-English summary
Family Dollar Stores, Llc. is recalling Mylicon Infant Gas Drops 0.5 oz due to Current Good Manufacturing Practice (CGMP) deviations. The product was held outside of appropriate storage temperature conditions.
The affected product was distributed nationwide to Family Dollar Stores between April 30, 2022 and June 10, 2022. The product is identified by SKU 999109 and is sold in 0.5 oz bottles.
The recalled product
- Product
- MYLICON INFANT GAS DROPS 0.5 OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
- Manufacturer
- Family Dollar Stores, Llc.
- Category
- Drug — Infant Medication
- Hazard
- storage-temperature-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 (1)
- SKU:999109
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateMethohexital Sodium for Injection Recalled for Failed Impurities and Degradation Specifications
FDA (Drugs) · 2026-07-15
- SevereBortezomib for Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15
- SevereAzacitidine for Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15
- ModerateGasco Isopropyl Alcohol 70% recalled nationwide for subpotency
FDA (Drugs) · 2026-07-15