Tylenol and Acetaminophen Products Recalled Due to Improper Storage
Family Dollar Stores is recalling multiple Tylenol and acetaminophen products due to CGMP deviations involving improper storage temperature conditions. Products were distributed nationwide through specific Family Dollar locations from April 30, 2022 through June 10, 2022.
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 of medications due to improper storage temperature conditions (CGMP deviation). No illnesses or injuries are reported in the source, making this a theoretical risk-of-harm scenario. Per the rubric, this qualifies as 'risk-of-harm products where injury has not yet been reported,' warranting score 3.
Plain-English summary
Family Dollar Stores, LLC is recalling multiple Tylenol and acetaminophen products due to Current Good Manufacturing Practice (CGMP) deviations. The products were held outside of appropriate storage temperature conditions.
The recalled products include Acetaminophen PM Caplets (24 count), Tylenol Child Grape liquid (4 fl oz), Tylenol Child Oral Suspension Cherry (4 fl oz), Tylenol Infants Drops DF Cherry (1 oz), Tylenol PM Caplets (24 count), Tylenol Extra Strength Caplets (24 count), and Tylenol 8HR Muscle Ache Pain Relief Caplets (24 count). The affected SKUs are 900559, 901600, 913104, 999108, 900603, 916986, and 901155.
These products were distributed to specific Family Dollar Store locations nationwide from April 30, 2022 through June 10, 2022. The FDA classification for this recall is Class II.
The recalled product
- Product
- Ready in case ACETAMINOPHEN PM CAPLETS 24 CT SKU 900559; TYLENOL CHILD GRAPE 4 FL OZ SKU 901600 TYLENOL CHILD ORAL SUSPENSION CHERRY 4 FO 913104 TYLENOL INFANTS DROPS DF CHERRY 1OZ SKU 999108 TYLENOL PM CAPLET 24 CT SKU 900603 TYLENOL EXTRA STRENGTH CAPLET 24 CT SKU 91698
- Manufacturer
- Family Dollar Stores, Llc.
- Hazard
- improper-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 (7)
- SKUs:900559
- 901600
- 913104
- 999108
- 900603
- 916986
- 901155
Distribution
Distributed nationwide across the United States.
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