Sun Pharma Recalls Kroger Brand Acetaminophen Due to Failure to Meet Child Resistant Packaging Requirement; Risk of P... — CPSC recall 22162

Published notice; closure not supplied

The CPSC record supplies a notice and remedy, not a current closure determination.

Source date Jun 16, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product
This recall involves the Kroger brand acetaminophen over-the-counter drug. The red, white and gray label states Kroger, Acetaminophen, Extended-Release Tablets USP, 650mg, Pain Reliever/Fever Reducer, 100 caplets. The bottle has a white continuous thread closure. The UPC number is 041260012877 with the batch codes AC45463, AC38213 or AC30682. The location of the UPC number is under the bar code on the packaging and the batch code is at the bottom of the label on the bottle.
Reason
The recalled over-the-counter product contains the regulated substance acetaminophen which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the product is not child resistant, posing a risk of poisoning if the contents are swallowed by young children.
Classification
Not supplied
Recalling firm
Sun Pharmaceutical Industries Inc., of Princeton, New Jersey; The Kroger Co., of Cincinnati, Ohio
Quantity
About 34,660
Agency-reported status
Published recall notice
Source record identifier
22162

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Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicability041260012877

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Not supplied

No US distribution state could be established from this record. Check the official notice.

Dates in the source

Last publish date
Jun 16, 2022

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

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