The Recall Desk
HighCPSC·22162·Announced 2022-06-16

Kroger Acetaminophen Recalled for Non-Child-Resistant Packaging

Sun Pharmaceutical is recalling Kroger brand acetaminophen 650 mg extended-release caplets because the packaging does not meet child-resistant requirements under the Poison Prevention Packaging Act, posing a risk of poisoning if swallowed by young children.

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 a risk-of-harm product (non-child-resistant packaging of an OTC drug) where no injuries or illnesses have been reported. Per the rubric, products with risk of harm where injury has not yet been reported score 3 (High).

Plain-English summary

Sun Pharmaceutical Industries Inc. is recalling Kroger brand acetaminophen, 650 mg extended-release caplets in 100-count bottles because the packaging fails to meet child-resistant packaging requirements mandated by the Poison Prevention Packaging Act (PPPA). Acetaminophen is a regulated substance that must be distributed in child-resistant packaging to prevent accidental poisoning.

About 34,660 units were distributed across multiple retailers under the Kroger Co. banner, including Baker's, City Market, Dillons, Fred Meyer, Fry's Food and Drug, Gerbes, JayC, King Soopers, Kroger, Mariano's, Metro Market, Payless Super Market, Pick 'n Save, Smith's, and related Marketplace locations nationwide from October 2021 through March 2022, priced at about $9 per bottle.

The recalled product has UPC number 041260012877 and batch codes AC45463, AC38213, or AC30682, located on the label of the red, white, and gray labeled 100-caplet bottle with white continuous thread closure.

Consumers should immediately store the recalled product in a safe location out of reach and sight of children. Contact Kroger at 800-576-4377 (800-KRO-GERS) from 7 a.m. to midnight ET Monday through Friday, or 7 a.m. to 9:30 p.m. ET Saturday and Sunday, or visit www.kroger.com/i/recall-alerts or www.sunpharma.com/usa for refund instructions and additional information.

The recalled product

Product
Kroger Acetaminophen, 100 count bottles
Manufacturer
Sun Pharmaceutical Industries Inc., of Princeton, New Jersey
Category
Drug — Over-the-counter pain reliever
Hazard
  • non-child-resistant-packaging
  • poisoning-risk
Affected units
34,660

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

UPCs (1)

  • 041260012877

Distribution

Distributed nationwide across the United States.

Related recalls

Same category