RecallRadar

FDA Drug recall D-0662-2016

ACETAMINOPHEN EXTRA-STRENGTH PAIN RELIEVER tablets, 500 mg, 100-count bottle, Distributed by Medline Industries, Inc., Mundelein, ILL 60060…

On 2016-02-24 the FDA classified a Class I recall of ACETAMINOPHEN EXTRA-STRENGTH PAIN RELIEVER tablets, 500 mg, 100-count bottle, Distributed by Medline Industries, Inc., Mundelein, ILL 60060… by Medline Industries, citing labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets mislabeled to contain 325 mg tablets.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0662-2016
ClassificationClass I
Statusterminated
Initiated2015-09-25
Published2016-02-24
Last updated2026-09-13 11:51 UTC
CompanyMedline Industries
DistributionUS

Product

ACETAMINOPHEN EXTRA-STRENGTH PAIN RELIEVER tablets, 500 mg, 100-count bottle, Distributed by Medline Industries, Inc., Mundelein, ILL 60060, NDC 53329-641-30.

Reason

Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets mislabeled to contain 325 mg tablets.

Identifiers

code_infolot # 45810; Exp. 05/18

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0662-2016%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.