PAIN AID ESF- (ULTRAtab) – Laboratory Investigation (2021)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
PAIN AID ESF- (Acetaminopehn USP 250mg, Asprin USP 250mg Caffeine 65mg) coated, bulk OTC tablets packaged in corrugated boxes lined with 2 polyethylene bags 100 lb, ULTRAtab Laboratories, Inc. NDC# 62959-560-00, Product Code M560L
Brand
ULTRAtab Laboratories, Inc.
Lot Codes / Batch Numbers
Bulk Lots: 18K070, exp. date Nov-21, 19A046, exp. date Jan-22, 19C073, exp. date Mar-22, 19E014, exp. date May-22, 19G039, exp. date Jul-22, 19K002, exp. date Nov-22, 20A013, exp. date Jan-23, 20B050, exp. date Feb-23, 20C011, exp. date Mar-23, 20C049, exp. date Mar-23, 20F071, exp. date Jun-23, 20F072, exp. date Jun-23, 20G033, exp. date Jul-23, 20G041, exp. date Jul-23.
Products Sold
Bulk Lots: 18K070, exp. date Nov-21; 19A046, exp. date Jan-22; 19C073, exp. date Mar-22; 19E014, exp. date May-22; 19G039, exp. date Jul-22; 19K002, exp. date Nov-22; 20A013, exp. date Jan-23; 20B050, exp. date Feb-23; 20C011, exp. date Mar-23; 20C049, exp. date Mar-23; 20F071, exp. date Jun-23; 20F072, exp. date Jun-23; 20G033, exp. date Jul-23; 20G041, exp. date Jul-23.
ULTRAtab Laboratories, Inc. is recalling PAIN AID ESF- (Acetaminopehn USP 250mg, Asprin USP 250mg Caffeine 65mg) coated, bulk OTC tablets pac due to CGMP Deviations: failed stability results, inadequate laboratory investigations,. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
CGMP Deviations: failed stability results, inadequate laboratory investigations,
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026