FDA Recalls Sterile Alcohol Prep Pads Due to Improper Storage
Mckesson Medical-Surgical is recalling ALCOHOL PREP sterile alcohol prep pads nationwide because they were stored outside manufacturer specifications, potentially compromising sterility. FDA classified this as a Class II recall.
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 sterile medical product where improper storage could compromise sterility assurance. No illnesses or injuries have been reported. Per the rubric, this qualifies as a risk-of-harm product where injury has not been reported, warranting a High severity score.
Plain-English summary
Mckesson Medical-Surgical Inc. is recalling ALCOHOL PREP sterile alcohol prep pads (isopropyl alcohol, NDC 67777-121-16) distributed nationwide. The recall affects 10 boxes of sterile, latex-free alcohol prep pads containing 100 large pads per box, part number 1116, manufactured for Dynarex Corporation.
The recall was initiated because the products were stored outside the specifications listed on the drug label, a violation of FDA Current Good Manufacturing Practice (CGMP) requirements. When sterile medical products are stored improperly, the integrity of their sterility assurance may be compromised.
This product was distributed nationwide in the USA. Healthcare facilities, clinics, hospitals, and other settings using these alcohol prep pads may be affected.
Consumers and healthcare providers should discontinue use of the recalled product and contact Mckesson Medical-Surgical Inc. for replacement or return instructions. Check product code Part# 1116 or the NDC 67777-121-16 to verify if your supply is affected.
The recalled product
- Product
- ALCOHOL PREP (ISOPROPYL ALCOHOL)
- Brand
- ALCOHOL PREP
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Topical Antiseptic Prep
- Hazard
- improper-storage
- sterility-risk
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 (1)
- Part# 1116
UPCs (3)
- 0840117333307
- 0840117333321
- 0840117333345
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27