Western Drug Recalls Benadryl Injection Due to Sterility Concerns
Western Drug is recalling Benadryl 50mg/2mL Pres-Free Injection because the product lacks assurance of sterility. The recall covers all lots distributed nationwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score according to the rubric.
Plain-English summary
Western Drug Inc. is recalling Benadryl 50mg/2mL Pres-Free Injection, a prescription medication. The recall is being conducted because the product lacks assurance of sterility.
The recall includes all lots of the product. The medication was distributed nationwide in the United States, specifically in Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider for further instructions.
The recalled product
- Product
- Benadryl 50mg/2mL Pres-Free Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
- Manufacturer
- Western Drug
- Category
- Drug — Injection
- Hazard
- Affected units
- 1
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)
- all lots
Distribution
Part of a larger recall action
This product is one of 91 recalled by Western Drug under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 91 products in this recall →Related recalls
Same manufacturer · Western Drug
See all →- SevereWestern Drug Recalls Sodium Hydroxide 10% Injection Due to Sterility Concerns
FDA (Drugs) · 2015-12-09
- SevereWestern Drug Recalls Methylcobalamin Injection Due to Sterility Concerns
FDA (Drugs) · 2015-12-09
- SevereWestern Drug Recalls PZI 40 Insulin Due to Sterility Concerns
FDA (Drugs) · 2015-12-09
- SevereWestern Drug Recalls Ketorolac Injection Due to Sterility Concerns
FDA (Drugs) · 2015-12-09
- SevereWestern Drug Recalls VitB12/VitC/VitB3/VitB9 Injections Due to Sterility Concerns
FDA (Drugs) · 2015-12-09
Same hazard · sterility
See all →- SevereRegeneron Recalls Libtayo Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-08-26
- SeverePrestige Recalls Clear Eyes Maximum Itchy Eye Relief Due to Sterility Concerns
FDA (Drugs) · 2026-08-19
- SevereFDA Recalls ROHTO OPTIC GLOW Eye Drops Over Sterility Concerns
FDA (Drugs) · 2026-07-29
- HighROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29
- SevereROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29