The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0539-2025·Announced 2025-07-30

Evenity prefilled syringes recalled after potential temperature excursions during transit delays

Evenity (romosozumab-aqqg) injection 105 mg/1.17 mL is being recalled because of CGMP deviations involving potential temperature excursions due to transit delays. 2 pre-filled syringes affected.

The agency’s classification

FDA (Drugs): Class II

Class II is 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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall over a potential temperature excursion in transit, with no confirmed potency or stability failure stated in the source.

Plain-English summary

Evenity (romosozumab-aqqg) injection, 105 mg/1.17 mL, for subcutaneous use only, prescription only, manufactured by Amgen Inc. of Thousand Oaks, California, NDC 55513-880-02, is being recalled. The action covers 2 pre-filled syringes.

The stated reason is CGMP deviations: potential temperature excursions due to transit delays. The FDA classified the action as Class II. The source does not report any confirmed loss of potency or stability.

The affected lot is 1178382, expiring 3/31/2027. Distribution was within the US, in Ohio, Virginia and Florida.

Facilities should identify affected stock using the NDC and lot number above and follow the instructions issued by Amgen.

The recalled product

Product
EVENITY (ROMOSOZUMAB-AQQG)
Brand
EVENITY
Manufacturer
Mckesson Medical-Surgical Inc. Corporate Office
Category
Drug — Injectable biologic
Hazard
Affected units
2

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 (2)

  • Lot: 1178382
  • Expiration date: 3/31/2027

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 3 recalled by Mckesson Medical-Surgical Inc. Corporate Office 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 3 products in this recall →

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