Has AbbVie Inc. had other FDA recalls or enforcement actions?

This is the only FDA action Argus HQ has on file for AbbVie Inc. so far. Argus ingests new FDA enforcement records daily.

What is the current status of this recall?

Status as recorded by FDA: Ongoing.

Where can I verify this recall directly with FDA?

The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.

FDA Class III Recall: PRED MILD by AbbVie Inc. — Recall Details

Key facts

Recalling firm	AbbVie Inc.
Manufacturer	Allergan, Inc.
Brand name	PRED MILD
Product description	PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx only, Allergen, Inc., an AbbVie company, North Chicago, IL 60064, Product of France, NDC 11980-174-10.
Classification	Class III
Recall number	D-0551-2026
Report date	Not disclosed in the FDA record.
Status	Ongoing
Reason for recall	Failed Stability Specifications

Key takeaway: AbbVie Inc. recalled PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx only, Allergen, Inc., an AbbVie company, North Chicago, IL 60064, Product of France, NDC 11980-174-10. on 2026-06-03. FDA classified this action as a Class III recall (recall number D-0551-2026). Reason for recall: Failed Stability Specifications. Recall status: Ongoing. This is a drug-category FDA recall record. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

What consumers should do

Because FDA considers adverse health consequences unlikely for a Class III recall, the recommended action is still to stop using the product and follow the recalling firm's instructions, since a recall means the product did not meet FDA requirements. Specifically, check whether the product in your possession matches the description on file with FDA -- PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx only, Allergen, Inc., an AbbVie company, North Chicago, IL 60064, Product of France, NDC 11980-174-10. -- and the recall number D-0551-2026. If it matches, stop using or distributing it and contact AbbVie Inc. or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice.

What this classification means

FDA classifies a recall as Class III when using the recalled product, or being exposed to it, is not likely to cause any adverse health consequences. In this case, the recalling firm is AbbVie Inc. and the affected product is described in FDA's record as: PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx only, Allergen, Inc., an AbbVie company, North Chicago, IL 60064, Product of France, NDC 11980-174-10.. FDA's stated reason for the recall is: Failed Stability Specifications. The recall is tracked under FDA recall number D-0551-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended. Adverse events believed to be related to a recalled product can be reported to FDA's MedWatch program, which FDA uses to monitor safety signals after a recall is opened.

AbbVie Inc.’s FDA history

Argus HQ has recorded 1 total FDA action tied to AbbVie Inc.: 0 warning letters, 1 recall, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

Has AbbVie Inc. had other FDA recalls or enforcement actions?: This is the only FDA action Argus HQ has on file for AbbVie Inc. so far. Argus ingests new FDA enforcement records daily.
What is the FDA recall number for this event?: FDA recall number D-0551-2026.
What is the current status of this recall?: Status as recorded by FDA: Ongoing.
Where can I verify this recall directly with FDA?: The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.

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Full FDA history for AbbVie Inc.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). FDA Class III Recall: PRED MILD by AbbVie Inc. — Recall Details. Digital Empire LLC. Retrieved from https://argushq.ai/recall/fda-recall-abbvie-inc-d-0551-2026

MLA

"FDA Class III Recall: PRED MILD by AbbVie Inc. — Recall Details." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/recall/fda-recall-abbvie-inc-d-0551-2026.

Chicago

Argus HQ Research. "FDA Class III Recall: PRED MILD by AbbVie Inc. — Recall Details." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/recall/fda-recall-abbvie-inc-d-0551-2026.

BibTeX

@misc{argushq_argushq_ai_recall_fda_recall_abbvie_inc_d_0551_2026_2026,
  title = {FDA Class III Recall: PRED MILD by AbbVie Inc. — Recall Details},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/recall/fda-recall-abbvie-inc-d-0551-2026},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Recalls ↗