The Recall Desk
ModerateFDA (Drugs)·D-1617-2014·Announced 2014-10-08

Actavis Recalls Diclofenac Sodium and Misoprostol Tablets Due to Splitting

Actavis is recalling 6,041 bottles of Diclofenac Sodium and Misoprostol tablets because they may be split or broken.

What this means for you

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: The recall is classified as FDA Class II and involves a physical defect (split/broken tablets) without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Actavis Laboratories, FL, Inc. is recalling 6,041 bottles of Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 50 mg/0.2 mg, 60-count bottles. The recall was initiated due to complaints that the tablets were split or broken.

The affected product is identified by Lot # 660513A with an expiration date of 10/31/2014. The product was distributed nationwide and in Puerto Rico. The tablets are prescription-only and were manufactured by Watson Laboratories, Inc.

Consumers should check their medication for the specific lot number and expiration date. If the product matches the recalled lot, they should stop using it and contact their pharmacist or healthcare provider for guidance on disposal or replacement.

The recalled product

Product
DICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL)
Brand
DICLOFENAC SODIUM AND MISOPROSTOL
Manufacturer
Actavis Laboratories, FL, Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
6,041

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 #: 660513A
  • Exp. 10/31/2014

UPCs (1)

  • 305910397609

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Actavis Laboratories, FL, Inc. 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 2 products in this recall →

Related recalls

Same brand · DICLOFENAC SODIUM AND MISOPROSTOL

Same manufacturer · Actavis Laboratories, FL, Inc.

See all →

Same hazard · physical defect

See all →