The Recall Desk
ModerateFDA (Drugs)·D-1616-2014·Announced 2014-10-08

Actavis Recalls Diclofenac Sodium and Misoprostol Tablets Due to Splitting

Actavis is recalling 36,538 bottles of Diclofenac Sodium and Misoprostol tablets due to complaints of split or broken tablets.

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 the hazard involves physical defects (split/broken tablets) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.

Plain-English summary

Actavis Laboratories, FL, Inc. is recalling 36,538 bottles of Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count. The recall is being conducted due to complaints of split or broken tablets.

The affected product is a prescription-only medication manufactured by Watson Laboratories, Inc. The specific lots involved are 605956A, 605958A, 644678M, and 661841A, with expiration dates ranging from September 2014 to February 2015. The product was distributed nationwide and in Puerto Rico.

Consumers and healthcare providers should stop using the affected product and return it to the pharmacy or point of purchase. Patients should consult their healthcare provider for alternative treatment options if necessary.

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
36,538

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 (9)

  • Lot #: 605956A
  • 605958A
  • Exp. 9/30/2014
  • 644678M
  • Exp. 10/31/2014
  • 661841A
  • Exp. 11/30/2014
  • 717469A
  • Exp 2/28/2015

UPCs (1)

  • 305910398606

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.

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Same hazard · physical defect

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