The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0924-2018·Announced 2018-07-25

Sun Pharmaceutical Recalls Metformin Hydrochloride Tablets Due to Foreign Matter

Sun Pharmaceutical Industries is recalling one lot of Metformin Hydrochloride Extended Release Tablets because a piece of rubber glove was detected in a tablet.

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: The recall is classified as FDA Class II, which corresponds to a moderate severity score under the rubric for minor labeling errors or low-risk contamination where the hazard is not likely to cause serious adverse health consequences.

Plain-English summary

Sun Pharmaceutical Industries, Inc. is recalling one lot of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg, packaged in 500-count bottles. The recall is due to the presence of foreign matter, specifically a piece of rubber glove, which was detected in one tablet.

The affected product is identified by Lot # JKT0042A with an expiration date of 1/2021. The recall involves 2,508 bottles distributed in Arizona. The product is a prescription-only medication manufactured by Sun Pharmaceutical Industries Ltd. in India and distributed by Sun Pharmaceutical Industries, Inc. in Cranbury, New Jersey.

Consumers who have this specific lot of medication should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement. The recall is limited to the specific lot number and expiration date listed above.

The recalled product

Product
METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
Brand
METFORMIN HYDROCHLORIDE
Manufacturer
Sun Pharmaceutical Industries, Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
2,508

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 #: JKT0042A
  • Exp 1/2021

UPCs (2)

  • 0362756142015
  • 0362756143012

Distribution

Distributed in 1 state:

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