The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0824-2021·Announced 2021-09-29

Chlorzoxazone 750 mg Tablets Recalled Due to CGMP Deviations

Glenmark Pharmaceuticals is recalling Chlorzoxazone 750 mg tablets nationwide due to current good manufacturing practice (CGMP) deviations. The voluntary recall affects 4,752 bottles with five affected lot numbers.

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: This is an FDA Class II voluntary recall with no reported illnesses or injuries. The hazard is manufacturing deviations without evidence of actual patient harm, which aligns with the Moderate category for precautionary recalls without reported adverse events.

Plain-English summary

Glenmark Pharmaceuticals Inc., USA is voluntarily recalling Chlorzoxazone Tablets USP 750 mg (NDC 68462-725-01) due to current good manufacturing practice (CGMP) deviations identified during manufacturing. The affected product consists of 4,752 bottles distributed nationwide.

The recall involves five specific lot numbers: 29200023 (expiration 03/31/2022), 29200025 (expiration 03/31/2022), 29200036 (expiration 06/30/2022), 29200056 (expiration 09/30/2022), and 29200070 (expiration 11/30/2022).

Chlorzoxazone is a muscle relaxant medication available by prescription only. Patients currently taking this medication should consult their healthcare provider or pharmacist about their supply and whether a replacement product is appropriate. Patients should not stop taking their medication without medical guidance.

The recall was initiated on August 27, 2021, classified as Class II by the FDA, and terminated on October 4, 2023.

The recalled product

Product
Chlorzoxazone Tablets USP 750 mg 100 Tablets Rx Only NDC 68462-725-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
Manufacturer
Glenmark Pharmaceuticals Inc., USA
Category
Drug — Prescription Muscle Relaxant
Hazard
Affected units
4,752

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 (5)

  • Lots: 29200023 Exp. 03/31/2022
  • 29200025 Exp. 03/31/2022
  • 29200036 Exp. 06/30/2022
  • 29200056 Exp. 09/30/2022
  • 29200070 Exp. 11/30/2022

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 recalled by Glenmark Pharmaceuticals Inc., USA 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 8 products in this recall →

Related recalls

Same manufacturer · Glenmark Pharmaceuticals Inc., USA

See all →

Same hazard · cgmp deviation

See all →

Similar recalls