West-ward Recalls Carisoprodol Tablets Due to Foreign Substance Presence
West-ward Pharmaceutical Corp. is recalling 8,585 bottles of Carisoprodol Tablets, USP, 350 mg, due to the presence of uncharacteristic black spots on the 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, which typically indicates a situation where use of the product might cause temporary or medically reversible health consequences. The presence of foreign substance (black spots) is a quality defect that warrants a moderate severity rating under the rubric for low-risk contamination or labeling/packaging issues, as no specific illness or injury is reported in the source text.
Plain-English summary
West-ward Pharmaceutical Corp. is recalling 8,585 bottles of Carisoprodol Tablets, USP, 350 mg, which are packaged in 500-count and 1000-count bottles. The recall is being conducted because of the presence of a foreign substance, specifically uncharacteristic black spots on the tablets.
The affected product is prescription-only and was distributed nationwide. The specific lots involved are 69364A, 69365A, and 69365B, all with an expiration date of 10/15. The NDC numbers for the affected packaging are 0143-1176-05 and 0143-1176-10.
Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be returned to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider regarding alternative medication options if they have been prescribed this specific product.
The recalled product
- Product
- Carisoprodol Tablets, USP, 350 mg, packaged in a) 500-count tablets per bottle (NDC 0143-1176-05) and b) 1000-count tablets per bottle (NDC 0143-1176-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724.
- Manufacturer
- West-ward Pharmaceutical Corp.
- Category
- Drug — Prescription Medication
- Affected units
- 8,585
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 (4)
- Lot #: 69364A
- 69365A
- and 69365B
- Exp 10/15
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · West-ward Pharmaceutical Corp.
See all →- ModerateWest-Ward Recalls Fentanyl Citrate Injection Due to Impurity Failures
FDA (Drugs) · 2015-06-24
- ModerateWest-Ward Recalls Ethambutol Hydrochloride Tablets Due to Stability Failure
FDA (Drugs) · 2014-11-05
- ModerateWest-Ward Recalls Isoniazid Tablets Due to Dissolution Failure
FDA (Drugs) · 2014-07-09
- SevereWest-Ward Recalls Carisoprodol Tablets Due to Foreign Substance Presence
FDA (Drugs) · 2013-12-25
- SevereIrinotecan Hydrochloride Injection Recalled for Incorrect Formulation Calculation
FDA (Drugs) · 2013-11-13
Same hazard · foreign substance
See all →- ModerateHeritage Pharmaceuticals Recalls Clindamycin Palmitate Hydrochloride Due to Foreign Particles
FDA (Drugs) · 2026-08-19
- HighPrednisolone Acetate Ophthalmic Suspension Recalled for Foreign Substance
FDA (Drugs) · 2026-07-08
- ModerateCorlanor Ivabradine Tablets Recalled for Foreign Substance Contamination
FDA (Drugs) · 2026-07-01
- LowHydroxyzine Hydrochloride Oral Solution recalled for foreign substance
FDA (Drugs) · 2026-07-01
- ModerateCorlanor ivabradine tablets recalled for presence of foreign substance
FDA (Drugs) · 2026-07-01