West-ward Recalls Prednisone Tablets Due to Gray Defects
West-ward Pharmaceutical Corp. is recalling specific lots of PredniSONE Tablets, USP, 10 mg, due to the presence of gray defects in 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 involves a situation that could cause temporary or medically reversible adverse health consequences. The presence of gray defects is a quality issue without reported serious injury or death, fitting the Moderate severity criteria for low-risk contamination or labeling/quality errors.
Plain-English summary
West-ward Pharmaceutical Corp. is recalling 128,319 bottles of PredniSONE Tablets, USP, 10 mg. The recall involves 100-count and 1,000-count bottles (NDC 0143-1473-01 and NDC 0143-1473-10) manufactured by West-ward Pharmaceutical Corp. in Eatontown, NJ.
The recall was initiated due to the presence of a foreign substance, specifically gray defects identified in the tablets. The affected lots are 69403A, 69403B (Exp 10/15); 69404A, 69405A, 69515A, 69702A, 69702B, 69703A (Exp 11/15); and 69767A, 69767B (Exp 12/15). These products were distributed nationwide and in Puerto Rico.
Consumers should check their medication for the specific lot numbers and expiration dates listed above. If the medication matches the recalled lots, patients should contact their healthcare provider or pharmacist for guidance on disposal or replacement.
The recalled product
- Product
- PredniSONE Tablets, USP, 10 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1473-01), b) 1000-count tablets per bottle (NDC 0143-1473-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatowntown, NJ 07724.
- Manufacturer
- West-ward Pharmaceutical Corp.
- Category
- Drug — Prescription Medication
- Affected units
- 128,319
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 (13)
- Lot #: 69403A
- 69403B
- Exp 10/15
- 69404A
- 69405A
- 69515A
- 69702A
- 69702B
- 69703A
- Exp 11/15
- 69767A
- 69767B
- Exp 12/15
Distribution
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